REGLAN (Page 5 of 5)

PACKAGE LABEL

REGLAN 10MG LABEL IMAGE

REGLAN 10MG LABEL IMAGE
(click image for full-size original)
REGLAN metoclopramide hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:16590-906(NDC:68220-151)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
METOCLOPRAMIDE HYDROCHLORIDE (METOCLOPRAMIDE) METOCLOPRAMIDE HYDROCHLORIDE 10 mg
Inactive Ingredients
Ingredient Name Strength
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
MANNITOL
STEARIC ACID
Product Characteristics
Color white Score 2 pieces
Shape OVAL Size 11mm
Flavor Imprint Code REGLAN;AP;10
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:16590-906-30 30 TABLET (TABLET) in 1 BOTTLE None
2 NDC:16590-906-60 60 TABLET (TABLET) in 1 BOTTLE None
3 NDC:16590-906-90 90 TABLET (TABLET) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA017854 01/15/2010
Labeler — STAT RX USA LLC (786036330)
Establishment
Name Address ID/FEI Operations
STAT RX USA LLC 786036330 repack, relabel

Revised: 08/2010 STAT RX USA LLC

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