Meperidine Hydrochloride (Demerol)

Trade Name : Demerol

Validus Pharmaceuticals LLC

TABLET

Strength 50 mg/1

MEPERIDINE HYDROCHLORIDE Full Opioid Agonists [MoA],Opioid Agonist [EPC]

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GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Meperidine Hydrochloride (Demerol) which is also known as Demerol and Manufactured by Validus Pharmaceuticals LLC. It is available in strength of 50 mg/1 per ml. Read more

Meperidine Hydrochloride (Demerol) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials. Click to know price. Read less

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Risk of Medication Errors
Ensure accuracy when prescribing, dispensing, and administering n- DEMEROL n- Oral Solution. Dosing errors due to confusion between mg and mL, and other Meperidine Hydrochloride Oral Solutions of different concentrations can result in accidental overdose and death n- [see Dosage and Administration (n- Arrayn- ), Warning and Precautions (n- Arrayn- )].
Addiction, Abuse, and Misuse
DEMEROL n- Tabletsn- u00a0n- and Oral Solution n- expose patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Assess each patientu2019s risk prior to prescribing DEMEROLn- u00a0n- Tabletsn- or Oral Solutionn- , and monitor all patients regularly for the development of these behaviors n- and n- conditions n- [see Warnings and Precautions (n- Arrayn- )].
Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS)
To ensure that the benefits of opioid analgesics outweigh the risks of addiction, abuse, and misuse, the Food and Drug Administration (FDA) has required a REMS for these products n- [see Warnings and Precautions (n- Arrayn- )]n- .Under the requirements of the REMS, drug companies with approved opioid analgesic products must make REMS-compliant education programs available to healthcare providers. Healthcare providers are strongly encouraged to
Life-Threatening Respiratory Depression
Serious, life-threatening, or fatal respiratory depression may occur with use of DEMEROLn- u00a0n- Tabletsn- and Oral Solutionn- . Monitor for respiratory depression, especially during initiation of DEMEROL n- Tabletsn- u00a0n- or Oral Solution, n- or following a dose increase n- [see Warnings and Precautions (n- Arrayn- )]n- .
Accidental Ingestion
Accidental ingestion of DEMEROLn- u00a0n- Tabletsn- and Oral Solutionn- , especially n- by n- children, can result in a fatal overdose of meperidine n- [see Warnings and Precautions (n- Arrayn- )]n- .
Neonatal Opioid Withdrawal Syndrome
Prolonged use of DEMEROL n- Tabletsn- u00a0n- or Oral Solution n- during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available n- [see Warnings and Precautions (n- Arrayn- )].
Cytochrome P450 3A4n- (CYP3A4)n- Interaction
The concomitant use of DEMEROLn- u00a0n- Tabletsn- u00a0n- or Oral Solution n- with all cytochrome P450 3A4n- (CYP3A4)n- inhibitors may result in an increase in meperidine plasma concentrations, which could increase or prolong adverse reactions and may cause potentially fatal respiratory depression. n- u00a0n- In addition, discontinuation of a concomitantly used cytochrome P450 3A4n- (CYP3A4)n- inducer may result in an increase in meperidine plasma concentration. n- u00a0n- Monitor patients receiving DEMEROL n- Tabletsn- u00a0n- or Oral Solution, n- and any CYP3A4 inhibitor or inducer n- [see Warnings and Precautions (n- Arrayn- ), Drug Interactions (n- Arrayn- )]n- .
Risks From Concomitant Use With Benzodiazepines Or Other CNS Depressants
Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death n- [see Warnings and Precautions (n- Arrayn- ), Drug Interactions (n- Arrayn- )].
Concomitant use of DEMEROL n- Tablets and Oral Solution n- with Monoamine n- On- xidasen- Inhibitorsn- (MAOn- Isn- )
Concomitant use of DEMEROL Tablets n- or Oral Solution n- with monoamine oxidase n- inhibitors n- (MAOn- Isn- ) can result in coma, severe respiratory depression, cyanosis, and hypotension.n- u00a0n- Use of DEMEROL n- Tablets n- orn- Oral Solution n- with MAOn- Isn- within last 14 days is contraindicatedn- u00a0n- [see Contraindications n- (n- Arrayn- ), Warnings and Precautions (n- Arrayn- ), Drug Interactions (n- Arrayn- )]n- .
See full prescribing information for complete boxed warning.

