DARUNAVIR

Orange BookUNIISPLATC J05AE

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

Identification

ManufacturerLupin Pharmaceuticals, Inc.

CountryUS (United States)

ATC codeJ05AE

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6818034507
60 TABLET, FILM COATED in 1 BOTTLE (68180-345-07)

Annotations

UNII (FDA Substance ID)

33O78XF0BW

DARUNAVIR ETHANOLATE

RxCUI 644682

Orange Book

A202073

ABAB

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "33O78XF0BW",
    "rxcui": "644682",
    "inchikey": "QWSHKNICRJHQCY-VBTXLZOXSA-N",
    "display_name": "DARUNAVIR ETHANOLATE",
    "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": "68180-345_f2b03ba0-704c-447a-a7ab-b4eb00243295",
  "productndc": "68180-345",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "202073",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "600MG",
        "product_no": "001",
        "approval_date": "Sep 29, 2022"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "800MG",
        "product_no": "002",
        "approval_date": "Sep 29, 2022"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "DARUNAVIR ETHANOLATE",
  "proprietary_name": "DARUNAVIR",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA202073",
  "marketing_category": "ANDA",
  "nonproprietary_name": "DARUNAVIR",
  "start_marketing_date": "20230601",
  "active_numerator_strength": "600"
}

Related drugs

Other records sharing ATC code J05AE.

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