Glyburide-Metformin Hydrochloride

Registrants1

Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.

Blenheim Pharmacal, Inc.

DUNS Number

171434587

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

Blenheim Pharmacal, Inc.

Labeler

Blenheim Pharmacal, Inc.

Registrant

Blenheim Pharmacal, Inc.

DUNS Number

171434587

Products2

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Product Details

NDC Product Code

10544-580

Application Number

ANDA079009

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

February 18, 2015

Ingredients

SODIUM STARCH GLYCOLATE TYPE A POTATOInactive

Code: 5856J3G2A2Class: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

HYPROMELLOSE 2910 (15 MPA.S)Inactive

Code: 36SFW2JZ0WClass: IACT

POVIDONEInactive

Code: FZ989GH94EClass: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

POLYETHYLENE GLYCOL 6000Inactive

Code: 30IQX730WEClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

PROPYLENE GLYCOL, (R)-Inactive

Code: 602HN5L69HClass: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRTClass: IACT

GlyburideActive

Code: SX6K58TVWCClass: ACTIBQuantity: 2.5 mg in 1 1

FERRIC OXIDE REDInactive

Code: 1K09F3G675Class: IACT

MetforminActive

Code: 786Z46389EClass: ACTIBQuantity: 500 mg in 1 1