Back to search
🇺🇸

United States · US · US:13668-581_1f85153f-5d3a-40d8-8570-1d969f4efa3c

TADALAFIL

Orange BookUNIISPLATC G04BE08

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

Identification

ManufacturerTorrent Pharmaceuticals Limited
CountryUS (United States)
ATC codeG04BE08
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    1366858130
    30 TABLET in 1 BOTTLE (13668-581-30)
  • ndc11
    1366858160
    60 TABLET in 1 BOTTLE (13668-581-60)

Annotations

UNII (FDA Substance ID)
742SXX0ICT
TADALAFIL
RxCUI 358263
Orange Book
A212062
AB2
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": "13668-581_1f85153f-5d3a-40d8-8570-1d969f4efa3c",
  "productndc": "13668-581",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "212062",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB2",
        "strength": "20MG",
        "product_no": "001",
        "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": "ANDA212062",
  "marketing_category": "ANDA",
  "nonproprietary_name": "TADALAFIL",
  "start_marketing_date": "20190326",
  "active_numerator_strength": "20"
}

Related drugs

Other records sharing ATC code G04BE08.

Access this data programmatically

Query TADALAFIL and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.