Ensure accuracy when prescribing, dispensing, and administering DEMEROL Oral Solution. Dosing errors due to confusion between mg and mL, and other Meperidine Hydrochloride Oral Solutions of different concentrations can result in accidental overdose and death. (n- Arrayn- , n- Arrayn- )
DEMEROL Tablets and Oral Solution expose users to risks of addiction, abuse, and misuse, which can lead to overdose and death. Assess patientu2019s risk before prescribing and monitor regularly for these behaviors and conditions. (n- Arrayn- )
To ensure that the benefits of opioid analgesics outweigh the risks of addiction, abuse, and misuse, the Food and Drug Administration (FDA) has required a Risk Evaluation and Mitigation Strategy (REMS) for these products. (n- Arrayn- )
Serious, life-threatening, or fatal respiratory depression may occur. Monitor closely, especially upon initiation or following a dose increase. n- u00a0n- (n- Arrayn- )
Accidental ingestion of DEMEROL Tablets or Oral Solution, especially by children, can result in a fatal overdose of meperidine. (n- Arrayn- )
Prolonged use of DEMEROL Tablets or Oral Solution during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated. If prolonged opioid use is required in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available. (n- Arrayn- )
Concomitant use with CYP3A4 inhibitors (or discontinuation of CYP3A4 inducers) can result in fatal overdose of meperidine (n- Arrayn- , n- Arrayn- )
Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing for use in patients for whom alternative treatment options are inadequate; limit dosages and durations to the minimum required; and follow patients for signs and symptoms of respiratory depression and sedation. (n- Arrayn- , n- Arrayn- )
Concomitant use of DEMEROL Tablets or Oral Solution with monoamine oxidase inhibitors (MAOIs) can result in coma, severe respiratory depression, cyanosis and hypotension. Use of DEMEROL Tablets or Oral Solution with MAOIs within the last 14 days is contraindicated. (n- Arrayn- , n- Arrayn- , n- Arrayn- )

DEMEROL Tabletsu00a0and Oral Solution are indicated for the managementu00a0of acute painu00a0severe enough to require an opioid analgesic and for which alternative treatments are inadequate.
Limitations of Use
Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses n n , reserve DEMEROL Tabletsu00a0oru00a0Oral Solution for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]:
DEMEROL Tabletsu00a0or Oral Solution should not be used for treatment of chronic pain. Prolonged DEMEROL Tabletu00a0oru00a0Oral Solution use may increase the risk of toxicity (e.g. seizures) from the accumulation of the meperidine metabolite, normeperidine.
DEMEROL Tablets and Oral Solution are opioid agonistsu00a0indicated for the management of pain,u00a0severe enough to require an opioid analgesic and for which alternative treatments are inadequate. ()
Limitations of Use
Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, reserve DEMEROL Tabletsu00a0and Oral Solution for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]:

Have not been tolerated, or are not expected to be tolerated,n
Have not provided adequate analgesia, or are not expected to provide adequate analgesia.u00a0

No data

Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals. ()n
Individualize dosing based on the severity of pain, patient response, prior analgesic experience, and risk factors for addiction, abuse, and misuse. () n
Adult Patients:
Pediatric Patients:
Do not stop DEMEROLu00a0Tabletsu00a0or Oral Solution abruptly in a physically dependent patient. ()

Tablets
Oral Solution
Tablets: 50 mg and 100 mg. ()
Oral Solution:u00a0u00a050mg/5mL (10 mg/mL)

DEMEROL Tabletsu00a0and Oral Solutionu00a0are contraindicated in patients with:

Significant respiratory depression. ()n
Acute or severe bronchial asthma in an unmonitored setting or in absence of resuscitative equipment. () n
Concomitant use of monoamine oxidase inhibitors (MAOIs) or within 14 days of having taken an MAOI. () n
Known or suspected gastrointestinal obstruction, including paralytic ileus. ()n
Hypersensitivity to meperidine or to any other ingredients of the product. ()

