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United States · US · US:50090-7314_2176f66f-e44c-4ab4-9d78-85e95a353b84

tadalafil

Orange BookUNIISPLATC G04BE08

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

Identification

ManufacturerA-S Medication Solutions
CountryUS (United States)
ATC codeG04BE08
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    5009073140
    90 TABLET, FILM COATED in 1 BOTTLE (50090-7314-0)
  • ndc11
    5009073141
    30 TABLET, FILM COATED in 1 BOTTLE (50090-7314-1)

Annotations

UNII (FDA Substance ID)
742SXX0ICT
TADALAFIL
RxCUI 358263
Orange Book
A215556
AB1AB1AB1AB1
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": {
    "b3a58c17-f260-4125-abd1-27da00bb0719": {
      "match": "brand_token",
      "title": "TADALAFIL TABLET [BRYANT RANCH PREPACK]",
      "spl_version": "102",
      "published_date": "2026-06-01"
    }
  },
  "productid": "50090-7314_2176f66f-e44c-4ab4-9d78-85e95a353b84",
  "productndc": "50090-7314",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "215556",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB1",
        "strength": "2.5MG",
        "product_no": "001",
        "approval_date": "Nov 4, 2021"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB1",
        "strength": "5MG",
        "product_no": "002",
        "approval_date": "Nov 4, 2021"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB1",
        "strength": "10MG",
        "product_no": "003",
        "approval_date": "Nov 4, 2021"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB1",
        "strength": "20MG",
        "product_no": "004",
        "approval_date": "Nov 4, 2021"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "TADALAFIL",
  "proprietary_name": "tadalafil",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA215556",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Tadalafil",
  "start_marketing_date": "20230401",
  "active_numerator_strength": "5"
}

Related drugs

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