REYATAZ
These highlights do not include all the information needed to use REYATAZ safely and effectively. See full prescribing information for REYATAZ. REYATAZ (atazanavir) capsules, for oral useREYATAZ (atazanavir) oral powderInitial U.S. Approval: 2003
Approved
Approval ID
165cff62-b284-4a27-a65d-9ec8a5bfcdd8
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 7, 2023
Manufacturers
FDA
E.R. Squibb & Sons, L.L.C.
DUNS: 011550092
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 Code0003-3638
Application NumberNDA206352
Product Classification
M
Marketing Category
C73594
G
Generic Name
ATAZANAVIR
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 24, 2020
FDA Product Classification
INGREDIENTS (3)
ASPARTAMEInactive
Code: Z0H242BBR1
Classification: IACT
ATAZANAVIR SULFATEActive
Quantity: 50 mg in 1 1
Code: 4MT4VIE29P
Classification: ACTIM
SUCROSEInactive
Code: C151H8M554
Classification: IACT
ATAZANAVIR
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0003-3631
Application NumberNDA021567
Product Classification
M
Marketing Category
C73594
G
Generic Name
ATAZANAVIR
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 24, 2020
FDA Product Classification
INGREDIENTS (16)
ATAZANAVIR SULFATEActive
Quantity: 200 mg in 1 1
Code: 4MT4VIE29P
Classification: ACTIM
CROSPOVIDONE (120 .MU.M)Inactive
Code: 68401960MK
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
ATAZANAVIR
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0003-3624
Application NumberNDA021567
Product Classification
M
Marketing Category
C73594
G
Generic Name
ATAZANAVIR
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 24, 2020
FDA Product Classification
INGREDIENTS (16)
ATAZANAVIR SULFATEActive
Quantity: 150 mg in 1 1
Code: 4MT4VIE29P
Classification: ACTIM
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
CROSPOVIDONE (120 .MU.M)Inactive
Code: 68401960MK
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
ATAZANAVIR
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0003-3622
Application NumberNDA021567
Product Classification
M
Marketing Category
C73594
G
Generic Name
ATAZANAVIR
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 24, 2020
FDA Product Classification
INGREDIENTS (16)
ATAZANAVIR SULFATEActive
Quantity: 300 mg in 1 1
Code: 4MT4VIE29P
Classification: ACTIM
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
CROSPOVIDONE (120 .MU.M)Inactive
Code: 68401960MK
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT