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United States · US · US:71610-914_4887c1b7-be57-6eb9-e063-6294a90ab88d

TICAGRELOR

Orange BookUNIISPLATC B01AC24

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

Identification

ManufacturerAphena Pharma Solutions - Tennessee, LLC
CountryUS (United States)
ATC codeB01AC24
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    7161091441
    5400 TABLET, FILM COATED in 1 BOTTLE (71610-914-41)
  • ndc11
    7161091442
    1800 TABLET, FILM COATED in 1 BOTTLE (71610-914-42)

Annotations

UNII (FDA Substance ID)
GLH0314RVC
TICAGRELOR
RxCUI 1116632
Orange Book
A208537
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": "71610-914_4887c1b7-be57-6eb9-e063-6294a90ab88d",
  "productndc": "71610-914",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "208537",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "90MG",
        "product_no": "001",
        "approval_date": "May 5, 2025"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "60MG",
        "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": "ANDA208537",
  "marketing_category": "ANDA",
  "nonproprietary_name": "TICAGRELOR",
  "start_marketing_date": "20250507",
  "active_numerator_strength": "90"
}

Related drugs

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