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 useInitial U.S. Approval: 1998
Approved
Approval ID
aad2eaf6-86b3-4f23-8962-2c2273bd7e38
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 23, 2023
Manufacturers
FDA
Strides Pharma Inc.
DUNS: 078310501
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Efavirenz
PRODUCT DETAILS
NDC Product Code42543-889
Application NumberANDA204869
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateJanuary 23, 2023
Generic NameEfavirenz
INGREDIENTS (15)
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
HYDROXYPROPYL CELLULOSE (90000 WAMW)Inactive
Code: UKE75GEA7F
Classification: IACT
EFAVIRENZActive
Quantity: 600 mg in 1 1
Code: JE6H2O27P8
Classification: ACTIB
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT