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United States · US · US:63739-178_2f97608b-b786-02f3-d5eb-5489e7069f8e

Clopidogrel bisulfate

Orange BookUNIISPLATC B01AC04

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

Identification

ManufacturerMcKesson Corporation dba SKY Packaging
CountryUS (United States)
ATC codeB01AC04
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6373917830
    5 BLISTER PACK in 1 CARTON (63739-178-30) / 6 TABLET, FILM COATED in 1 BLISTER PACK

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": "63739-178_2f97608b-b786-02f3-d5eb-5489e7069f8e",
  "productndc": "63739-178",
  "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": "20220818",
  "active_numerator_strength": "300"
}

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