NDC 69315-286

ETRAVIRINE

Etravirine

ETRAVIRINE is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Leading Pharma, Llc. The primary component is Etravirine.

Product ID69315-286_7bcf83e9-1701-49e5-9ddf-fc92906b611b
NDC69315-286
Product TypeHuman Prescription Drug
Proprietary NameETRAVIRINE
Generic NameEtravirine
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2022-06-05
Marketing CategoryANDA /
Application NumberANDA215402
Labeler NameLeading Pharma, LLC
Substance NameETRAVIRINE
Active Ingredient Strength200 mg/1
Pharm ClassesCytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A Inducers [MoA], Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Non-Nucleoside Analog [EXT], Non-Nucleoside Reverse Transcriptase Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 69315-286-06

60 TABLET in 1 BOTTLE (69315-286-06)
Marketing Start Date2022-06-05
NDC Exclude FlagN
Sample Package?N

Drug Details

NDC Crossover Matching brand name "ETRAVIRINE" or generic name "Etravirine"

NDCBrand NameGeneric Name
42291-473etravirineetravirine
42291-474etravirineetravirine
60219-1720etravirineetravirine
60219-1721etravirineetravirine
60219-1722etravirineetravirine
69238-1720etravirineetravirine
69238-1721etravirineetravirine
69238-1722etravirineetravirine
69315-285ETRAVIRINEETRAVIRINE
69315-286ETRAVIRINEETRAVIRINE
80005-112ETRAVIRINEETRAVIRINE
80005-113ETRAVIRINEETRAVIRINE
53808-0787IntelenceEtravirine
59676-570Intelenceetravirine
59676-571Intelenceetravirine
59676-572Intelenceetravirine

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