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United States · US · US:82009-182_b225308c-50b5-6c91-fc03-1506c1b2dedc
Clopidogrel bisulfate
Orange BookUNIISPLATC B01AC04
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerQuallent Pharmaceuticals Health LLC
CountryUS (United States)
ATC codeB01AC04
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc118200918205500 TABLET, FILM COATED in 1 BOTTLE (82009-182-05)
Annotations
UNII (FDA Substance ID)
08I79HTP27
CLOPIDOGREL BISULFATE
RxCUI 236991
Orange Book
A091023
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": "82009-182_b225308c-50b5-6c91-fc03-1506c1b2dedc",
"productndc": "82009-182",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "091023",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 300MG BASE",
"product_no": "001",
"approval_date": "May 17, 2012"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 75MG BASE",
"product_no": "002",
"approval_date": "Aug 5, 2024"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "CLOPIDOGREL BISULFATE",
"proprietary_name": "Clopidogrel bisulfate",
"active_ingred_unit": "mg/1",
"application_number": "ANDA091023",
"marketing_category": "ANDA",
"nonproprietary_name": "Clopidogrel bisulfate",
"start_marketing_date": "20250905",
"active_numerator_strength": "75"
}Related drugs
Other records sharing ATC code B01AC04.
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