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United States · US · US:42658-115_4bdf0e1b-391f-302e-e063-6294a90ac357

Ticagrelor

Orange BookUNIISPLATC B01AC24

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

Identification

ManufacturerHisun Pharmaceuticals USA, Inc.
CountryUS (United States)
ATC codeB01AC24
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    4265811503
    60 TABLET, FILM COATED in 1 BOTTLE (42658-115-03)

Annotations

UNII (FDA Substance ID)
GLH0314RVC
TICAGRELOR
RxCUI 1116632
Orange Book
A208575
AB
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": "42658-115_4bdf0e1b-391f-302e-e063-6294a90ac357",
  "productndc": "42658-115",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "208575",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "90MG",
        "product_no": "001",
        "approval_date": "Jan 23, 2019"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "TICAGRELOR",
  "proprietary_name": "Ticagrelor",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA208575",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Ticagrelor",
  "start_marketing_date": "20250501",
  "active_numerator_strength": "90"
}

Related drugs

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