tadalafil

Orange BookUNIISPLATC G04BE08

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

Identification

ManufacturerProficient Rx LP

CountryUS (United States)

ATC codeG04BE08

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 5

ndc11
7120575410
10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71205-754-10)
ndc11
7120575420
20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71205-754-20)
ndc11
7120575430
30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71205-754-30)
ndc11
7120575460
60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71205-754-60)
ndc11
7120575490
90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71205-754-90)

Annotations

UNII (FDA Substance ID)

742SXX0ICT

TADALAFIL

RxCUI 358263

Orange Book

A209250

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": "71205-754_ac93704f-8e33-43ba-8b56-3d61092ff1d9",
  "productndc": "71205-754",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "209250",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB1",
        "strength": "2.5MG",
        "product_no": "001",
        "approval_date": "Mar 26, 2019"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB1",
        "strength": "5MG",
        "product_no": "002",
        "approval_date": "Mar 26, 2019"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB1",
        "strength": "10MG",
        "product_no": "003",
        "approval_date": "Mar 26, 2019"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB1",
        "strength": "20MG",
        "product_no": "004",
        "approval_date": "Mar 26, 2019"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "TADALAFIL",
  "proprietary_name": "tadalafil",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA209250",
  "marketing_category": "ANDA",
  "nonproprietary_name": "tadalafil",
  "start_marketing_date": "20190326",
  "active_numerator_strength": "5"
}

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