darunavir

Generic: darunavir

Labeler: american health packaging
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name darunavir
Generic Name darunavir
Labeler american health packaging
Dosage Form TABLET
Routes
ORAL
Active Ingredients

darunavir dihydrate 800 mg/1

Manufacturer
American Health Packaging

Identifiers & Regulatory

Product NDC 60687-819
Product ID 60687-819_1a392399-f30c-b533-e063-6294a90a1e67
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206288
Listing Expiration 2026-12-31
Marketing Start 2024-06-09

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 60687819
Hyphenated Format 60687-819

Supplemental Identifiers

RxCUI
670026 1359269
UNII
KPC4NRB25L

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 ANDA206288 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 800 mg/1
source: ndc
Packaging
  • 30 BLISTER PACK in 1 CARTON (60687-819-21) / 1 TABLET in 1 BLISTER PACK (60687-819-11)
source: ndc

Packages (1)

60687-819-21 30 BLISTER PACK in 1 CARTON (60687-819-21) / 1 TABLET in 1 BLISTER PACK (60687-819-11)

Ingredients (1)

darunavir dihydrate (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": "1a392399-f30c-b533-e063-6294a90a1e67", "openfda": {"unii": ["KPC4NRB25L"], "rxcui": ["670026", "1359269"], "spl_set_id": ["632293b0-d220-444e-8a5b-2ee8c225b66d"], "manufacturer_name": ["American Health Packaging"]}, "finished": true, "packaging": [{"sample": false, "description": "30 BLISTER PACK in 1 CARTON (60687-819-21)  / 1 TABLET in 1 BLISTER PACK (60687-819-11)", "package_ndc": "60687-819-21", "marketing_start_date": "20240609"}], "brand_name": "Darunavir", "product_id": "60687-819_1a392399-f30c-b533-e063-6294a90a1e67", "dosage_form": "TABLET", "pharm_class": ["Cytochrome P450 2D6 Inhibitors [MoA]", "Cytochrome P450 3A Inhibitors [MoA]", "HIV Protease Inhibitors [MoA]", "Protease Inhibitor [EPC]"], "product_ndc": "60687-819", "generic_name": "Darunavir", "labeler_name": "American Health Packaging", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Darunavir", "active_ingredients": [{"name": "DARUNAVIR DIHYDRATE", "strength": "800 mg/1"}], "application_number": "ANDA206288", "marketing_category": "ANDA", "marketing_start_date": "20240609", "listing_expiration_date": "20261231"}