Norvir
These highlights do not include all the information needed to use NORVIR safely and effectively. See full prescribing information for NORVIR. NORVIR (ritonavir) tablets, for oral use NORVIR (ritonavir) oral solution NORVIR (ritonavir) oral powder Initial U.S. Approval: 1996
Approved
Approval ID
2849298e-de6e-47bb-8194-56e075b33fc3
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 15, 2022
Manufacturers
FDA
AbbVie Inc.
DUNS: 078458370
Products 4
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Ritonavir
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0074-2340
Application NumberNDA022417
Product Classification
M
Marketing Category
C73594
G
Generic Name
Ritonavir
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 27, 2023
FDA Product Classification
INGREDIENTS (13)
RITONAVIRActive
Quantity: 100 mg in 1 1
Code: O3J8G9O825
Classification: ACTIB
COPOVIDONE K25-31Inactive
Code: D9C330MD8B
Classification: IACT
SORBITAN MONOLAURATEInactive
Code: 6W9PS8B71J
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92J
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 9XZ8H6N6OH
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
POLYETHYLENE GLYCOL 3350Inactive
Code: G2M7P15E5P
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
Ritonavir
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0074-1940
Application NumberNDA020659
Product Classification
M
Marketing Category
C73594
G
Generic Name
Ritonavir
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 27, 2023
FDA Product Classification
INGREDIENTS (10)
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
RITONAVIRActive
Quantity: 80 mg in 1 mL
Code: O3J8G9O825
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
POLYOXYL 35 CASTOR OILInactive
Code: 6D4M1DAL6O
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
PEPPERMINT OILInactive
Code: AV092KU4JH
Classification: IACT
CARAMELInactive
Code: T9D99G2B1R
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
Ritonavir
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0074-3399
Application NumberNDA209512
Product Classification
M
Marketing Category
C73594
G
Generic Name
Ritonavir
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 27, 2023
FDA Product Classification
INGREDIENTS (4)
COPOVIDONE K25-31Inactive
Code: D9C330MD8B
Classification: IACT
SORBITAN MONOLAURATEInactive
Code: 6W9PS8B71J
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
RITONAVIRActive
Quantity: 100 mg in 1 1
Code: O3J8G9O825
Classification: ACTIB
Ritonavir
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0074-3333
Application NumberNDA022417
Product Classification
M
Marketing Category
C73594
G
Generic Name
Ritonavir
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 27, 2023
FDA Product Classification
INGREDIENTS (13)
RITONAVIRActive
Quantity: 100 mg in 1 1
Code: O3J8G9O825
Classification: ACTIB
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
COPOVIDONE K25-31Inactive
Code: D9C330MD8B
Classification: IACT
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92J
Classification: IACT
SORBITAN MONOLAURATEInactive
Code: 6W9PS8B71J
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 9XZ8H6N6OH
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
POLYETHYLENE GLYCOL 3350Inactive
Code: G2M7P15E5P
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT