NDC Code(s) : 58118-7212-9, 58118-7212-3, 58118-7212-8, 58118-7212-0
Packager : Clinical Solutions Wholesale

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Metformin HydrochlorideMetformin Hydrochloride TABLET, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:58118-7212(NDC:0093-7212)
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
ETHYLCELLULOSE (7 MPA.S)(UNII: H3UP11403C)
HYPROMELLOSE 2208 (100000 MPA.S)(UNII: VM7F0B23ZI)
MAGNESIUM STEARATE(UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
FERRIC OXIDE RED(UNII: 1K09F3G675)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
Product Characteristics
Color red (brick red mottled) Score no score
Shape OVAL Size 19 mm
Flavor Imprint Code 93;7212
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:58118-7212-990 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product04/07/2013
2NDC:58118-7212-330 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product04/07/2013
3NDC:58118-7212-830 in 1 BLISTER PACK Type 0: Not a Combination Product04/07/2013
4NDC:58118-7212-01 in 1 PACKAGE Type 0: Not a Combination Product04/07/2013
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076864 04/13/2005 06/15/2017

PRINCIPAL DISPLAY PANEL

Metformin Hydrochloride ER Tablets USP 750 mg LabelMetformin Hydrochloride ER Tablets USP 750 mg LabelMetformin Hydrochloride ER Tablets USP 750 mg LabelMetformin Hydrochloride ER Tablets USP 750 mg Label