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
b670a844-3bbf-4d9a-9904-87992f26792d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 25, 2023
Manufacturers
FDA
Amneal Pharmaceuticals NY LLC
DUNS: 123797875
Products 4
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 Code69238-1138
Application NumberANDA209717
Product Classification
M
Marketing Category
C73584
G
Generic Name
Atazanavir
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 25, 2023
FDA Product Classification
INGREDIENTS (16)
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
ATAZANAVIR SULFATEActive
Quantity: 300 mg in 1 1
Code: 4MT4VIE29P
Classification: ACTIM
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
Atazanavir
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69238-1136
Application NumberANDA209717
Product Classification
M
Marketing Category
C73584
G
Generic Name
Atazanavir
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 25, 2023
FDA Product Classification
INGREDIENTS (16)
ATAZANAVIR SULFATEActive
Quantity: 150 mg in 1 1
Code: 4MT4VIE29P
Classification: ACTIM
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
FD&C RED NO. 3Inactive
Code: PN2ZH5LOQY
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
Atazanavir
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69238-1137
Application NumberANDA209717
Product Classification
M
Marketing Category
C73584
G
Generic Name
Atazanavir
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 25, 2023
FDA Product Classification
INGREDIENTS (14)
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
ATAZANAVIR SULFATEActive
Quantity: 200 mg in 1 1
Code: 4MT4VIE29P
Classification: ACTIM
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
Atazanavir
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69238-1135
Application NumberANDA209717
Product Classification
M
Marketing Category
C73584
G
Generic Name
Atazanavir
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 25, 2023
FDA Product Classification
INGREDIENTS (15)
ATAZANAVIR SULFATEActive
Quantity: 100 mg in 1 1
Code: 4MT4VIE29P
Classification: ACTIM
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT