NDC 69097-301

Efavirenz

Efavirenz

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

Product ID69097-301_1ecec4ee-d14a-472d-b287-f416eb0f5405
NDC69097-301
Product TypeHuman Prescription Drug
Proprietary NameEfavirenz
Generic NameEfavirenz
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2018-06-18
Marketing CategoryANDA / ANDA
Application NumberANDA204766
Labeler NameCipla USA Inc.
Substance NameEFAVIRENZ
Active Ingredient Strength600 mg/1
Pharm ClassesHuman 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 Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 69097-301-02

30 TABLET, FILM COATED in 1 BOTTLE (69097-301-02)
Marketing Start Date2018-06-18
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 69097-301-02 [69097030102]

Efavirenz TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA204766
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-06-18

Drug Details

Active Ingredients

IngredientStrength
EFAVIRENZ600 mg/1

OpenFDA Data

SPL SET ID:92603fa5-7a2c-4bfb-9a70-aadb4fba952c
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 349477
  • UPC Code
  • 0369097301026
  • 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]

    Medicade Reported Pricing

    69097030102 EFAVIRENZ 600 MG TABLET

    Pricing Unit: EA | Drug Type:

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

    NDCBrand NameGeneric Name
    0378-2233Efavirenzefavirenz
    31722-504EfavirenzEfavirenz
    42543-889EfavirenzEfavirenz
    51407-382EfavirenzEfavirenz
    64380-889EfavirenzEfavirenz
    64980-406EfavirenzEfavirenz
    64980-407EfavirenzEfavirenz
    65862-049EfavirenzEfavirenz
    65862-104EfavirenzEfavirenz
    69097-301EfavirenzEfavirenz
    70518-1100EfavirenzEfavirenz
    70518-1013EfavirenzEfavirenz
    65862-105EfavirenzEfavirenz
    65862-106EfavirenzEfavirenz
    65862-774EfavirenzEfavirenz
    0056-0470SUSTIVAEfavirenz
    0056-0474SUSTIVAefavirenz
    0056-0510SUSTIVAefavirenz

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