NDC Code(s) : 68180-336-07, 68180-336-02, 68180-336-01, 68180-337-07, 68180-337-01, 68180-337-02
Packager : Lupin Pharmaceuticals, Inc.

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:68180-336
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
AMMONIO METHACRYLATE COPOLYMER TYPE A(UNII: 8GQS4E66YY)
AMMONIO METHACRYLATE COPOLYMER TYPE B(UNII: 161H3B14U2)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
DIBUTYL SEBACATE(UNII: 4W5IH7FLNY)
HYPROMELLOSES(UNII: 3NXW29V3WO)
MAGNESIUM STEARATE(UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
POVIDONE(UNII: FZ989GH94E)
CROSPOVIDONE(UNII: 2S7830E561)
Product Characteristics
Color WHITE (white to off white) Score no score
Shape OVAL (OVAL) Size 18 mm
Flavor Imprint Code Q21;LU
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:68180-336-0760 in 1 BOTTLE Type 0: Not a Combination Product30/09/2011
2NDC:68180-336-02500 in 1 BOTTLE Type 0: Not a Combination Product01/01/2040
3NDC:68180-336-01100 in 1 BOTTLE Type 0: Not a Combination Product01/01/2040
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090692 09/30/2011
Metformin HydrochlorideMetformin Hydrochloride TABLET, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68180-337
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
METFORMIN HYDROCHLORIDE(UNII: 786Z46389E)
(METFORMIN - UNII:9100L32L2N) 		METFORMIN HYDROCHLORIDE1000 mg
Inactive Ingredients
Ingredient Name Strength
AMMONIO METHACRYLATE COPOLYMER TYPE A(UNII: 8GQS4E66YY)
AMMONIO METHACRYLATE COPOLYMER TYPE B(UNII: 161H3B14U2)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
DIBUTYL SEBACATE(UNII: 4W5IH7FLNY)
HYPROMELLOSES(UNII: 3NXW29V3WO)
MAGNESIUM STEARATE(UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
POVIDONE(UNII: FZ989GH94E)
CROSPOVIDONE(UNII: 2S7830E561)
Product Characteristics
Color WHITE (white to off white) Score no score
Shape OVAL (OVAL) Size 21 mm
Flavor Imprint Code Q22;LU
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:68180-337-0760 in 1 BOTTLE Type 0: Not a Combination Product30/09/2011
2NDC:68180-337-01100 in 1 BOTTLE Type 0: Not a Combination Product01/01/2040
3NDC:68180-337-02500 in 1 BOTTLE Type 0: Not a Combination Product01/01/2040
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090692 09/30/2011

LABELER - Lupin Pharmaceuticals, Inc.(089153071)

REGISTRANT - LUPIN LIMITED(675923163)

Establishment
Name Address ID/FEI Business Operations
LUPIN LIMITED 677600414 MANUFACTURE(68180-336, 68180-337), PACK(68180-336, 68180-337)

PRINCIPAL DISPLAY PANEL

Metformin Hydrochloride Extended-Release Tablets.

Rx only

500 mg

NDC 68180-336-07

60 Bottles

500 mg

Metformin Hydrochloride Extended-Release Tablets

Rx only

1000 mg

NDC 68180-337-07

60 Bottles

500 mg