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United States · US · US:71610-527_5364ce21-e700-4cce-bd59-aadec2a56428
Clopidogrel
Orange BookUNIISPLATC B01AC04
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAphena Pharma Solutions - Tennessee, LLC
CountryUS (United States)
ATC codeB01AC04
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11716105276090 TABLET, FILM COATED in 1 BOTTLE (71610-527-60)
Annotations
UNII (FDA Substance ID)
08I79HTP27
CLOPIDOGREL BISULFATE
RxCUI 236991
Orange Book
A076274
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": "71610-527_5364ce21-e700-4cce-bd59-aadec2a56428",
"productndc": "71610-527",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "076274",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 75MG BASE",
"product_no": "001",
"approval_date": "May 17, 2012"
},
{
"rs": true,
"rld": false,
"te_code": "AB",
"strength": "EQ 300MG BASE",
"product_no": "002",
"approval_date": "Mar 4, 2014"
}
],
"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": "ANDA076274",
"marketing_category": "ANDA",
"nonproprietary_name": "clopidogrel bisulfate",
"start_marketing_date": "20120517",
"active_numerator_strength": "75"
}Related drugs
Other records sharing ATC code B01AC04.
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