NDC Code(s) : 71610-457-30, 71610-457-53, 71610-457-60, 71610-457-70, 71610-457-80, 71610-457-92, 71610-457-94
Packager : Aphena Pharma Solutions - Tennessee, LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

METFORMIN HYDROCHLORIDE metformin hydrochloride TABLET, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:71610-457(NDC:75834-500)
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
CARBOXYMETHYLCELLULOSE SODIUM(UNII: K679OBS311)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
MAGNESIUM STEARATE(UNII: 70097M6I30)
Product Characteristics
Color white (White to off-white) Score no score
Shape CAPSULE (biconvex, beveled edge) Size 18 mm
Flavor Imprint Code IL001
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:71610-457-3030 in 1 BOTTLE Type 0: Not a Combination Product09/11/2020
2NDC:71610-457-5360 in 1 BOTTLE Type 0: Not a Combination Product09/02/2020
3NDC:71610-457-6090 in 1 BOTTLE Type 0: Not a Combination Product27/08/2020
4NDC:71610-457-70120 in 1 BOTTLE Type 0: Not a Combination Product27/08/2020
5NDC:71610-457-80180 in 1 BOTTLE Type 0: Not a Combination Product27/08/2020
6NDC:71610-457-92270 in 1 BOTTLE Type 0: Not a Combination Product27/08/2020
7NDC:71610-457-94360 in 1 BOTTLE Type 0: Not a Combination Product09/11/2020
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA201991 11/01/2013

LABELER - Aphena Pharma Solutions - Tennessee, LLC(128385585)

Establishment
Name Address ID/FEI Business Operations
Aphena Pharma Solutions - Tennessee, LLC 128385585 REPACK(71610-457)

PRINCIPAL DISPLAY PANEL

NDC 71610-457 - Metformin HCl ER, USP 500 mg Tablets - Rx Only
Bottle Label 500 mg