Metformin Hydrochloride (Page 7 of 7)

PRINCIPAL DISPLAY PANEL

NDC 50228-445 -30
Metformin Hydrochloride
Extended-Release
Tablets, USP
500 mg
ONCE DAILY
30 Tablets Rx only
ScieGen Pharmaceuticals Inc.

500mg label
(click image for full-size original)

NDC 50228-445 -05
Metformin Hydrochloride
Extended-Release
Tablets, USP
500 mg
ONCE DAILY
500 Tablets Rx only
ScieGen Pharmaceuticals Inc.

500mg label
(click image for full-size original)

NDC 50228-445-01
Metformin Hydrochloride
Extended-Release
Tablets, USP
500 mg
ONCE DAILY
100 Tablets Rx Only
ScieGen Pharmaceuticals Inc.

500mg label
(click image for full-size original)

NDC 50228-446 -30
Metformin Hydrochloride
Extended-Release
Tablets, USP
1,000 mg
ONCE DAILY
30 Tablets Rx only
ScieGen Pharmaceuticals Inc.

1000mg label
(click image for full-size original)

NDC 50228-446 -05
Metformin Hydrochloride
Extended-Release
Tablets, USP
1,000 mg
ONCE DAILY
500 Tablets Rx only
ScieGen Pharmaceuticals Inc.

1000mg label
(click image for full-size original)

NDC 50228-446-90
Metformin Hydrochloride
Extended-Release
Tablets, USP
1,000 mg
ONCE DAILY
90 Tablets Rx Only
ScieGen Pharmaceuticals Inc.

1000mg label
(click image for full-size original)
METFORMIN HYDROCHLORIDE metformin hydrochloride extended-release tablets tablet, film coated, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50228-445
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
METFORMIN HYDROCHLORIDE (METFORMIN) METFORMIN HYDROCHLORIDE 500 mg
Inactive Ingredients
Ingredient Name Strength
AMMONIO METHACRYLATE COPOLYMER TYPE A
CROSPOVIDONE
HYPROMELLOSE, UNSPECIFIED
MAGNESIUM STEARATE
STARCH, CORN
POVIDONE
POLYETHYLENE GLYCOL, UNSPECIFIED
SILICON DIOXIDE
TALC
TITANIUM DIOXIDE
TRIETHYL CITRATE
Product Characteristics
Color white (White to off white) Score no score
Shape OVAL Size 16mm
Flavor Imprint Code 445
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50228-445-30 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC None
2 NDC:50228-445-05 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC None
3 NDC:50228-445-01 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA213334 04/16/2021
METFORMIN HYDROCHLORIDE metformin hydrochloride extended-release tablets tablet, film coated, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50228-446
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
METFORMIN HYDROCHLORIDE (METFORMIN) METFORMIN HYDROCHLORIDE 1000 mg
Inactive Ingredients
Ingredient Name Strength
AMMONIO METHACRYLATE COPOLYMER TYPE A
CROSPOVIDONE
HYPROMELLOSE, UNSPECIFIED
MAGNESIUM STEARATE
STARCH, CORN
POVIDONE
POLYETHYLENE GLYCOL, UNSPECIFIED
SILICON DIOXIDE
TALC
TITANIUM DIOXIDE
TRIETHYL CITRATE
Product Characteristics
Color white (White to off white) Score no score
Shape OVAL Size 20mm
Flavor Imprint Code 446
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50228-446-30 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC None
2 NDC:50228-446-05 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC None
3 NDC:50228-446-90 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA213334 04/16/2021
Labeler — ScieGen Pharmaceuticals, Inc. (079391286)
Establishment
Name Address ID/FEI Operations
ScieGen Pharmaceuticals, Inc. 079391286 analysis (50228-445), analysis (50228-446), manufacture (50228-445), manufacture (50228-446)

Revised: 06/2021 ScieGen Pharmaceuticals, Inc.

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