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
92603fa5-7a2c-4bfb-9a70-aadb4fba952c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 30, 2023
Manufacturers
FDA
Cipla USA Inc.
DUNS: 078719707
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 Code69097-301
Application NumberANDA204766
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateMarch 31, 2023
Generic NameEfavirenz
INGREDIENTS (10)
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
EFAVIRENZActive
Quantity: 600 mg in 1 1
Code: JE6H2O27P8
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92J
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT