Glyburide-Metformin Hydrochloride
Rx only
Approved
Approval ID
0f530fcd-0ac0-3885-e054-00144ff88e88
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 18, 2015
Manufacturers
FDA
Blenheim Pharmacal, Inc.
DUNS: 171434587
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Glyburide-Metformin Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code10544-580
Application NumberANDA079009
Product Classification
M
Marketing Category
C73584
G
Generic Name
Glyburide-Metformin Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 18, 2015
FDA Product Classification
INGREDIENTS (13)
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
HYPROMELLOSE 2910 (15 MPA.S)Inactive
Code: 36SFW2JZ0W
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOL 6000Inactive
Code: 30IQX730WE
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
PROPYLENE GLYCOL, (R)-Inactive
Code: 602HN5L69H
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
GLYBURIDEActive
Quantity: 2.5 mg in 1 1
Code: SX6K58TVWC
Classification: ACTIB
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
METFORMIN HYDROCHLORIDEActive
Quantity: 500 mg in 1 1
Code: 786Z46389E
Classification: ACTIB
Glyburide-Metformin Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code10544-579
Application NumberANDA079009
Product Classification
M
Marketing Category
C73584
G
Generic Name
Glyburide-Metformin Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 18, 2015
FDA Product Classification
INGREDIENTS (13)
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
GLYBURIDEActive
Quantity: 5 mg in 1 1
Code: SX6K58TVWC
Classification: ACTIB
METFORMIN HYDROCHLORIDEActive
Quantity: 500 mg in 1 1
Code: 786Z46389E
Classification: ACTIB
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSE 2910 (15 MPA.S)Inactive
Code: 36SFW2JZ0W
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYETHYLENE GLYCOL 6000Inactive
Code: 30IQX730WE
Classification: IACT
PROPYLENE GLYCOL, (R)-Inactive
Code: 602HN5L69H
Classification: IACT