Metformin Hydrochloride (Page 7 of 7)

PRINCIPAL DISPLAY PANEL

NDC 11788- 037 -60

Metformin Hydrochloride

Extended-Release Tablets

500mg

Rx only 60 Tablets

500
(click image for full-size original)

PRINCIPAL DISPLAY PANEL

NDC 11788- 038 -60

Metformin Hydrochloride

Extended-Release Tablets

1000mg

Rx only 60 Tablets

1000
(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:11788-037
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
SODIUM LAURYL SULFATE
POVIDONE
MAGNESIUM STEARATE
CELLULOSE ACETATE
POLYETHYLENE GLYCOL 400
ACETONE
POLYETHYLENE GLYCOL 8000
TRIACETIN
HYPROMELLOSES
TITANIUM DIOXIDE
POLYSORBATE 80
FERROSOFERRIC OXIDE
SHELLAC
Product Characteristics
Color white Score no score
Shape ROUND Size 12mm
Flavor Imprint Code 0019;500
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:11788-037-60 60 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 ANDA209993 09/24/2019
METFORMIN HYDROCHLORIDE metformin hydrochloride extended-release tablets tablet, film coated, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:11788-038
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
SODIUM LAURYL SULFATE
POVIDONE
MAGNESIUM STEARATE
CELLULOSE ACETATE
POLYETHYLENE GLYCOL 400
ACETONE
POLYETHYLENE GLYCOL 8000
TRIACETIN
HYPROMELLOSES
TITANIUM DIOXIDE
POLYSORBATE 80
FERROSOFERRIC OXIDE
SHELLAC
Product Characteristics
Color white Score no score
Shape ROUND Size 13mm
Flavor Imprint Code 0018;1000
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:11788-038-60 60 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 ANDA209993 09/24/2019
Labeler — AiPing Pharmaceutical, Inc. (079674526)
Establishment
Name Address ID/FEI Operations
Qingdao BAHEAL Pharmaceutical Co., Ltd. 546626586 manufacture (11788-037), manufacture (11788-038)

Revised: 01/2022 AiPing Pharmaceutical, Inc.

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