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United States · US · US:33342-432_32769721-c1dd-4bd3-90aa-a6cab59d3cd6

Ticagrelor

Orange BookUNIISPLATC B01AC24

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

Identification

ManufacturerMacleods Pharmaceuticals Limited
CountryUS (United States)
ATC codeB01AC24
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    3334243209
    60 TABLET, FILM COATED in 1 BOTTLE (33342-432-09)
  • ndc11
    3334243212
    10 BLISTER PACK in 1 CARTON (33342-432-12) / 10 TABLET, FILM COATED in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)
GLH0314RVC
TICAGRELOR
RxCUI 1116632
Orange Book
A212258
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": "33342-432_32769721-c1dd-4bd3-90aa-a6cab59d3cd6",
  "productndc": "33342-432",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "212258",
    "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": "ANDA212258",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Ticagrelor",
  "start_marketing_date": "20251028",
  "active_numerator_strength": "90"
}

Related drugs

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