No data

Life-Threatening Respiratory Depression in Patients with Chronic Pulmonary Disease or in Elderly, Cachectic, n- or n- Debilitated Patients
Serotonin Syndrome
Adrenal Insufficiency
Severe Hypotension
Risks of Use in Patients with Increased Intracranial Pressure, Brain Tumors, Head Injury, or Impaired Consciousness

The following serious adverse reactions are described, or described in greater detail, in other sections:
The following adverse reactions associated with the use of meperidine were identified in clinical studies or postmarketing reports. Because some of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
The major hazards of meperidine, as with other opioid analgesics, are respiratory depression and, to a lesser degree, circulatory depression, respiratory arrest, shock, and cardiac arrest.
The most frequently observed adverse reactions included lightheadedness, dizziness, sedation,u00a0nausea, vomiting, and sweating.u00a0u00a0These effects seem to be more prominent in ambulatoryu00a0patients and in those who are not experiencing severe pain. u00a0In such individuals, lower doses are advisable. u00a0Some adverse reactions in ambulatory patients may be alleviated if the patient lies down.
Other adverse reactions include:
Nervous System:
Gastrointestinal:
Cardiovascular:n- [n- see Warnings and Precautions (n- Arrayn- )n- ]
Genitourinary:
Allergic:
Histamine release leading to hypotension and/or tachycardia, flushing, sweating, and pruritus.
Serotonin syndrome
Adrenal insufficiencyn- Array
Androgen deficiencyn- [see Clinical Pharmacology (n- Arrayn- )]
To report SUSPECTED ADVERSE REACTIONS, contact Validus Pharmaceuticals LLC at 1-866-982-5438 (1-866-9VALIDUS) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Most common adverse reactions were lightheadedness, dizziness, sedation, nausea, vomiting, and sweating. ()

Table 1 includes clinically significant drug interactions with DEMEROLu00a0Tablets and Oral Solution.

Mixed Agonist/Antagonist and Partial Agonist Opioid Analgesics
7

No data

Pregnancy
8.1

No data

Clinical Presentation
Acute overdose with DEMEROL Tabletsu00a0and Oral Solutionu00a0can be manifestedu00a0by respiratory depression,u00a0somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy skin,u00a0constricted pupils, and,u00a0in some cases, pulmonary edema, bradycardia, hypotension, partial or complete airway obstruction, atypical snoring, and death. Marked mydriasis rather than miosis may be seen with hypoxia in overdose situations n n .u00a0
Accumulation of normeperidine as in chronic use or possibly following introduction of a concomitant CYP3A4 inducer presents as excitatory syndrome including hallucinations, tremors, muscle twitches, dilated pupils, hyperactive reflexes, and convulsions.u00a0u00a0
Treatment n- of Overdose
In case of overdose, priorities are the reestablishment of a patent and protected airway and institution of assisted or controlled ventilation, if needed.u00a0u00a0Employ other supportive measures (including oxygen and vasopressors) in the management of circulatory shock and pulmonary edema as indicated. u00a0Cardiac arrest or arrhythmias will require advanced life-support techniques.u00a0
The opioidu00a0antagonists, naloxone or nalmefene, are specific antidotesu00a0to respiratory depression resulting from opioid overdose. u00a0For clinically significant respiratory or circulatory depression secondary to meperidine overdose, administer an opioid antagonist.u00a0 Opioid antagonists should not be administered in the absence of clinically significant respiratory or circulatory depressionu00a0secondary to meperidine overdose.
Because the duration of opioid reversal is expected to be less than the duration of action of meperidine in DEMEROLu00a0Tablets and Oral Solution, carefully monitor the patient until spontaneous respiration is reliably reestablished. u00a0If the response to an opioid antagonist is suboptimal or only brief in nature, administer additional antagonist as directed by the productu2019s prescribing information.
In an individual physically dependent on opioids, administration of the recommended usual dosage of the antagonist will precipitate an acute withdrawal syndrome. The severity the withdrawal symptoms experienced will depend on the degree of physical dependence and the dose of antagonist administered. If a decision is made to treat serious respiratory depression in the physically dependent patient, administration of the antagonist should be initiated with care and by titration with smaller than usual doses of the antagonist.

