NDC Code(s) : 13668-012-90, 13668-012-60, 13668-012-30, 13668-012-05, 13668-012-12, 13668-013-90, 13668-013-12, 13668-013-05, 13668-013-30, 13668-013-60
Packager : Torrent Pharmaceuticals Limited

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Metformin HydrochlorideMetformin Hydrochloride TABLET, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:13668-012
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
Product Characteristics
Color WHITE (white to off-white) Score no score
Shape CAPSULE (capsule) Size 19 mm
Flavor Imprint Code 500
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:13668-012-9090 in 1 BOTTLE Type 0: Not a Combination Product30/12/2009
2NDC:13668-012-6060 in 1 BOTTLE Type 0: Not a Combination Product30/12/2009
3NDC:13668-012-3030 in 1 BOTTLE Type 0: Not a Combination Product30/12/2009
4NDC:13668-012-05500 in 1 BOTTLE Type 0: Not a Combination Product30/12/2009
5NDC:13668-012-12120 in 1 BOTTLE Type 0: Not a Combination Product30/12/2009
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090014 12/30/2009

INGREDIENTS AND APPEARANCE

Metformin Hydrochloridemetformin hydrochloride TABLET, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:13668-013
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
METFORMIN HYDROCHLORIDE(UNII: 786Z46389E)
(METFORMIN - UNII:9100L32L2N) 		METFORMIN HYDROCHLORIDE750 mg
Inactive Ingredients
Ingredient Name Strength
DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMER(UNII: 905HNO1SIH)
HYDROGENATED CASTOR OIL(UNII: ZF94AP8MEY)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
FERRIC OXIDE RED(UNII: 1K09F3G675)
Product Characteristics
Color RED (pale red colored) Score no score
Shape CAPSULE (capsule) Size 19 mm
Flavor Imprint Code 750
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:13668-013-9090 in 1 BOTTLE Type 0: Not a Combination Product18/02/2010
2NDC:13668-013-12120 in 1 BOTTLE Type 0: Not a Combination Product18/02/2010
3NDC:13668-013-05500 in 1 BOTTLE Type 0: Not a Combination Product18/02/2010
4NDC:13668-013-3030 in 1 BOTTLE Type 0: Not a Combination Product18/02/2010
5NDC:13668-013-6060 in 1 BOTTLE Type 0: Not a Combination Product18/02/2010
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA079226 02/18/2010

PRINCIPAL DISPLAY PANEL

500 mg  : label

Label

PRINCIPAL DISPLAY PANEL

750 mg  : label

Label