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United States · US · US:66302-467_76c30323-0981-499c-b552-1a43f01c89c8

ADCIRCA

Orange BookUNIISPLATC G04BE08

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerUnited Therapeutics Corporation
CountryUS (United States)
ATC codeG04BE08
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6630246760
    60 TABLET in 1 BOTTLE (66302-467-60)

Annotations

UNII (FDA Substance ID)
742SXX0ICT
TADALAFIL
RxCUI 358263
Orange Book
N022332
AB2
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "742SXX0ICT",
    "rxcui": "358263",
    "inchikey": "WOXKDUGGOYFFRN-IIBYNOLFSA-N",
    "display_name": "TADALAFIL",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "ff61b237-be8e-461b-8114-78c52a8ad0ae": {
      "match": "brand_token",
      "title": "ADCIRCA (TADALAFIL) TABLET [UNITED THERAPEUTICS CORPORATION]",
      "spl_version": "34",
      "published_date": "2025-12-16"
    }
  },
  "productid": "66302-467_76c30323-0981-499c-b552-1a43f01c89c8",
  "productndc": "66302-467",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "022332",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AB2",
        "strength": "20MG",
        "product_no": "001",
        "approval_date": "May 22, 2009"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "TADALAFIL",
  "proprietary_name": "ADCIRCA",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA022332",
  "marketing_category": "NDA",
  "nonproprietary_name": "Tadalafil",
  "start_marketing_date": "20090522",
  "active_numerator_strength": "20"
}

Related drugs

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