FDA Product

REGLAN

Product approved by U.S. Food and Drug Administration (US)

Basic Information

Product Name

REGLAN

FDA Product Code

16590-906

Regulatory Information

NDC Product Code

16590-906

Application Number

NDA017854

Marketing Category

C73594

Effective Date

August 31, 2010

Territorial Authority

USA

FDA Title

reglan tablets (metoclopramide tablets, USP)

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

1

Company Information

ManufacturerSTAT RX USA LLC

DUNS Number

786036330

Active Ingredients

METOCLOPRAMIDE HYDROCHLORIDE

Quantity: 10 mg in 1 1

Code: W1792A2RVD

Class Code: ACTIB

CELLULOSE, MICROCRYSTALLINE

Code: OP1R32D61U

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

MANNITOL

Code: 3OWL53L36A

Class Code: IACT

STEARIC ACID

Code: 4ELV7Z65AP

Class Code: IACT

Active Moieties

METOCLOPRAMIDE

Code: L4YEB44I46

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