SUSTIVA
These highlights do not include all the information needed to use SUSTIVA safely and effectively. See full prescribing information for SUSTIVA. SUSTIVA (efavirenz) capsules for oral useSUSTIVA (efavirenz) tablets for oral useInitial U.S. Approval: 1998
Approved
Approval ID
04b5c345-c446-43a4-83f0-509bc287e10b
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 2, 2013
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
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 Code54868-4668
Application NumberNDA021360
Product Classification
M
Marketing Category
C73594
G
Generic Name
efavirenz
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 2, 2013
FDA Product Classification
INGREDIENTS (8)
efavirenzActive
Quantity: 600 mg in 1 1
Code: JE6H2O27P8
Classification: ACTIB
hydroxypropyl celluloseInactive
Code: RFW2ET671P
Classification: IACT
lactose monohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT
sodium lauryl sulfateInactive
Code: 368GB5141J
Classification: IACT
carnauba waxInactive
Code: R12CBM0EIZ
Classification: IACT
cellulose, microcrystallineInactive
Code: OP1R32D61U
Classification: IACT
croscarmellose sodiumInactive
Code: M28OL1HH48
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT