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United States · US · US:67877-522_0e2da4e0-7930-4f20-a63e-bd8b75cfb47d

Ticagrelor

Orange BookUNIISPLATC B01AC24

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

Identification

ManufacturerAscend Laboratories, LLC
CountryUS (United States)
ATC codeB01AC24
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 5

  • ndc11
    6787752205
    500 TABLET, FILM COATED in 1 BOTTLE (67877-522-05)
  • ndc11
    6787752214
    14 TABLET, FILM COATED in 1 BOTTLE (67877-522-14)
  • ndc11
    6787752218
    180 TABLET, FILM COATED in 1 BOTTLE (67877-522-18)
  • ndc11
    6787752238
    10 BLISTER PACK in 1 CARTON (67877-522-38) / 10 TABLET, FILM COATED in 1 BLISTER PACK
  • ndc11
    6787752260
    60 TABLET, FILM COATED in 1 BOTTLE (67877-522-60)

Annotations

UNII (FDA Substance ID)
GLH0314RVC
TICAGRELOR
RxCUI 1116632
Orange Book
A210219
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": "67877-522_0e2da4e0-7930-4f20-a63e-bd8b75cfb47d",
  "productndc": "67877-522",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "210219",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "60MG",
        "product_no": "001",
        "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": "ANDA210219",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Ticagrelor",
  "start_marketing_date": "20251028",
  "active_numerator_strength": "60"
}

Related drugs

Other records sharing ATC code B01AC24.

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