NDC Code(s) : 50228-105-30, 50228-105-01, 50228-105-05, 50228-105-10, 50228-105-00, 50228-106-30, 50228-106-01, 50228-106-05, 50228-106-10, 50228-106-00, 50228-107-30, 50228-107-60, 50228-107-01, 50228-107-05, 50228-107-10, 50228-107-00
Packager : ScieGen Pharmaceuticals 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:50228-105
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
STARCH, CORN(UNII: O8232NY3SJ)
POVIDONE, UNSPECIFIED(UNII: FZ989GH94E)
CROSPOVIDONE, UNSPECIFIED(UNII: 2S7830E561)
MAGNESIUM STEARATE(UNII: 70097M6I30)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
DEXTROSE, UNSPECIFIED FORM(UNII: IY9XDZ35W2)
ALCOHOL(UNII: 3K9958V90M)
ACACIA(UNII: 5C5403N26O)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
Product Characteristics
Color white (off-white) Score no score
Shape ROUND Size 11 mm
Flavor BLACKBERRY Imprint Code SG;105
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:50228-105-3030 in 1 BOTTLE Type 0: Not a Combination Product02/01/2015
2NDC:50228-105-01100 in 1 BOTTLE Type 0: Not a Combination Product02/01/2015
3NDC:50228-105-05500 in 1 BOTTLE Type 0: Not a Combination Product02/01/2015
4NDC:50228-105-101000 in 1 BOTTLE Type 0: Not a Combination Product02/01/2015
5NDC:50228-105-009000 in 1 BOTTLE Type 0: Not a Combination Product02/01/2015
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA203769 02/01/2015
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDE TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50228-106
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
STARCH, CORN(UNII: O8232NY3SJ)
POVIDONE, UNSPECIFIED(UNII: FZ989GH94E)
CROSPOVIDONE, UNSPECIFIED(UNII: 2S7830E561)
MAGNESIUM STEARATE(UNII: 70097M6I30)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
DEXTROSE, UNSPECIFIED FORM(UNII: IY9XDZ35W2)
ALCOHOL(UNII: 3K9958V90M)
ACACIA(UNII: 5C5403N26O)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
Product Characteristics
Color white (off-white) Score no score
Shape ROUND Size 13 mm
Flavor BLACKBERRY Imprint Code SG;106
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:50228-106-3030 in 1 BOTTLE Type 0: Not a Combination Product02/01/2015
2NDC:50228-106-01100 in 1 BOTTLE Type 0: Not a Combination Product02/01/2015
3NDC:50228-106-05500 in 1 BOTTLE Type 0: Not a Combination Product02/01/2015
4NDC:50228-106-101000 in 1 BOTTLE Type 0: Not a Combination Product02/01/2015
5NDC:50228-106-004200 in 1 BOTTLE Type 0: Not a Combination Product02/01/2015
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA203769 02/01/2015
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDE TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50228-107
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
STARCH, CORN(UNII: O8232NY3SJ)
POVIDONE, UNSPECIFIED(UNII: FZ989GH94E)
CROSPOVIDONE, UNSPECIFIED(UNII: 2S7830E561)
MAGNESIUM STEARATE(UNII: 70097M6I30)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
DEXTROSE, UNSPECIFIED FORM(UNII: IY9XDZ35W2)
ALCOHOL(UNII: 3K9958V90M)
ACACIA(UNII: 5C5403N26O)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
Product Characteristics
Color white (off-white) Score 2 pieces
Shape OVAL Size 19 mm
Flavor BLACKBERRY Imprint Code S;G;1;07
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:50228-107-3030 in 1 BOTTLE Type 0: Not a Combination Product02/01/2015
2NDC:50228-107-6060 in 1 BOTTLE Type 0: Not a Combination Product26/12/2022
3NDC:50228-107-01100 in 1 BOTTLE Type 0: Not a Combination Product02/01/2015
4NDC:50228-107-05500 in 1 BOTTLE Type 0: Not a Combination Product02/01/2015
5NDC:50228-107-101000 in 1 BOTTLE Type 0: Not a Combination Product02/01/2015
6NDC:50228-107-00100 in 1 BOTTLE Type 0: Not a Combination Product02/01/2015
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA203769 02/01/2015

LABELER - ScieGen Pharmaceuticals Inc(079391286)

Establishment
Name Address ID/FEI Business Operations
ScieGen Pharmaceuticals Inc 079391286 manufacture(50228-105, 50228-106, 50228-107), analysis(50228-105, 50228-106, 50228-107)

PRINCIPAL DISPLAY PANEL

NDC 50228-105-01

Metformin Hydrochloride

Tablets, USP

500 mg

100 Tablets R x Only

ScieGen

Pharmaceuticals Inc.

500mg-01

NDC 50228-105-05

Metformin Hydrochloride

Tablets, USP

500 mg

500 Tablets R x Only

ScieGen

Pharmaceuticals Inc.

500mg-01

NDC 50228-105-10

Metformin Hydrochloride

Tablets, USP

500 mg

1,000 Tablets R x Only

ScieGen

Pharmaceuticals Inc.

500mg-01

NDC 50228-106-01

Metformin Hydrochloride

Tablets, USP

850 mg

100 Tablets R x Only

ScieGen

Pharmaceuticals Inc.

500mg-01

NDC 50228-106-05

Metformin Hydrochloride

Tablets, USP

850 mg

500 Tablets R x Only

ScieGen

Pharmaceuticals Inc.

500mg-01

NDC 50228-106-10

Metformin Hydrochloride

Tablets, USP

850 mg

1,000 Tablets R x Only

ScieGen

Pharmaceuticals Inc.

500mg-01

NDC 50228-107-60

Metformin Hydrochloride

Tablets, USP

1000 mg

60 Tablets R x Only

ScieGen
Pharmaceuticals Inc.

500mg-01

NDC 50228-107-01

Metformin Hydrochloride

Tablets, USP

1000 mg

100 Tablets R x Only

ScieGen

Pharmaceuticals Inc.

500mg-01

NDC 50228-107-05

Metformin Hydrochloride

Tablets, USP

1000 mg

500 Tablets R x Only

ScieGen

Pharmaceuticals Inc.

500mg-01

NDC 50228-107-10

Metformin Hydrochloride

Tablets, USP

1000 mg

1,000 Tablets R x Only

ScieGen

Pharmaceuticals Inc.

500mg-01