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United States · US · US:55488-0543_79364f10-afa0-4a5f-96d2-f82bcc9cf928

Ticagrelor

Orange BookUNIISPLATC B01AC24

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

Identification

ManufacturerChangzhou Pharmaceutical Factory
CountryUS (United States)
ATC codeB01AC24
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    5548805431
    60 TABLET in 1 BOTTLE (55488-0543-1)
  • ndc11
    5548805432
    500 TABLET in 1 BOTTLE (55488-0543-2)

Annotations

UNII (FDA Substance ID)
GLH0314RVC
TICAGRELOR
RxCUI 1116632
Orange Book
A216187
ABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "GLH0314RVC",
    "rxcui": "1116632",
    "inchikey": "OEKWJQXRCDYSHL-FNOIDJSQSA-N",
    "display_name": "TICAGRELOR",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "7efe86fa-5d19-413a-8b15-e51279b62f3f": {
      "match": "brand_token",
      "title": "TICAGRELOR TABLET, FILM COATED [LIFESTAR PHARMA LLC]",
      "spl_version": "10",
      "published_date": "2026-05-28"
    }
  },
  "productid": "55488-0543_79364f10-afa0-4a5f-96d2-f82bcc9cf928",
  "productndc": "55488-0543",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "216187",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "60MG",
        "product_no": "001",
        "approval_date": "Oct 28, 2025"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "90MG",
        "product_no": "002",
        "approval_date": "Oct 28, 2025"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "TICAGRELOR",
  "proprietary_name": "Ticagrelor",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA216187",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Ticagrelor",
  "start_marketing_date": "20251028",
  "active_numerator_strength": "90"
}

Related drugs

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