NDC 70518-0946

Atazanavir Sulfate

Atazanavir Sulfate

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

Product ID70518-0946_62727d79-c39c-3e84-e053-2a91aa0a45f1
NDC70518-0946
Product TypeHuman Prescription Drug
Proprietary NameAtazanavir Sulfate
Generic NameAtazanavir Sulfate
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2018-01-10
Marketing CategoryANDA / ANDA
Application NumberANDA091673
Labeler NameREMEDYREPACK INC.
Substance NameATAZANAVIR SULFATE
Active Ingredient Strength300 mg/1
Pharm ClassesHIV Protease Inhibitors [MoA],Protease Inhibitor [EPC],UGT1A1 Inhibitors [MoA],UDP Glucuronosyltransferases Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 70518-0946-0

30 CAPSULE in 1 BLISTER PACK (70518-0946-0)
Marketing Start Date2018-01-10
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70518-0946-0 [70518094600]

Atazanavir Sulfate CAPSULE
Marketing CategoryANDA
Application NumberANDA091673
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-01-10
Marketing End Date2020-05-07

Drug Details

Active Ingredients

IngredientStrength
ATAZANAVIR SULFATE300 mg/1

OpenFDA Data

SPL SET ID:55e0d267-e44e-4016-9bde-ceb889917444
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 664741

    • Pharmacological Class

    • HIV Protease Inhibitors [MoA]
    • Protease Inhibitor [EPC]
    • UGT1A1 Inhibitors [MoA]
    • UDP Glucuronosyltransferases Inhibitors [MoA]
    • Cytochrome P450 3A4 Inhibitors [MoA]
    • Cytochrome P450 3A Inhibitors [MoA]
    • Cytochrome P450 2C8 Inhibitors [MoA]

    NDC Crossover Matching brand name "Atazanavir Sulfate" or generic name "Atazanavir Sulfate"

    NDCBrand NameGeneric Name
    0093-5526Atazanavir SulfateAtazanavir Sulfate
    0093-5527Atazanavir SulfateAtazanavir Sulfate
    0093-5528Atazanavir SulfateAtazanavir Sulfate
    0904-6875Atazanavir SulfateAtazanavir
    16714-860Atazanavir SulfateAtazanavir
    16714-861Atazanavir SulfateAtazanavir
    16714-862Atazanavir SulfateAtazanavir
    51407-171Atazanavir SulfateAtazanavir Sulfate
    51407-172Atazanavir SulfateAtazanavir Sulfate
    51407-173Atazanavir SulfateAtazanavir Sulfate
    60687-399Atazanavir SulfateAtazanavir
    65862-710Atazanavir SulfateAtazanavir
    65862-711Atazanavir SulfateAtazanavir
    65862-712Atazanavir SulfateAtazanavir
    65862-713Atazanavir SulfateAtazanavir
    70518-1365Atazanavir SulfateAtazanavir Sulfate
    70518-0946Atazanavir SulfateAtazanavir Sulfate
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