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United States · US · US:0378-5186_9e234352-49b7-46e3-bc59-acf63e0a7a14
Prasugrel
Orange BookUNIISPLATC B01AC22
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerMylan Pharmaceuticals Inc.
CountryUS (United States)
ATC codeB01AC22
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11037851869330 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-5186-93)
Annotations
UNII (FDA Substance ID)
G89JQ59I13
PRASUGREL HYDROCHLORIDE
RxCUI 847020
Orange Book
A205927
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": "0378-5186_9e234352-49b7-46e3-bc59-acf63e0a7a14",
"productndc": "0378-5186",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "205927",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 5MG BASE",
"product_no": "001",
"approval_date": "Jul 12, 2017"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 10MG BASE",
"product_no": "002",
"approval_date": "Jul 12, 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": "ANDA205927",
"marketing_category": "ANDA",
"nonproprietary_name": "Prasugrel",
"start_marketing_date": "20170815",
"active_numerator_strength": "10"
}Related drugs
Other records sharing ATC code B01AC22.
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