NDC Code(s) : 52125-207-02
Packager : REMEDYREPACK INC.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Metformin HydrochlorideMetformin Hydrochloride TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:52125-207(NDC:68462-160)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
METFORMIN HYDROCHLORIDE(UNII: 786Z46389E)
(METFORMIN - UNII:9100L32L2N) 		METFORMIN HYDROCHLORIDE850 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
MAGNESIUM STEARATE(UNII: 70097M6I30)
POVIDONE K12(UNII: 333AG72FWJ)
POLYETHYLENE GLYCOL 4000000(UNII: RU64142H6P)
POLYETHYLENE GLYCOL 600000(UNII: 2126FD486L)
HYPROMELLOSES(UNII: 3NXW29V3WO)
Product Characteristics
Color white Score no score
Shape ROUND (TABLET) Size 13 mm
Flavor Imprint Code G;45;850
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:52125-207-0290 in 1 BLISTER PACK Type 0: Not a Combination Product23/08/2012
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078170 08/23/2012 01/25/2017

PRINCIPAL DISPLAY PANEL

MM6