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United States · US · US:43598-629_b3d72d98-872a-adfa-108f-3c2c60fe8703

Ticagrelor

Orange BookUNIISPLATC B01AC24

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

Identification

ManufacturerDr. Reddys Laboratories Inc
CountryUS (United States)
ATC codeB01AC24
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    4359862918
    180 TABLET in 1 BOTTLE (43598-629-18)
  • ndc11
    4359862960
    60 TABLET in 1 BOTTLE (43598-629-60)

Annotations

UNII (FDA Substance ID)
GLH0314RVC
TICAGRELOR
RxCUI 1116632
Orange Book
A208541
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": "43598-629_b3d72d98-872a-adfa-108f-3c2c60fe8703",
  "productndc": "43598-629",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "208541",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "90MG",
        "product_no": "001",
        "approval_date": "Oct 29, 2024"
      },
      {
        "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": "ANDA208541",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Ticagrelor",
  "start_marketing_date": "20251028",
  "active_numerator_strength": "60"
}

Related drugs

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