DEMEROL (meperidine hydrochloride, USP)u00a0Tabletu00a0and Oral Solution areu00a0opioid agonists.u00a0DEMEROL Tablets are available as 50 mg and 100 mg Tablets for oral administration. u00a0The chemical name is 4-Piperidinecarboxylic acid, 1-methyl-4-phenyl-,ethyl ester, hydrochloride. The molecular weight is 283,80. u00a0Its molecular formula is CHNOu00b7HCl, and it has the following chemical structure.
Meperidine hydrochloride is a white crystalline substance with a melting point of 186u00b0C to n 189u00b0C. u00a0It is readily soluble in water and has a neutral reaction and a slightly bitter taste. u00a0The solution is not decomposed by a short period of boiling.
The Tablets contain 50 mg or 100 mg of meperidine hydrochloride.
The DEMEROL Oral Solution is a pleasant-tasting, nonalcoholic, banana-flavored solution containing 50 mg of meperidine hydrochloride, per 5 mL (10 mg/mL).
The Inactive Ingredients in DEMEROLu00a0Tabletsu00a0include: Calcium Sulfate, Dibasic Calcium Phosphate, Starch, Stearic Acid, and Talc. u00a0Theu00a0Tablets are white, round and convex. u00a0The 50 mg is a scored tablet and has a stylized u201cWu201d on one side and u201cDu201d over u201c35u201d on the other side. u00a0The 100 mg is a scored tablet and has a stylized u201cWu201d on one side and u201cDu201d over u201c37u201d on the other side.
The Inactive Ingredients in DEMEROL Oral Solution include: Benzoic Acid, Flavor, Liquid Glucose, Purified Water, Saccharin Sodium.

No data

Carcinogenesis
Long-term studies in animals to evaluate the carcinogenic potential of meperidine have not been conducted.
Mutagenesis
Studies to in animals to evaluate the mutagenic potential of meperidine have not been conducted.
Impairment of Fertility
Studies to determine the effect of meperidine on fertility have not been conducted.

DEMEROL (meperidine hydrochloride)u00a0Tabletsu00a050 mg, are white, round, convex scored tablets debossed with u201cWu201d on one side and u201cDu201d over u201c35u201d on the other, and are supplied as: HDPE plastic bottles of 100 (NDC Number 30698-335-01)
DEMEROL (meperidine hydrochloride) Tabletsu00a0100 mg, are white, round, convex scored Tabletsu00a0debossed with u201cWu201d on one side and u201cDu201d over u201c37u201d on the other, and are supplied as: HDPE plastic bottles of 100 (NDC Number 30698-337-01)
DEMEROL (meperidine hydrochloride) Oral Solution, 50mg per 5mL (10 mg/mL) is non-alcoholic, banana-flavored syrup, and is supplied in 16 fl. oz. bottles (NDC Number 30698-332-16).
Store at 77u00b0F (25u00b0C); excursions permitted to 59u00b0 to 86u00b0F (15u00b0 to 30u00b0C) [See USP Controlled Room Temperature].

