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FDA Approval

Glyburide and Metformin Hydrochloride

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Aurobindo Pharma Limited
DUNS: 650082092
Effective Date
March 14, 2022
Labeling Type
Human Prescription Drug Label
Glyburide(2.5 mg in 1 1)
Metformin(500 mg in 1 1)

Manufacturing Establishments1

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

Aurobindo Pharma Limited

Aurobindo Pharma Limited

918917642

Products3

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

Glyburide and Metformin Hydrochloride

Product Details

NDC Product Code
65862-081
Application Number
ANDA077870
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
March 16, 2022
GlyburideActive
Code: SX6K58TVWCClass: ACTIBQuantity: 2.5 mg in 1 1
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
POVIDONE K90Inactive
Code: RDH86HJV5ZClass: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8HClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOAClass: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8Class: IACT
MetforminActive
Code: 786Z46389EClass: ACTIBQuantity: 500 mg in 1 1
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6Class: IACT

Glyburide and Metformin Hydrochloride

Product Details

NDC Product Code
65862-082
Application Number
ANDA077870
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
March 16, 2022
MetforminActive
Code: 786Z46389EClass: ACTIBQuantity: 500 mg in 1 1
GlyburideActive
Code: SX6K58TVWCClass: ACTIBQuantity: 5 mg in 1 1
POVIDONE K90Inactive
Code: RDH86HJV5ZClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6Class: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8HClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3GClass: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8Class: IACT

Glyburide and Metformin Hydrochloride

Product Details

NDC Product Code
65862-080
Application Number
ANDA077870
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
March 16, 2022
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8Class: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6Class: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8HClass: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3GClass: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
POVIDONE K90Inactive
Code: RDH86HJV5ZClass: IACT
GlyburideActive
Code: SX6K58TVWCClass: ACTIBQuantity: 1.25 mg in 1 1
MetforminActive
Code: 786Z46389EClass: ACTIBQuantity: 250 mg in 1 1
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
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