Lopinavir and Ritonavir
These highlights do not include all the information needed to use LOPINAVIR AND RITONAVIR TABLETS safely and effectively. See full prescribing information for LOPINAVIR AND RITONAVIR TABLETS. LOPINAVIR AND RITONAVIR tablets, for oral use Initial U.S. Approval: 2000
Approved
Approval ID
f63db7e1-71cd-325c-e053-2995a90aa071
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 6, 2023
Manufacturers
FDA
NuCare Pharmaceuticals,Inc.
DUNS: 010632300
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Lopinavir and Ritonavir
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68071-2949
Application NumberANDA213857
Product Classification
M
Marketing Category
C73584
G
Generic Name
Lopinavir and Ritonavir
Product Specifications
Route of AdministrationORAL
Effective DateMarch 6, 2023
FDA Product Classification
INGREDIENTS (15)
COPOVIDONEInactive
Code: D9C330MD8B
Classification: IACT
SORBITAN MONOLAURATEInactive
Code: 6W9PS8B71J
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
POLYETHYLENE GLYCOL 3350Inactive
Code: G2M7P15E5P
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 9XZ8H6N6OH
Classification: IACT
LOPINAVIRActive
Quantity: 200 mg in 1 1
Code: 2494G1JF75
Classification: ACTIB
HYPROMELLOSE 2910 (15 MPA.S)Inactive
Code: 36SFW2JZ0W
Classification: IACT
RITONAVIRActive
Quantity: 50 mg in 1 1
Code: O3J8G9O825
Classification: ACTIB