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United States · US · US:0024-1171_ed60a9e7-49f4-469c-bb7a-08e1bb6057e2

Plavix

Orange BookUNIISPLATC B01AC04

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerSanofi-Aventis U.S. LLC
CountryUS (United States)
ATC codeB01AC04
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 0

No packs registered.

Annotations

UNII (FDA Substance ID)
08I79HTP27
CLOPIDOGREL BISULFATE
RxCUI 236991
Orange Book
N020839
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": {
    "de8b0b67-eb25-4684-83b5-7ad785314227": {
      "match": "brand_token",
      "title": "PLAVIX (CLOPIDOGREL) TABLET, FILM COATED [SANOFI-AVENTIS U.S. LLC]",
      "spl_version": "5",
      "published_date": "2025-06-11"
    }
  },
  "productid": "0024-1171_ed60a9e7-49f4-469c-bb7a-08e1bb6057e2",
  "productndc": "0024-1171",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "020839",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "EQ 75MG BASE",
        "product_no": "001",
        "approval_date": "Nov 17, 1997"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "EQ 300MG BASE",
        "product_no": "002",
        "approval_date": "Sep 20, 2007"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CLOPIDOGREL BISULFATE",
  "proprietary_name": "Plavix",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA020839",
  "marketing_category": "NDA",
  "nonproprietary_name": "clopidogrel",
  "start_marketing_date": "19971117",
  "active_numerator_strength": "75"
}

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