Darunavir

Orange BookUNIISPLATC J05AE

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

Identification

ManufacturerNuCare Pharmaceuticals, Inc.

CountryUS (United States)

ATC codeJ05AE

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6807139103
3 TABLET, FILM COATED in 1 BOTTLE (68071-3910-3)

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": "68071-3910_42de77fa-91bb-20bb-e063-6394a90ad54d",
  "productndc": "68071-3910",
  "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

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