Darunavir

Orange BookUNIISPLATC J05AE

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerAurobindo Pharma Limited

CountryUS (United States)

ATC codeJ05AE

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
5965108630
30 TABLET, FILM COATED in 1 BOTTLE (59651-086-30)

Annotations

UNII (FDA Substance ID)

6M6D7F3VC7

DARUNAVIR PROPYLENE GLYCOLATE

Orange Book

A210677

ABAB

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "6M6D7F3VC7",
    "rxcui": null,
    "inchikey": "LMVMDGVDHYKETG-VBTXLZOXSA-N",
    "display_name": "DARUNAVIR PROPYLENE GLYCOLATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "e80e44f8-1987-4b78-a63d-a4e4d5122ddb": {
      "match": "brand_token",
      "title": "DARUNAVIR TABLET, FILM COATED [BRYANT RANCH PREPACK]",
      "spl_version": "100",
      "published_date": "2026-03-12"
    }
  },
  "productid": "59651-086_2b5403e0-28fe-44ef-9b80-f754181ba220",
  "productndc": "59651-086",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "210677",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "600MG",
        "product_no": "001",
        "approval_date": "Nov 28, 2023"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "800MG",
        "product_no": "002",
        "approval_date": "Nov 28, 2023"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "DARUNAVIR PROPYLENE GLYCOLATE",
  "proprietary_name": "Darunavir",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA210677",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Darunavir",
  "start_marketing_date": "20231128",
  "active_numerator_strength": "800"
}

Related drugs

Other records sharing ATC code J05AE.

Access this data programmatically

Query Darunavir and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.

Get a free API key Read the API docs