Metformin Hydrochloride (Page 7 of 7)

PRINCIPAL DISPLAY PANEL

NDC 11788- 037 -60

Metformin Hydrochloride

Extended-Release Tablets

500mg

Rx only 60 Tablets

PRINCIPAL DISPLAY PANEL

NDC 11788- 038 -60

Metformin Hydrochloride

Extended-Release Tablets

1000mg

Rx only 60 Tablets

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.