REGLAN Tablet Ref.[50363] Active ingredients: Metoclopramide

Source: FDA, National Drug Code (US)  Revision Year: 2020 

Product description

Metoclopramide hydrochloride, the active ingredient of Reglan, is a dopamine-2 receptor antagonist. Metoclopramide hydrochloride (metoclopramide monohydrochloride monohydrate) is a white crystalline, odorless substance, freely soluble in water. Its chemical name is 4-amino-5-chloro-N-[2-(diethylamino)ethyl]-2-methoxy benzamide monohydrochloride monohydrate.

The molecular formula is C14H22ClN3O2•HCl•H2O. Its molecular weight is 354.3. The structural formula is:

Reglan tablets are for oral administration. Reglan is available in 5 mg and 10 mg tablets.

  • Each Reglan 5 mg tablet contains 5 mg metoclopramide (equivalent to 5.91 mg of metoclopramide hydrochloride USP). Inactive ingredients consist of corn starch, D&C Yellow 10 Aluminum Lake, FD&C Blue 1 Aluminum Lake, lactose, microcrystalline cellulose, silicon dioxide, and stearic acid.
  • Each Reglan 10 mg tablet contains 10 mg metoclopramide (equivalent to 11.82 mg metoclopramide hydrochloride USP). Inactive ingredients consist of magnesium stearate, mannitol, microcrystalline cellulose, and stearic acid.
Dosage Forms and Strengths

Tablets:

  • 5 mg metoclopramide: green, elliptical-shaped, debossed “REGLAN” over “5” on one side and “ANI” on the opposite side
  • 10 mg metoclopramide: white, double edge scored, capsule-shaped, debossed “REGLAN” on one side and “ANI 10” on the opposite side
How Supplied

Each green, elliptical-shaped Reglan tablet contains 5 mg metoclopramide. The tablet is debossed “REGLAN” over “5” on one side and “ANI” on the opposite side. Available in bottles of 100 tablets (NDC 62559-165-01).

Each white, double edge scored, capsule-shaped Reglan tablet contains 10 mg metoclopramide. The tablet is debossed “REGLAN” on one side and “ANI 10” on the opposite side. Available in bottles of 100 tablets (NDC 62559-166-01).

Manufactured by: ANI Pharmaceuticals, Inc., Baudette, MN 56623

Drugs

Drug Countries
REGLAN Albania, Croatia, United States, South Africa
 
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