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United States · US · US:65162-002_ae5f7419-c5fe-4462-8f0e-ffc08e891cd0
Prasugrel
Orange BookUNIISPLATC B01AC22
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAmneal Pharmaceuticals LLC
CountryUS (United States)
ATC codeB01AC22
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11651620020330 TABLET, FILM COATED in 1 BOTTLE (65162-002-03)
Annotations
UNII (FDA Substance ID)
G89JQ59I13
PRASUGREL HYDROCHLORIDE
RxCUI 847020
Orange Book
A205913
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": "65162-002_ae5f7419-c5fe-4462-8f0e-ffc08e891cd0",
"productndc": "65162-002",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "205913",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "EQ 5MG BASE",
"product_no": "001",
"approval_date": "Jun 19, 2018"
},
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "EQ 10MG BASE",
"product_no": "002",
"approval_date": "Jun 19, 2018"
}
],
"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": "ANDA205913",
"marketing_category": "ANDA",
"nonproprietary_name": "Prasugrel",
"start_marketing_date": "20180622",
"active_numerator_strength": "10"
}Related drugs
Other records sharing ATC code B01AC22.
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