NDC 65862-105

Efavirenz

Efavirenz

Efavirenz is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Aurobindo Pharma Limited. The primary component is Efavirenz.

Product ID65862-105_33ce13f3-f7d1-4b6e-93e7-b8aa106d5f9b
NDC65862-105
Product TypeHuman Prescription Drug
Proprietary NameEfavirenz
Generic NameEfavirenz
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2017-12-15
Marketing CategoryANDA / ANDA
Application NumberANDA078064
Labeler NameAurobindo Pharma Limited
Substance NameEFAVIRENZ
Active Ingredient Strength100 mg/1
Pharm ClassesCytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A Inducers [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Non-Nucleoside Analog [EXT], Non-Nucleoside Reverse Transcriptase Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 65862-105-10

3 BLISTER PACK in 1 CARTON (65862-105-10) > 10 CAPSULE in 1 BLISTER PACK
Marketing Start Date2017-12-15
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 65862-105-30 [65862010530]

Efavirenz CAPSULE
Marketing CategoryANDA
Application NumberANDA078064
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-12-15

NDC 65862-105-10 [65862010510]

Efavirenz CAPSULE
Marketing CategoryANDA
Application NumberANDA078064
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-12-15

Drug Details

Active Ingredients

IngredientStrength
EFAVIRENZ100 mg/1

OpenFDA Data

SPL SET ID:4c57ad7f-321a-46c8-851a-c895466eb8e1
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 205292
  • 205290
  • 205291
  • UPC Code
  • 0365862106308
  • 0365862105301
  • 0365862104106
  • 0365862105103
  • 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

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.