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United States · US · US:52605-083_9e3256b5-2032-4615-967d-449d49b09921
Clopidogrel
Orange BookUNIISPLATC B01AC04
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerPOLYGEN PHARMACEUTICALS INC.
CountryUS (United States)
ATC codeB01AC04
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc115260508305500 TABLET in 1 BOTTLE, DISPENSING (52605-083-05)
- ndc11526050831330 TABLET in 1 BOTTLE (52605-083-13)
Annotations
UNII (FDA Substance ID)
08I79HTP27
CLOPIDOGREL BISULFATE
RxCUI 236991
Orange Book
A213351
ABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "08I79HTP27",
"rxcui": "236991",
"inchikey": "FDEODCTUSIWGLK-RSAXXLAASA-N",
"display_name": "CLOPIDOGREL BISULFATE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"c03a895c-2d74-4d7f-891f-b752ce409b68": {
"match": "brand_token",
"title": "CLOPIDOGREL (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [CARDINAL HEALTH 107, LLC]",
"spl_version": "3",
"published_date": "2026-04-30"
}
},
"productid": "52605-083_9e3256b5-2032-4615-967d-449d49b09921",
"productndc": "52605-083",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "213351",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 75MG BASE",
"product_no": "001",
"approval_date": "Jul 17, 2020"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 300MG BASE",
"product_no": "002",
"approval_date": "Jul 17, 2020"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "CLOPIDOGREL BISULFATE",
"proprietary_name": "Clopidogrel",
"active_ingred_unit": "mg/1",
"application_number": "ANDA213351",
"marketing_category": "ANDA",
"nonproprietary_name": "Clopidogrel",
"start_marketing_date": "20210301",
"active_numerator_strength": "300"
}Related drugs
Other records sharing ATC code B01AC04.
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