NDC Code(s) : 0904-6343-14, 0904-6343-18, 0904-6343-25, 0904-6343-40, 0904-6343-52, 0904-6343-53, 0904-6343-54, 0904-6343-60, 0904-6343-80, 0904-6343-89, 0904-6343-93, 0904-6344-40, 0904-6344-52, 0904-6344-53, 0904-6344-89, 0904-6344-93, 0904-6345-40, 0904-6345-52, 0904-6345-89, 0904-6345-93
Packager : Major Pharmaceuticals

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:0904-6343(NDC:0185-0213)
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
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
MAGNESIUM STEARATE(UNII: 70097M6I30)
POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
POVIDONE K12(UNII: 333AG72FWJ)
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 12 mm
Flavor Imprint Code E;213
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0904-6343-14360 in 1 BOTTLE Type 0: Not a Combination Product03/02/2014
2NDC:0904-6343-18120 in 1 BOTTLE Type 0: Not a Combination Product03/02/2014
3NDC:0904-6343-25200 in 1 BOTTLE Type 0: Not a Combination Product03/02/2014
4NDC:0904-6343-40500 in 1 BOTTLE Type 0: Not a Combination Product03/02/2014
5NDC:0904-6343-5260 in 1 BOTTLE Type 0: Not a Combination Product03/02/2014
6NDC:0904-6343-53270 in 1 BOTTLE Type 0: Not a Combination Product03/02/2014
7NDC:0904-6343-54450 in 1 BOTTLE Type 0: Not a Combination Product03/02/2014
8NDC:0904-6343-60100 in 1 BOTTLE Type 0: Not a Combination Product03/02/2014
9NDC:0904-6343-801000 in 1 BOTTLE Type 0: Not a Combination Product03/02/2014
10NDC:0904-6343-8990 in 1 BOTTLE Type 0: Not a Combination Product03/02/2014
11NDC:0904-6343-93180 in 1 BOTTLE Type 0: Not a Combination Product03/02/2014
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075965 02/03/2014
metformin hydrochloridemetformin hydrochloride TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0904-6344(NDC:0185-0215)
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
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
MAGNESIUM STEARATE(UNII: 70097M6I30)
POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
POVIDONE K12(UNII: 333AG72FWJ)
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 14 mm
Flavor Imprint Code E;215
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0904-6344-40500 in 1 BOTTLE Type 0: Not a Combination Product03/02/2014
2NDC:0904-6344-5260 in 1 BOTTLE Type 0: Not a Combination Product03/02/2014
3NDC:0904-6344-53270 in 1 BOTTLE Type 0: Not a Combination Product03/02/2014
4NDC:0904-6344-8990 in 1 BOTTLE Type 0: Not a Combination Product03/02/2014
5NDC:0904-6344-93180 in 1 BOTTLE Type 0: Not a Combination Product03/02/2014
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075965 02/03/2014
metformin hydrochloridemetformin hydrochloride TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0904-6345(NDC:0185-0221)
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
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
MAGNESIUM STEARATE(UNII: 70097M6I30)
POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
POVIDONE K12(UNII: 333AG72FWJ)
Product Characteristics
Color WHITE Score 2 pieces
Shape OVAL Size 19 mm
Flavor Imprint Code E;221
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0904-6345-40500 in 1 BOTTLE Type 0: Not a Combination Product03/02/2014
2NDC:0904-6345-5260 in 1 BOTTLE Type 0: Not a Combination Product03/02/2014
3NDC:0904-6345-8990 in 1 BOTTLE Type 0: Not a Combination Product03/02/2014
4NDC:0904-6345-93180 in 1 BOTTLE Type 0: Not a Combination Product03/02/2014
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075965 02/03/2014

PRINCIPAL DISPLAY PANEL

NDC 0904-6343-52

Metformin Hydrochloride Tablets USP

500 mg

Rx only

60 Tablets

Major Pharmaceuticals

Metformin Hcl 500 mg Tablets USP

PRINCIPAL DISPLAY PANEL

NDC 0904-6344-52

Metformin Hydrochloride Tablets USP

850 mg

Rx only

60 Tablets

Major Pharmaceuticals

Metformin Hcl 850 mg Tablets USP

PRINCIPAL DISPLAY PANEL

NDC 0904-6345-52

Metformin Hydrochloride Tablets USP

1000 mg

Rx only

60 Tablets

Major Pharmaceuticals

Metformin Hcl 1000 mg Tablets USP