darunavir

Generic: darunavir

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

Drug Facts

Product Profile

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

darunavir propylene glycolate 800 mg/1

Manufacturer
NuCare Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 68071-3910
Product ID 68071-3910_42de77fa-91bb-20bb-e063-6394a90ad54d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210677
Listing Expiration 2026-12-31
Marketing Start 2023-11-28

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 680713910
Hyphenated Format 68071-3910

Supplemental Identifiers

RxCUI
1359269
UPC
0368071391039
UNII
6M6D7F3VC7

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 ANDA210677 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 800 mg/1
source: ndc
Packaging
  • 3 TABLET, FILM COATED in 1 BOTTLE (68071-3910-3)
source: ndc

Packages (1)

68071-3910-3 3 TABLET, FILM COATED in 1 BOTTLE (68071-3910-3)

Ingredients (1)

darunavir propylene glycolate (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": "42de77fa-91bb-20bb-e063-6394a90ad54d", "openfda": {"upc": ["0368071391039"], "unii": ["6M6D7F3VC7"], "rxcui": ["1359269"], "spl_set_id": ["42cc1b58-2660-f0be-e063-6394a90abe4c"], "manufacturer_name": ["NuCare Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "3 TABLET, FILM COATED in 1 BOTTLE (68071-3910-3)", "package_ndc": "68071-3910-3", "marketing_start_date": "20251104"}], "brand_name": "Darunavir", "product_id": "68071-3910_42de77fa-91bb-20bb-e063-6394a90ad54d", "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": "68071-3910", "generic_name": "Darunavir", "labeler_name": "NuCare Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Darunavir", "active_ingredients": [{"name": "DARUNAVIR PROPYLENE GLYCOLATE", "strength": "800 mg/1"}], "application_number": "ANDA210677", "marketing_category": "ANDA", "marketing_start_date": "20231128", "listing_expiration_date": "20261231"}