NDC Code(s) : 50090-5246-0, 50090-5246-1, 50090-5246-2, 50090-5246-3
Packager : A-S Medication Solutions

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 Label Item Code (Source) NDC:50090-5246(NDC:67877-414)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
METFORMIN HYDROCHLORIDE(UNII: 786Z46389E)
(METFORMIN - UNII:9100L32L2N) 		METFORMIN HYDROCHLORIDE750 mg
Inactive Ingredients
Ingredient Name Strength
MAGNESIUM STEARATE(UNII: 70097M6I30)
HYPROMELLOSE 2208 (100000 MPA.S)(UNII: VM7F0B23ZI)
COPOVIDONE K25-31(UNII: D9C330MD8B)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM(UNII: K679OBS311)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
Product Characteristics
Color WHITE (white to off white) Score no score
Shape OVAL (capsule shaped tablets) Size 21 mm
Flavor Imprint Code MX;750
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:50090-5246-090 in 1 BOTTLE Type 0: Not a Combination Product10/12/2020
2NDC:50090-5246-160 in 1 BOTTLE Type 0: Not a Combination Product10/12/2020
3NDC:50090-5246-2100 in 1 BOTTLE Type 0: Not a Combination Product13/03/2023
4NDC:50090-5246-330 in 1 BOTTLE Type 0: Not a Combination Product08/04/2023
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA206145 10/27/2018

LABELER - A-S Medication Solutions(830016429)

Establishment
Name Address ID/FEI Business Operations
A-S Medication Solutions 830016429 RELABEL(50090-5246), REPACK(50090-5246)

PRINCIPAL DISPLAY PANEL

Label Image