darunavir

Generic: darunavir

Labeler: viona pharmaceuticals inc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name darunavir
Generic Name darunavir
Labeler viona pharmaceuticals inc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

darunavir 600 mg/1

Manufacturer
Viona Pharmaceuticals Inc

Identifiers & Regulatory

Product NDC 72578-147
Product ID 72578-147_de3be678-a82f-4052-b7ce-728d887d548e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA214085
Listing Expiration 2026-12-31
Marketing Start 2024-05-01

Pharmacologic Class

Established (EPC)
protease inhibitor [epc]
Mechanism of Action
hiv protease inhibitors [moa] cytochrome p450 3a inhibitors [moa] cytochrome p450 2d6 inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72578147
Hyphenated Format 72578-147

Supplemental Identifiers

RxCUI
670026 1359269
UNII
YO603Y8113
NUI
N0000000246 N0000175889 N0000190114 N0000182137

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 darunavir (source: ndc)
Generic Name darunavir (source: ndc)
Application Number ANDA214085 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 600 mg/1
source: ndc
Packaging
  • 500 TABLET, FILM COATED in 1 BOTTLE (72578-147-05)
  • 60 TABLET, FILM COATED in 1 BOTTLE (72578-147-14)
  • 180 TABLET, FILM COATED in 1 BOTTLE (72578-147-28)
source: ndc

Packages (3)

72578-147-05 500 TABLET, FILM COATED in 1 BOTTLE (72578-147-05) 72578-147-14 60 TABLET, FILM COATED in 1 BOTTLE (72578-147-14) 72578-147-28 180 TABLET, FILM COATED in 1 BOTTLE (72578-147-28)

Ingredients (1)

darunavir (600 mg/1)

Linked Drug Pages (1)

Darunavir ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "de3be678-a82f-4052-b7ce-728d887d548e", "openfda": {"nui": ["N0000000246", "N0000175889", "N0000190114", "N0000182137"], "unii": ["YO603Y8113"], "rxcui": ["670026", "1359269"], "spl_set_id": ["04a542b3-15ad-4a8a-aab4-ace8e08732f3"], "pharm_class_epc": ["Protease Inhibitor [EPC]"], "pharm_class_moa": ["HIV Protease Inhibitors [MoA]", "Cytochrome P450 3A Inhibitors [MoA]", "Cytochrome P450 2D6 Inhibitors [MoA]"], "manufacturer_name": ["Viona Pharmaceuticals Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (72578-147-05)", "package_ndc": "72578-147-05", "marketing_start_date": "20240501"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (72578-147-14)", "package_ndc": "72578-147-14", "marketing_start_date": "20240501"}, {"sample": false, "description": "180 TABLET, FILM COATED in 1 BOTTLE (72578-147-28)", "package_ndc": "72578-147-28", "marketing_start_date": "20240501"}], "brand_name": "Darunavir", "product_id": "72578-147_de3be678-a82f-4052-b7ce-728d887d548e", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Cytochrome P450 2D6 Inhibitors [MoA]", "Cytochrome P450 3A Inhibitors [MoA]", "HIV Protease Inhibitors [MoA]", "Protease Inhibitor [EPC]"], "product_ndc": "72578-147", "generic_name": "Darunavir", "labeler_name": "Viona Pharmaceuticals Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Darunavir", "active_ingredients": [{"name": "DARUNAVIR", "strength": "600 mg/1"}], "application_number": "ANDA214085", "marketing_category": "ANDA", "marketing_start_date": "20240501", "listing_expiration_date": "20261231"}