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United States · US · US:60687-883_2ddfdce2-a7ba-b612-e063-6294a90a0ce3

Prasugrel

Orange BookUNIISPLATC B01AC22

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

Identification

ManufacturerAmerican Health Packaging
CountryUS (United States)
ATC codeB01AC22
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6068788321
    30 BLISTER PACK in 1 CARTON (60687-883-21) / 1 TABLET, FILM COATED in 1 BLISTER PACK (60687-883-11)

Annotations

UNII (FDA Substance ID)
G89JQ59I13
PRASUGREL HYDROCHLORIDE
RxCUI 847020
Orange Book
A205888
ABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "G89JQ59I13",
    "rxcui": "847020",
    "inchikey": "JALHGCPDPSNJNY-UHFFFAOYSA-N",
    "display_name": "PRASUGREL HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "f51e64e0-f556-65d0-a876-fb709aaeefea": {
      "match": "brand_token",
      "title": "PRASUGREL TABLET, FILM COATED [APOTEX CORP.]",
      "spl_version": "9",
      "published_date": "2026-04-09"
    }
  },
  "productid": "60687-883_2ddfdce2-a7ba-b612-e063-6294a90a0ce3",
  "productndc": "60687-883",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "205888",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 5MG BASE",
        "product_no": "001",
        "approval_date": "Oct 16, 2017"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 10MG BASE",
        "product_no": "002",
        "approval_date": "Oct 16, 2017"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "PRASUGREL HYDROCHLORIDE",
  "proprietary_name": "Prasugrel",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA205888",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Prasugrel",
  "start_marketing_date": "20250302",
  "active_numerator_strength": "10"
}

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