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United States · US · US:42543-713_4b480542-0dd3-4694-9d43-d5fdcdd64a0f

Clopidogrel

Orange BookUNIISPLATC B01AC04

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

Identification

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

Packs · 5

  • ndc11
    4254371301
    100 TABLET in 1 BOTTLE (42543-713-01)
  • ndc11
    4254371305
    500 TABLET in 1 BOTTLE (42543-713-05)
  • ndc11
    4254371310
    1000 TABLET in 1 BOTTLE (42543-713-10)
  • ndc11
    4254371330
    30 TABLET in 1 BOTTLE (42543-713-30)
  • ndc11
    4254371390
    90 TABLET in 1 BOTTLE (42543-713-90)

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": "42543-713_4b480542-0dd3-4694-9d43-d5fdcdd64a0f",
  "productndc": "42543-713",
  "dosage_form": "TABLET",
  "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",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA204165",
  "marketing_category": "ANDA",
  "nonproprietary_name": "clopidogrel",
  "start_marketing_date": "20141101",
  "active_numerator_strength": "75"
}

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