atazanavir sulfate

Generic: atazanavir

Labeler: aurobindo pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name atazanavir sulfate
Generic Name atazanavir
Labeler aurobindo pharma limited
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

atazanavir sulfate 100 mg/1

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 65862-710
Product ID 65862-710_8f8c56e0-40ee-4643-88f7-d3571ff5a409
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204806
Listing Expiration 2026-12-31
Marketing Start 2018-06-25

Pharmacologic Class

Classes
cytochrome p450 2c8 inhibitors [moa] cytochrome p450 3a inhibitors [moa] cytochrome p450 3a4 inhibitors [moa] hiv protease inhibitors [moa] protease inhibitor [epc] udp glucuronosyltransferases inhibitors [moa] ugt1a1 inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 65862710
Hyphenated Format 65862-710

Supplemental Identifiers

RxCUI
402245 402246 402247 664741
UNII
4MT4VIE29P

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name atazanavir sulfate (source: ndc)
Generic Name atazanavir (source: ndc)
Application Number ANDA204806 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 3 BLISTER PACK in 1 CARTON (65862-710-03) / 10 CAPSULE in 1 BLISTER PACK (65862-710-10)
  • 500 CAPSULE in 1 BOTTLE (65862-710-05)
  • 60 CAPSULE in 1 BOTTLE (65862-710-60)
source: ndc

Packages (3)

65862-710-03 3 BLISTER PACK in 1 CARTON (65862-710-03) / 10 CAPSULE in 1 BLISTER PACK (65862-710-10) 65862-710-05 500 CAPSULE in 1 BOTTLE (65862-710-05) 65862-710-60 60 CAPSULE in 1 BOTTLE (65862-710-60)

Ingredients (1)

atazanavir sulfate (100 mg/1)

Linked Drug Pages (1)

Atazanavir Sulfate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "8f8c56e0-40ee-4643-88f7-d3571ff5a409", "openfda": {"unii": ["4MT4VIE29P"], "rxcui": ["402245", "402246", "402247", "664741"], "spl_set_id": ["7fbea274-d6b5-4faa-bbf0-05fefab42114"], "manufacturer_name": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "3 BLISTER PACK in 1 CARTON (65862-710-03)  / 10 CAPSULE in 1 BLISTER PACK (65862-710-10)", "package_ndc": "65862-710-03", "marketing_start_date": "20180625"}, {"sample": false, "description": "500 CAPSULE in 1 BOTTLE (65862-710-05)", "package_ndc": "65862-710-05", "marketing_start_date": "20180625"}, {"sample": false, "description": "60 CAPSULE in 1 BOTTLE (65862-710-60)", "package_ndc": "65862-710-60", "marketing_start_date": "20180625"}], "brand_name": "Atazanavir Sulfate", "product_id": "65862-710_8f8c56e0-40ee-4643-88f7-d3571ff5a409", "dosage_form": "CAPSULE", "pharm_class": ["Cytochrome P450 2C8 Inhibitors [MoA]", "Cytochrome P450 3A Inhibitors [MoA]", "Cytochrome P450 3A4 Inhibitors [MoA]", "HIV Protease Inhibitors [MoA]", "Protease Inhibitor [EPC]", "UDP Glucuronosyltransferases Inhibitors [MoA]", "UGT1A1 Inhibitors [MoA]"], "product_ndc": "65862-710", "generic_name": "Atazanavir", "labeler_name": "Aurobindo Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Atazanavir Sulfate", "active_ingredients": [{"name": "ATAZANAVIR SULFATE", "strength": "100 mg/1"}], "application_number": "ANDA204806", "marketing_category": "ANDA", "marketing_start_date": "20180625", "listing_expiration_date": "20261231"}