NDC 58118-7212-0
API & Excipient Details

Metformin marketed by Clinical Solutions Wholesale under NDC Code 58118-7212-0

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
METFORMIN HYDROCHLORIDE(UNII: 786Z46389E) (METFORMIN - UNII:9100L32L2N)	METFORMIN HYDROCHLORIDE	750 mg

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:58118-7212-9	90 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product	04/07/2013
2	NDC:58118-7212-3	30 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product	04/07/2013
3	NDC:58118-7212-8	30 in 1 BLISTER PACK Type 0: Not a Combination Product	04/07/2013
4	NDC:58118-7212-0	1 in 1 PACKAGE Type 0: Not a Combination Product	04/07/2013

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA076864	04/13/2005	06/15/2017

PRINCIPAL DISPLAY PANEL