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United States · US · US:29300-301_b60d626b-a3ab-45a0-9abc-cce73f2039da
Prasugrel
Orange BookUNIISPLATC B01AC22
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerUnichem Pharmaceuticals (USA), Inc.
CountryUS (United States)
ATC codeB01AC22
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11293003011330 TABLET, FILM COATED in 1 BOTTLE (29300-301-13)
Annotations
UNII (FDA Substance ID)
G89JQ59I13
PRASUGREL HYDROCHLORIDE
RxCUI 847020
Orange Book
A213315
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": "29300-301_b60d626b-a3ab-45a0-9abc-cce73f2039da",
"productndc": "29300-301",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "213315",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 5MG BASE",
"product_no": "001",
"approval_date": "Aug 28, 2023"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 10MG BASE",
"product_no": "002",
"approval_date": "Aug 28, 2023"
}
],
"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": "ANDA213315",
"marketing_category": "ANDA",
"nonproprietary_name": "Prasugrel",
"start_marketing_date": "20231016",
"active_numerator_strength": "5"
}Related drugs
Other records sharing ATC code B01AC22.
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