darunavir

Generic: darunavir 800 mg

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

Drug Facts

Product Profile

Brand Name darunavir
Generic Name darunavir 800 mg
Labeler exelan pharmaceuticals inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

darunavir hydrate 800 mg/1

Manufacturer
EXELAN PHARMACEUTICALS INC.

Identifiers & Regulatory

Product NDC 76282-738
Product ID 76282-738_d4f6fed4-1a95-4d9a-8395-13818dedccd3
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206288
Listing Expiration 2026-12-31
Marketing Start 2024-01-19

Pharmacologic Class

Classes
cytochrome p450 2d6 inhibitors [moa] cytochrome p450 3a inhibitors [moa] hiv protease inhibitors [moa] protease inhibitor [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 76282738
Hyphenated Format 76282-738

Supplemental Identifiers

RxCUI
670026 1359269
UPC
0376282737607 0376282738307
UNII
KPC4NRB25L

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 800 mg (source: ndc)
Application Number ANDA206288 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 800 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (76282-738-30)
source: ndc

Packages (1)

76282-738-30 30 TABLET in 1 BOTTLE (76282-738-30)

Ingredients (1)

darunavir hydrate (800 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": "d4f6fed4-1a95-4d9a-8395-13818dedccd3", "openfda": {"upc": ["0376282737607", "0376282738307"], "unii": ["KPC4NRB25L"], "rxcui": ["670026", "1359269"], "spl_set_id": ["ed977166-7ac0-4a8c-a10c-4b19a69403c0"], "manufacturer_name": ["EXELAN PHARMACEUTICALS INC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (76282-738-30)", "package_ndc": "76282-738-30", "marketing_start_date": "20240119"}], "brand_name": "darunavir", "product_id": "76282-738_d4f6fed4-1a95-4d9a-8395-13818dedccd3", "dosage_form": "TABLET", "pharm_class": ["Cytochrome P450 2D6 Inhibitors [MoA]", "Cytochrome P450 3A Inhibitors [MoA]", "HIV Protease Inhibitors [MoA]", "Protease Inhibitor [EPC]"], "product_ndc": "76282-738", "generic_name": "darunavir 800 mg", "labeler_name": "EXELAN PHARMACEUTICALS INC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "darunavir", "active_ingredients": [{"name": "DARUNAVIR HYDRATE", "strength": "800 mg/1"}], "application_number": "ANDA206288", "marketing_category": "ANDA", "marketing_start_date": "20240119", "listing_expiration_date": "20261231"}