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United States · US · US:0615-8625_4c94d725-7d0f-41ea-b853-b292af783896

Clopidogrel bisulfate

Orange BookUNIISPLATC B01AC04

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

Identification

ManufacturerNCS HealthCare of KY, LLC dba Vangard Labs
CountryUS (United States)
ATC codeB01AC04
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 4

  • ndc11
    0615862505
    15 TABLET, FILM COATED in 1 BLISTER PACK (0615-8625-05)
  • ndc11
    0615862507
    7 TABLET, FILM COATED in 1 BLISTER PACK (0615-8625-07)
  • ndc11
    0615862530
    6 BLISTER PACK in 1 BOX, UNIT-DOSE (0615-8625-30) / 5 TABLET, FILM COATED in 1 BLISTER PACK
  • ndc11
    0615862539
    30 TABLET, FILM COATED in 1 BLISTER PACK (0615-8625-39)

Annotations

UNII (FDA Substance ID)
08I79HTP27
CLOPIDOGREL BISULFATE
RxCUI 236991
Orange Book
A204165
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": "0615-8625_4c94d725-7d0f-41ea-b853-b292af783896",
  "productndc": "0615-8625",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "204165",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 75MG BASE",
        "product_no": "001",
        "approval_date": "Sep 15, 2014"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 300MG BASE",
        "product_no": "002",
        "approval_date": "Sep 15, 2014"
      }
    ],
    "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": "ANDA204165",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Clopidogrel bisulfate",
  "start_marketing_date": "20150915",
  "active_numerator_strength": "75"
}

Related drugs

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