NDC 69097-443

ATAZANAVIR

Atazanavir

ATAZANAVIR is a Oral Capsule, Gelatin Coated in the Human Prescription Drug category. It is labeled and distributed by Cipla Usa Inc.. The primary component is Atazanavir Sulfate.

Product ID69097-443_3490acb4-9ec6-4d37-9150-739aa35bcfe6
NDC69097-443
Product TypeHuman Prescription Drug
Proprietary NameATAZANAVIR
Generic NameAtazanavir
Dosage FormCapsule, Gelatin Coated
Route of AdministrationORAL
Marketing Start Date2018-08-09
Marketing CategoryANDA / ANDA
Application NumberANDA200626
Labeler NameCipla USA Inc.
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 Through2020-12-31

Packaging

NDC 69097-443-02

30 CAPSULE, GELATIN COATED in 1 BOTTLE (69097-443-02)
Marketing Start Date2018-08-09
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 69097-443-02 [69097044302]

ATAZANAVIR CAPSULE, GELATIN COATED
Marketing CategoryANDA
Application NumberANDA200626
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-08-09

NDC 69097-443-03 [69097044303]

ATAZANAVIR CAPSULE, GELATIN COATED
Marketing CategoryANDA
Application NumberANDA200626
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-08-09

Drug Details

Active Ingredients

IngredientStrength
ATAZANAVIR SULFATE100 mg/1

OpenFDA Data

SPL SET ID:d1101167-f96b-44ac-9d80-c318287b3069
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 664741
  • 402246
  • 402247
  • 402245
  • UPC Code
  • 0369097443023
  • 0369097445027
  • 0369097446024
  • 0369097444020
  • 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" or generic name "Atazanavir"

    NDCBrand NameGeneric Name
    31722-653AtazanavirAtazanavir
    31722-654AtazanavirAtazanavir
    31722-655AtazanavirAtazanavir
    42385-920AtazanavirAtazanavir
    42385-921AtazanavirAtazanavir
    42385-922AtazanavirAtazanavir
    59762-0408ATAZANAVIRATAZANAVIR
    59762-0409ATAZANAVIRATAZANAVIR
    59762-0410ATAZANAVIRATAZANAVIR
    69097-446ATAZANAVIRATAZANAVIR
    69097-443ATAZANAVIRATAZANAVIR
    69097-444ATAZANAVIRATAZANAVIR
    69097-445ATAZANAVIRATAZANAVIR
    69238-1135AtazanavirAtazanavir
    69238-1136AtazanavirAtazanavir
    69238-1137AtazanavirAtazanavir
    69238-1138AtazanavirAtazanavir
    70518-2832ATAZANAVIRATAZANAVIR
    0904-6875Atazanavir SulfateAtazanavir
    16714-860Atazanavir SulfateAtazanavir
    16714-861Atazanavir SulfateAtazanavir
    16714-862Atazanavir SulfateAtazanavir
    60687-399Atazanavir SulfateAtazanavir
    65862-710Atazanavir SulfateAtazanavir
    65862-711Atazanavir SulfateAtazanavir
    0003-3622REYATAZATAZANAVIR
    0003-3624REYATAZATAZANAVIR
    0003-3631REYATAZATAZANAVIR
    0003-3638REYATAZATAZANAVIR
    50090-1007REYATAZATAZANAVIR
    50090-1581REYATAZATAZANAVIR

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