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 solutionNORVIR (ritonavir) oral powderInitial U.S. Approval: 1996
Approved
Approval ID
bc00d131-afc3-457f-b18f-065775af6f1c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 22, 2019
Manufacturers
FDA
DOH CENTRAL PHARMACY
DUNS: 829348114
Products 1
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 Code53808-1119
Application NumberNDA022417
Product Classification
M
Marketing Category
C73594
G
Generic Name
Ritonavir
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 22, 2019
FDA Product Classification
INGREDIENTS (13)
RITONAVIRActive
Quantity: 100 mg in 1 1
Code: O3J8G9O825
Classification: ACTIB
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92J
Classification: IACT
SORBITAN MONOLAURATEInactive
Code: 6W9PS8B71J
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
POLYETHYLENE GLYCOL 3350Inactive
Code: G2M7P15E5P
Classification: IACT
COPOVIDONE K25-31Inactive
Code: D9C330MD8B
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671P
Classification: IACT