Atazanavir
These highlights do not include all the information needed to use ATAZANAVIR CAPSULES safely and effectively. See full prescribing information for ATAZANAVIR CAPSULES. ATAZANAVIR capsules, for oral use Initial U.S. Approval: 2003
Approved
Approval ID
8a0c609f-e296-4925-a35c-e93a04467655
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 2, 2022
Manufacturers
FDA
Camber Pharmaceuticals, Inc.
DUNS: 826774775
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Atazanavir
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code31722-653
Application NumberANDA212278
Product Classification
M
Marketing Category
C73584
G
Generic Name
Atazanavir
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 2, 2022
FDA Product Classification
INGREDIENTS (13)
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
ATAZANAVIR SULFATEActive
Quantity: 150 mg in 1 1
Code: 4MT4VIE29P
Classification: ACTIM
SHELLACInactive
Code: MB5IUD6JUA
Classification: IACT
Atazanavir
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code31722-655
Application NumberANDA212278
Product Classification
M
Marketing Category
C73584
G
Generic Name
Atazanavir
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 2, 2022
FDA Product Classification
INGREDIENTS (15)
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
FD&C RED NO. 3Inactive
Code: PN2ZH5LOQY
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
SHELLACInactive
Code: MB5IUD6JUA
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
ATAZANAVIR SULFATEActive
Quantity: 300 mg in 1 1
Code: 4MT4VIE29P
Classification: ACTIM
Atazanavir
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code31722-654
Application NumberANDA212278
Product Classification
M
Marketing Category
C73584
G
Generic Name
Atazanavir
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 2, 2022
FDA Product Classification
INGREDIENTS (14)
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
SHELLACInactive
Code: MB5IUD6JUA
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
ATAZANAVIR SULFATEActive
Quantity: 200 mg in 1 1
Code: 4MT4VIE29P
Classification: ACTIM