Tadalafil

Orange BookUNIISPLATC G04BE08

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

Identification

ManufacturerAlembic Pharmaceuticals Inc.

CountryUS (United States)

ATC codeG04BE08

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 4

ndc11
6233217815
30 TABLET, COATED in 1 CARTON (62332-178-15)
ndc11
6233217830
30 TABLET, COATED in 1 BOTTLE (62332-178-30)
ndc11
6233217871
500 TABLET, COATED in 1 BOTTLE (62332-178-71)
ndc11
6233217891
1000 TABLET, COATED in 1 BOTTLE (62332-178-91)

Annotations

UNII (FDA Substance ID)

742SXX0ICT

TADALAFIL

RxCUI 358263

Orange Book

A204809

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": "62332-178_76b22a5c-175e-433e-bd1e-5fefb0a78d5f",
  "productndc": "62332-178",
  "dosage_form": "TABLET, COATED",
  "orange_book": {
    "appl_no": "204809",
    "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": "ANDA204809",
  "marketing_category": "ANDA",
  "nonproprietary_name": "tadalafil",
  "start_marketing_date": "20190326",
  "active_numerator_strength": "5"
}

Related drugs

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