NDC 65862-710

Atazanavir Sulfate

Atazanavir

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

Product ID65862-710_62e8a328-607a-4ab8-9167-c0162025b8f6
NDC65862-710
Product TypeHuman Prescription Drug
Proprietary NameAtazanavir Sulfate
Generic NameAtazanavir
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2018-06-25
Marketing CategoryANDA / ANDA
Application NumberANDA204806
Labeler NameAurobindo Pharma Limited
Substance NameATAZANAVIR SULFATE
Active Ingredient Strength100 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 Through2021-12-31

Packaging

NDC 65862-710-03

3 BLISTER PACK in 1 CARTON (65862-710-03) > 10 CAPSULE in 1 BLISTER PACK (65862-710-10)
Marketing Start Date2018-06-25
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 65862-710-60 [65862071060]

Atazanavir Sulfate CAPSULE
Marketing CategoryANDA
Application NumberANDA204806
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-06-25

NDC 65862-710-03 [65862071003]

Atazanavir Sulfate CAPSULE
Marketing CategoryANDA
Application NumberANDA204806
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-06-25

NDC 65862-710-10 [65862071010]

Atazanavir Sulfate CAPSULE
Marketing CategoryANDA
Application NumberANDA204806
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-06-25

NDC 65862-710-05 [65862071005]

Atazanavir Sulfate CAPSULE
Marketing CategoryANDA
Application NumberANDA204806
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-06-25

Drug Details

Active Ingredients

IngredientStrength
ATAZANAVIR SULFATE100 mg/1

OpenFDA Data

SPL SET ID:7fbea274-d6b5-4faa-bbf0-05fefab42114
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 664741
  • 402246
  • 402247
  • 402245
  • 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"

    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
    70518-1365Atazanavir SulfateAtazanavir Sulfate
    70518-0946Atazanavir SulfateAtazanavir Sulfate
    51407-172Atazanavir SulfateAtazanavir Sulfate
    51407-171Atazanavir SulfateAtazanavir Sulfate
    51407-173Atazanavir SulfateAtazanavir Sulfate
    60687-399Atazanavir SulfateAtazanavir Sulfate
    65862-712Atazanavir SulfateAtazanavir Sulfate
    65862-713Atazanavir SulfateAtazanavir Sulfate
    65862-710Atazanavir SulfateAtazanavir Sulfate
    65862-711Atazanavir SulfateAtazanavir Sulfate
    31722-653AtazanavirAtazanavir
    31722-654AtazanavirAtazanavir
    31722-655AtazanavirAtazanavir
    42385-920AtazanavirAtazanavir
    0003-3622REYATAZATAZANAVIR
    0003-3624REYATAZATAZANAVIR
    0003-3631REYATAZATAZANAVIR
    0003-3638REYATAZATAZANAVIR

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