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United States · US · US:46708-241_ef3c94fb-69c7-4649-874d-bb4bedc1152d

Ticagrelor

Orange BookUNIISPLATC B01AC24

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

Identification

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

Packs · 4

  • ndc11
    4670824130
    30 TABLET, FILM COATED in 1 BOTTLE (46708-241-30)
  • ndc11
    4670824131
    100 TABLET, FILM COATED in 1 BOTTLE (46708-241-31)
  • ndc11
    4670824160
    60 TABLET, FILM COATED in 1 BOTTLE (46708-241-60)
  • ndc11
    4670824191
    1000 TABLET, FILM COATED in 1 BOTTLE (46708-241-91)

Annotations

UNII (FDA Substance ID)
GLH0314RVC
TICAGRELOR
RxCUI 1116632
Orange Book
A208576
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": "46708-241_ef3c94fb-69c7-4649-874d-bb4bedc1152d",
  "productndc": "46708-241",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "208576",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "90MG",
        "product_no": "001",
        "approval_date": "May 1, 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": "ANDA208576",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Ticagrelor",
  "start_marketing_date": "20250501",
  "active_numerator_strength": "90"
}

Related drugs

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