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United States · US · US:60505-4642_4eed584a-92dd-f219-e063-6394a90a0dd0

PRASUGREL

Orange BookUNIISPLATC B01AC22

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

Identification

ManufacturerApotex Corp.
CountryUS (United States)
ATC codeB01AC22
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6050546423
    30 TABLET, FILM COATED in 1 BOTTLE (60505-4642-3)

Annotations

UNII (FDA Substance ID)
G89JQ59I13
PRASUGREL HYDROCHLORIDE
RxCUI 847020
Orange Book
A205897
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": "60505-4642_4eed584a-92dd-f219-e063-6394a90a0dd0",
  "productndc": "60505-4642",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "205897",
    "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": "ANDA205897",
  "marketing_category": "ANDA",
  "nonproprietary_name": "PRASUGREL",
  "start_marketing_date": "20171016",
  "active_numerator_strength": "5"
}

Related drugs

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