atazanavir

Generic: atazanavir

Labeler: laurus labs limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name atazanavir
Generic Name atazanavir
Labeler laurus labs limited
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

atazanavir sulfate 300 mg/1

Manufacturer
Laurus Labs Limited

Identifiers & Regulatory

Product NDC 42385-922
Product ID 42385-922_0e18774c-a32c-4961-9684-f5c6ffce64a1
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212579
Listing Expiration 2026-12-31
Marketing Start 2021-04-30

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 42385922
Hyphenated Format 42385-922

Supplemental Identifiers

RxCUI
402246 402247 664741
UPC
0342385922301
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 (source: ndc)
Generic Name atazanavir (source: ndc)
Application Number ANDA212579 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 300 mg/1
source: ndc
Packaging
  • 30 CAPSULE in 1 BOTTLE (42385-922-30)
  • 5 BLISTER PACK in 1 CARTON (42385-922-37) / 6 CAPSULE in 1 BLISTER PACK (42385-922-06)
source: ndc

Packages (2)

42385-922-30 30 CAPSULE in 1 BOTTLE (42385-922-30) 42385-922-37 5 BLISTER PACK in 1 CARTON (42385-922-37) / 6 CAPSULE in 1 BLISTER PACK (42385-922-06)

Ingredients (1)

atazanavir sulfate (300 mg/1)

Linked Drug Pages (1)

Atazanavir ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "0e18774c-a32c-4961-9684-f5c6ffce64a1", "openfda": {"upc": ["0342385922301"], "unii": ["4MT4VIE29P"], "rxcui": ["402246", "402247", "664741"], "spl_set_id": ["c98e40ec-8a2c-4f19-b1c3-c82f708c2490"], "manufacturer_name": ["Laurus Labs Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE in 1 BOTTLE (42385-922-30)", "package_ndc": "42385-922-30", "marketing_start_date": "20210430"}, {"sample": false, "description": "5 BLISTER PACK in 1 CARTON (42385-922-37)  / 6 CAPSULE in 1 BLISTER PACK (42385-922-06)", "package_ndc": "42385-922-37", "marketing_start_date": "20210430"}], "brand_name": "Atazanavir", "product_id": "42385-922_0e18774c-a32c-4961-9684-f5c6ffce64a1", "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": "42385-922", "generic_name": "Atazanavir", "labeler_name": "Laurus Labs Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Atazanavir", "active_ingredients": [{"name": "ATAZANAVIR SULFATE", "strength": "300 mg/1"}], "application_number": "ANDA212579", "marketing_category": "ANDA", "marketing_start_date": "20210430", "listing_expiration_date": "20261231"}