atazanavir sulfate

Generic: atazanavir sulfate

Labeler: teva pharmaceuticals usa, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name atazanavir sulfate
Generic Name atazanavir sulfate
Labeler teva pharmaceuticals usa, inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

atazanavir sulfate 200 mg/1

Manufacturer
Teva Pharmaceuticals USA, Inc.

Identifiers & Regulatory

Product NDC 0093-5527
Product ID 0093-5527_61209ea1-63c7-43fc-ac32-d840a8a0906a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA091673
Listing Expiration 2026-12-31
Marketing Start 2017-12-27

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 00935527
Hyphenated Format 0093-5527

Supplemental Identifiers

RxCUI
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 sulfate (source: ndc)
Application Number ANDA091673 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
source: ndc
Packaging
  • 60 CAPSULE in 1 BOTTLE (0093-5527-06)
source: ndc

Packages (1)

Ingredients (1)

atazanavir sulfate (200 mg/1)

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "61209ea1-63c7-43fc-ac32-d840a8a0906a", "openfda": {"unii": ["4MT4VIE29P"], "rxcui": ["402246", "402247", "664741"], "spl_set_id": ["654b7e08-33d8-47e7-b37f-3681e79c7b8b"], "manufacturer_name": ["Teva Pharmaceuticals USA, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 CAPSULE in 1 BOTTLE (0093-5527-06)", "package_ndc": "0093-5527-06", "marketing_start_date": "20171227"}], "brand_name": "Atazanavir Sulfate", "product_id": "0093-5527_61209ea1-63c7-43fc-ac32-d840a8a0906a", "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": "0093-5527", "generic_name": "Atazanavir Sulfate", "labeler_name": "Teva Pharmaceuticals USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Atazanavir Sulfate", "active_ingredients": [{"name": "ATAZANAVIR SULFATE", "strength": "200 mg/1"}], "application_number": "ANDA091673", "marketing_category": "ANDA", "marketing_start_date": "20171227", "listing_expiration_date": "20261231"}