Efavirenz
These highlights do not include all the information needed to use EFAVIRENZ TABLETS safely and effectively. See full prescribing information for EFAVIRENZ TABLETS. EFAVIRENZ tablets, for oral use Initial U.S. Approval: 1998
Approved
Approval ID
c5eedb5d-4cab-4056-a14a-ffdf67701355
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 29, 2023
Manufacturers
FDA
Aurobindo Pharma Limited
DUNS: 650082092
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Efavirenz
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code65862-049
Application NumberANDA077673
Product Classification
M
Marketing Category
C73584
G
Generic Name
Efavirenz
Product Specifications
Route of AdministrationORAL
Effective DateDecember 29, 2023
FDA Product Classification
INGREDIENTS (11)
EFAVIRENZActive
Quantity: 600 mg in 1 1
Code: JE6H2O27P8
Classification: ACTIB
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 9XZ8H6N6OH
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT