tadalafil

Orange BookUNIISPLATC G04BE08

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

Identification

ManufacturerBryant Ranch Prepack

CountryUS (United States)

ATC codeG04BE08

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 8

ndc11
7133525831
30 TABLET, FILM COATED in 1 BOTTLE (71335-2583-1)
ndc11
7133525832
10 TABLET, FILM COATED in 1 BOTTLE (71335-2583-2)
ndc11
7133525833
90 TABLET, FILM COATED in 1 BOTTLE (71335-2583-3)
ndc11
7133525834
5 TABLET, FILM COATED in 1 BOTTLE (71335-2583-4)
ndc11
7133525835
60 TABLET, FILM COATED in 1 BOTTLE (71335-2583-5)
ndc11
7133525836
20 TABLET, FILM COATED in 1 BOTTLE (71335-2583-6)
ndc11
7133525837
15 TABLET, FILM COATED in 1 BOTTLE (71335-2583-7)
ndc11
7133525838
100 TABLET, FILM COATED in 1 BOTTLE (71335-2583-8)

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": "71335-2583_43a31ce4-0db9-417a-a1d9-80927c92a4cd",
  "productndc": "71335-2583",
  "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": "20"
}

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