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United States · US · US:0002-4462_0850d8e6-3c38-484d-990c-fd2780b46454

Cialis

Orange BookUNIISPLATC G04BE08

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

Identification

ManufacturerEli Lilly and Company
CountryUS (United States)
ATC codeG04BE08
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    0002446230
    30 TABLET, FILM COATED in 1 BOTTLE (0002-4462-30)

Annotations

UNII (FDA Substance ID)
742SXX0ICT
TADALAFIL
RxCUI 358263
Orange Book
N021368
AB1AB1AB1
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": {
    "bcd8f8ab-81a2-4891-83db-24a0b0e25895": {
      "match": "brand_token",
      "title": "CIALIS (TADALAFIL) TABLET, FILM COATED [ELI LILLY AND COMPANY]",
      "spl_version": "51",
      "published_date": "2026-04-15"
    }
  },
  "productid": "0002-4462_0850d8e6-3c38-484d-990c-fd2780b46454",
  "productndc": "0002-4462",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "021368",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AB1",
        "strength": "5MG",
        "product_no": "001",
        "approval_date": "Nov 21, 2003"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB1",
        "strength": "10MG",
        "product_no": "002",
        "approval_date": "Nov 21, 2003"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB1",
        "strength": "20MG",
        "product_no": "003",
        "approval_date": "Nov 21, 2003"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
        "product_no": "004",
        "approval_date": "Jan 7, 2008"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "TADALAFIL",
  "proprietary_name": "Cialis",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA021368",
  "marketing_category": "NDA",
  "nonproprietary_name": "Tadalafil",
  "start_marketing_date": "20031126",
  "active_numerator_strength": "5"
}

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