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 · 7

ndc11
7120573510
10 TABLET in 1 BOTTLE (71205-735-10)
ndc11
7120573514
14 TABLET in 1 BOTTLE (71205-735-14)
ndc11
7120573515
15 TABLET in 1 BOTTLE (71205-735-15)
ndc11
7120573520
20 TABLET in 1 BOTTLE (71205-735-20)
ndc11
7120573530
30 TABLET in 1 BOTTLE (71205-735-30)
ndc11
7120573560
60 TABLET in 1 BOTTLE (71205-735-60)
ndc11
7120573590
90 TABLET in 1 BOTTLE (71205-735-90)

Annotations

UNII (FDA Substance ID)

742SXX0ICT

TADALAFIL

RxCUI 358263

Orange Book

A209654

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": "71205-735_a72a1311-aa68-4567-ac58-97081f675d73",
  "productndc": "71205-735",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "209654",
    "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": "ANDA209654",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Tadalafil",
  "start_marketing_date": "20190326",
  "active_numerator_strength": "10"
}

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