Tadalafil

Orange BookUNIISPLATC G04BE08

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

Identification

ManufacturerNIVAGEN PHARMACEUTICALS, INC.

CountryUS (United States)

ATC codeG04BE08

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 3

ndc11
7583424901
1000 TABLET, FILM COATED in 1 BOTTLE (75834-249-01)
ndc11
7583424910
30 TABLET, FILM COATED in 1 BLISTER PACK (75834-249-10)
ndc11
7583424930
30 TABLET, FILM COATED in 1 BOTTLE (75834-249-30)

Annotations

UNII (FDA Substance ID)

742SXX0ICT

TADALAFIL

RxCUI 358263

Orange Book

A211298

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": "75834-249_45810509-9e49-3ee2-e063-6394a90aa944",
  "productndc": "75834-249",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "211298",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB1",
        "strength": "2.5MG",
        "product_no": "001",
        "approval_date": "Oct 23, 2020"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB1",
        "strength": "5MG",
        "product_no": "002",
        "approval_date": "Oct 23, 2020"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB1",
        "strength": "10MG",
        "product_no": "003",
        "approval_date": "Oct 23, 2020"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB1",
        "strength": "20MG",
        "product_no": "004",
        "approval_date": "Oct 23, 2020"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "TADALAFIL",
  "proprietary_name": "Tadalafil",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA211298",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Tadalafil",
  "start_marketing_date": "20201102",
  "active_numerator_strength": "10"
}

Related drugs

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