Tadalafil

Orange BookUNIISPLATC G04BE08

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

Identification

ManufacturerZydus Pharmaceuticals USA Inc.

CountryUS (United States)

ATC codeG04BE08

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 7

ndc11
6838289701
100 TABLET, FILM COATED in 1 BOTTLE (68382-897-01)
ndc11
6838289705
500 TABLET, FILM COATED in 1 BOTTLE (68382-897-05)
ndc11
6838289706
30 TABLET, FILM COATED in 1 BOTTLE (68382-897-06)
ndc11
6838289710
1000 TABLET, FILM COATED in 1 BOTTLE (68382-897-10)
ndc11
6838289716
90 TABLET, FILM COATED in 1 BOTTLE (68382-897-16)
ndc11
6838289750
10 TABLET, FILM COATED in 1 BOTTLE (68382-897-50)
ndc11
6838289799
2 BLISTER PACK in 1 CARTON (68382-897-99) / 15 TABLET, FILM COATED in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)

742SXX0ICT

TADALAFIL

RxCUI 358263

Orange Book

A206693

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": "68382-897_5a958db7-5c0e-4cf0-9227-230886cf9bf8",
  "productndc": "68382-897",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "206693",
    "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": "ANDA206693",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Tadalafil",
  "start_marketing_date": "20190327",
  "active_numerator_strength": "5"
}

Related drugs

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