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United States · US · US:0904-6467_188c5658-7bc2-4331-a794-a2194863953c

Clopidogrel

Orange BookUNIISPLATC B01AC04

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

Identification

ManufacturerMajor Pharmaceuticals
CountryUS (United States)
ATC codeB01AC04
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    0904646707
    30 BLISTER PACK in 1 CARTON (0904-6467-07) / 1 TABLET, FILM COATED in 1 BLISTER PACK
  • ndc11
    0904646710
    20 BLISTER PACK in 1 CARTON (0904-6467-10) / 1 TABLET, FILM COATED in 1 BLISTER PACK

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": "0904-6467_188c5658-7bc2-4331-a794-a2194863953c",
  "productndc": "0904-6467",
  "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": "20150406",
  "active_numerator_strength": "300"
}

Related drugs

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