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United States · US · US:46287-045_cf6ec62b-5d5e-49ed-8d46-8a759d0e2b93

TADLIQ

Orange BookUNIISPLATC G04BE08

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

Identification

ManufacturerCMP Pharma, Inc.
CountryUS (United States)
ATC codeG04BE08
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    4628704515
    150 mL in 1 BOTTLE (46287-045-15)

Annotations

UNII (FDA Substance ID)
742SXX0ICT
TADALAFIL
RxCUI 358263
Orange Book
N214522
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": {
    "7a909b25-3772-403e-a5fe-e4a040293fb7": {
      "match": "brand_token",
      "title": "TADLIQ (TADALAFIL) SUSPENSION [CMP PHARMA, INC.]",
      "spl_version": "6",
      "published_date": "2025-12-24"
    }
  },
  "productid": "46287-045_cf6ec62b-5d5e-49ed-8d46-8a759d0e2b93",
  "productndc": "46287-045",
  "dosage_form": "SUSPENSION",
  "orange_book": {
    "appl_no": "214522",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "20MG/5ML",
        "product_no": "001",
        "approval_date": "Jun 17, 2022"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "TADALAFIL",
  "proprietary_name": "TADLIQ",
  "active_ingred_unit": "mg/5mL",
  "application_number": "NDA214522",
  "marketing_category": "NDA",
  "nonproprietary_name": "Tadalafil",
  "start_marketing_date": "20220830",
  "active_numerator_strength": "20"
}

Related drugs

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