Advise the patient to read the FDA-approved patient labeling ().n
Medication Errors
Provide detailed instructions to patients on how to measure and take the correct dose of DEMEROL Oral Solution to ensure that the dose is measured and administered accurately n n .
If the prescribed dosage is changed, instruct patients on how to correctly measure the new dose to avoid errors which could result in accidental overdose and death.
Addiction, Abuse, and Misuse
Inform patients that the use of DEMEROLu00a0Tabletsu00a0or Oral Solution, even when taken as recommended, can result in addiction, abuse, and misuse, which can lead to overdose and death n n n u00a0u00a0Instruct patients not to share DEMEROL Tabletsu00a0or Oral Solution with others and to take steps to protect DEMEROL Tabletsu00a0or Oral Solution from theft or misuse.
Life-Threatening Respiratory Depression
Inform patients of the risk of life-threatening respiratory depression, including information that the risk is greatest when starting DEMEROLu00a0Tabletsu00a0or Oral Solution or when the dosage is increased, and that it can occur even at recommended dosages n n . Advise patients how to recognize respiratory depression and to seek medical attention if breathing difficulties develop.
Accidental Ingestion
Inform patients that accidental ingestion, especially by children, may result in respiratory depression or death n n . Instruct patients to take steps to store DEMEROL Tabletsu00a0or Oral Solution securely and to flush any unused tablets of DEMEROLu00a0Tabletsu00a0or Oral Solution down in the toilet.
Interactions with Benzodiazepines and Other CNS Depressants
Inform patients and caregivers that potentially fatal additive effects may occur if DEMEROL Tabletsu00a0or Oral Solution are used with benzodiazepines or other CNS depressants, including alcohol, and not to use these concomitantly unless supervised by a healthcare provider n n n n n
MAOI Interaction
Inform patients not to take DEMEROL Tabletsu00a0or Oral Solutionu00a0while using any drugs that inhibit monoamine oxidase. u00a0Patients should not start MAOIs while taking DEMEROL Tabletsu00a0or Oral Solutionu00a0n n n n n n n n
Serotonin Syndrome
Inform patients that opioids could cause a rare but potentially life-threatening condition resulting from concomitant administration of serotonergic drugs. Warn patients of the symptoms of serotonin syndrome and to seek medical attention right away if symptoms develop. Instruct patients to inform their healthcare providers if they are taking, or plan to take serotonergic medications. n n n n .
Adrenal Insufficiency
Inform patients that opioids could cause adrenal insufficiency, a potentially life-threatening condition. u00a0Adrenal insufficiency may present with non-specific symptoms and signs such as nausea, vomiting, anorexia, fatigue, weakness, dizziness, and low blood pressure. Advise patients to seek medical attention if they experience a constellation of these symptoms n n .
Important Administration Instructions
Instruct patients how to properly take DEMEROL Tabletsu00a0or Oral Solution.
Hypotension
Inform patients that DEMEROL Tabletsu00a0or Oral Solution may cause orthostatic hypotension and syncope. Instruct patients how to recognize symptoms of low blood pressure and how to reduce the risk of serious consequences should hypotension occur (e.g., sit or lie down, carefully rise from a sitting or lying position) n n .
Anaphylaxis
Inform patients that anaphylaxis has been reported with ingredients contained in DEMEROLu00a0Tabletsu00a0and Oral Solution. u00a0Advise patients how to recognize such a reaction and when to seek medical attention n n n n n n
Pregnancy
Neonatal Opioid Withdrawal Syndrome
Inform female patients of reproductive potential that prolonged use of DEMEROL Tabletsu00a0or Oral Solution during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treatedn n n n n n n n n
Embryo-Fetal Toxicity
Inform female patients of reproductive potential that DEMEROL Tabletsu00a0and Oral Solution can cause fetal harm and to inform healthcare provider of a known or suspected pregnancy n n n n
Lactation
Advise nursing mothers to monitor infants for increased sleepiness (more than usual), breathing difficulties, or limpness. Instruct nursing mothers to seek immediate medical care if they notice these signs n n .
Infertility
Inform patients that chronic use of opioids may cause reduced fertility. It is not known whether these effects on fertility are reversible n n n
Driving or Operating Heavy Machinery
Inform patients that DEMEROL Tabletsu00a0and Oral Solution may impair the ability to perform potentially hazardous activities such as driving a car or operating heavy machinery. Advise patients not to perform such tasks until they know how they will react to the medication n n .
Constipation
Advise patients of the potential for severe constipation, including management instructions and when to seek medical attention n n .
Disposal of Unused DEMEROLn- u00a0n- Tablets and Oral Solution
Advise patients to flush any unused tablets down in the toilet.
Manufactured for and n- Distributed byn- :
u00a9 2018 Validus Pharmaceuticals LLC
60037-08u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0September 2018

This Medication Guide has been approved by the U.S. Food and Drug Administration
60071-03 Issued: u00a0August 2017

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Meperidine Hydrochloride (Demerol)

Trade Name : Demerol

TABLET

Delivery Process

Product information is meant for

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Meperidine Hydrochloride (Demerol)

Trade Name : Demerol

TABLET

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate)

Fluoxetine Hydrochloride (Fluoxetine)

Metoprolol Succinate (Metoprolol Succinate)

Losartan Potassium (Losartan Potassium)

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