NDC Code(s) : 49349-707-02
Packager : REMEDYREPACK INC.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Metformin Hydrochloride Metformin Hydrochloride TABLET, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49349-707(NDC:62037-571)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
METFORMIN HYDROCHLORIDE(UNII: 786Z46389E)
(METFORMIN - UNII:9100L32L2N) 		METFORMIN HYDROCHLORIDE500 mg
Inactive Ingredients
Ingredient Name Strength
HYPROMELLOSE 2208 (3 MPA.S)(UNII: 9H4L916OBU)
silicon dioxide(UNII: ETJ7Z6XBU4)
magnesium stearate(UNII: 70097M6I30)
Product Characteristics
Color white Score no score
Shape OVAL (TABLET, EXTENDED RELEASE) Size 20 mm
Flavor Imprint Code 571;500
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:49349-707-0230 in 1 BLISTER PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075979 09/08/2011

PRINCIPAL DISPLAY PANEL

DRUG: Metformin Hydrochloride
GENERIC: Metformin Hydrochloride
DOSAGE: TABLET, EXTENDED RELEASE
ADMINSTRATION: ORAL
NDC: 49349-707-02
STRENGTH:500 mg
COLOR: white
SHAPE: OVAL
SCORE: No score
SIZE: 20 mm
IMPRINT: 30
QTY: 30

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