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United States · US · US:43547-657_d51fdfca-5940-4b3c-bfa2-003b208b9309

TICAGRELOR

Orange BookUNIISPLATC B01AC24

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

Identification

ManufacturerSolco Healthcare U.S., LLC
CountryUS (United States)
ATC codeB01AC24
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    4354765706
    60 TABLET, FILM COATED in 1 BOTTLE (43547-657-06)
  • ndc11
    4354765718
    180 TABLET, FILM COATED in 1 BOTTLE (43547-657-18)
  • ndc11
    4354765750
    500 TABLET, FILM COATED in 1 BOTTLE (43547-657-50)

Annotations

UNII (FDA Substance ID)
GLH0314RVC
TICAGRELOR
RxCUI 1116632
Orange Book
A208599
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": "43547-657_d51fdfca-5940-4b3c-bfa2-003b208b9309",
  "productndc": "43547-657",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "208599",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "90MG",
        "product_no": "001",
        "approval_date": "Aug 16, 2024"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "TICAGRELOR",
  "proprietary_name": "TICAGRELOR",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA208599",
  "marketing_category": "ANDA",
  "nonproprietary_name": "ticagrelor",
  "start_marketing_date": "20250401",
  "active_numerator_strength": "90"
}

Related drugs

Other records sharing ATC code B01AC24.

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