NDC 70518-0482

SUSTIVA

Efavirenz

SUSTIVA is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Remedyrepack Inc.. The primary component is Efavirenz.

Product ID70518-0482_5e8765e6-c9ac-d552-e053-2991aa0ae9fa
NDC70518-0482
Product TypeHuman Prescription Drug
Proprietary NameSUSTIVA
Generic NameEfavirenz
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2017-05-22
Marketing CategoryNDA / NDA
Application NumberNDA021360
Labeler NameREMEDYREPACK INC.
Substance NameEFAVIRENZ
Active Ingredient Strength600 mg/1
Pharm ClassesHuman Immunodef
NDC Exclude FlagE
Listing Certified Through2018-12-31

Packaging

NDC 70518-0482-0

30 TABLET, FILM COATED in 1 BLISTER PACK (70518-0482-0)
Marketing Start Date2017-05-05
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70518-0482-0 [70518048200]

SUSTIVA TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA021360
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-05-05
Marketing End Date2020-04-06

Drug Details

Active Ingredients

IngredientStrength
EFAVIRENZ600 mg/1

OpenFDA Data

SPL SET ID:c58db6e8-0451-4908-8a1b-709f7306eb77
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 352143
  • 349477

    • Pharmacological Class

    • Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]
    • Non-Nucleoside Analog [EXT]
    • Non-Nucleoside Reverse Transcriptase Inhibitors [MoA]
    • Cytochrome P450 3A Inducers [MoA]
    • Cytochrome P450 2B6 Inducers [MoA]
    • Cytochrome P450 2C9 Inhibitors [MoA]
    • Cytochrome P450 2C19 Inhibitors [MoA]
    • Cytochrome P450 3A4 Inhibitors [MoA]

    NDC Crossover Matching brand name "SUSTIVA" or generic name "Efavirenz"

    NDCBrand NameGeneric Name
    0056-0470SUSTIVAEfavirenz
    0056-0474SUSTIVAefavirenz
    0056-0510SUSTIVAefavirenz
    70518-0482SUSTIVASUSTIVA
    0378-2233Efavirenzefavirenz
    31722-504EfavirenzEfavirenz
    42543-889EfavirenzEfavirenz
    51407-382EfavirenzEfavirenz
    64380-889EfavirenzEfavirenz
    64980-406EfavirenzEfavirenz
    64980-407EfavirenzEfavirenz
    65862-049EfavirenzEfavirenz
    65862-104EfavirenzEfavirenz

    Trademark Results [SUSTIVA]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    SUSTIVA
    SUSTIVA
    77584955 4179689 Dead/Cancelled
    Bristol-Myers Squibb Pharma Company
    2008-10-03
    SUSTIVA
    SUSTIVA
    75548410 not registered Dead/Abandoned
    DuPont Pharmaceuticals Company
    1998-09-04
    SUSTIVA
    SUSTIVA
    75240870 2496476 Live/Registered
    BRISTOL-MYERS SQUIBB PHARMA COMPANY
    1997-02-12
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