NDC 70518-1100

Efavirenz

Efavirenz

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

Product ID70518-1100_6984f0ef-4991-b60b-e053-2991aa0a583a
NDC70518-1100
Product TypeHuman Prescription Drug
Proprietary NameEfavirenz
Generic NameEfavirenz
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2018-04-06
Marketing CategoryANDA / ANDA
Application NumberANDA204869
Labeler NameREMEDYREPACK 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 70518-1100-0

30 TABLET in 1 BLISTER PACK (70518-1100-0)
Marketing Start Date2018-04-06
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70518-1100-0 [70518110000]

Efavirenz TABLET
Marketing CategoryANDA
Application NumberANDA204869
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-04-06

Drug Details

Active Ingredients

IngredientStrength
EFAVIRENZ600 mg/1

OpenFDA Data

SPL SET ID:84af9f75-80ef-461c-8034-c0587a722930
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 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 "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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