darunavir

Generic: darunavir

Labeler: aurobindo pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name darunavir
Generic Name darunavir
Labeler aurobindo pharma limited
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

darunavir propylene glycolate 600 mg/1

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 59651-085
Product ID 59651-085_2b5403e0-28fe-44ef-9b80-f754181ba220
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 59651085
Hyphenated Format 59651-085

Supplemental Identifiers

RxCUI
670026 1359269
UNII
6M6D7F3VC7

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 ANDA210677 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 600 mg/1
source: ndc
Packaging
  • 60 TABLET, FILM COATED in 1 BOTTLE (59651-085-60)
source: ndc

Packages (1)

59651-085-60 60 TABLET, FILM COATED in 1 BOTTLE (59651-085-60)

Ingredients (1)

darunavir propylene glycolate (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": "2b5403e0-28fe-44ef-9b80-f754181ba220", "openfda": {"unii": ["6M6D7F3VC7"], "rxcui": ["670026", "1359269"], "spl_set_id": ["88910ad0-6dc3-4a47-8a6b-5c6ee79f2a93"], "manufacturer_name": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (59651-085-60)", "package_ndc": "59651-085-60", "marketing_start_date": "20231128"}], "brand_name": "Darunavir", "product_id": "59651-085_2b5403e0-28fe-44ef-9b80-f754181ba220", "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": "59651-085", "generic_name": "Darunavir", "labeler_name": "Aurobindo Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Darunavir", "active_ingredients": [{"name": "DARUNAVIR PROPYLENE GLYCOLATE", "strength": "600 mg/1"}], "application_number": "ANDA210677", "marketing_category": "ANDA", "marketing_start_date": "20231128", "listing_expiration_date": "20261231"}