Clopidogrel

Orange BookUNIISPLATC B01AC04

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerProficient Rx LP

CountryUS (United States)

ATC codeB01AC04

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 8

ndc11
8280498600
100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (82804-986-00)
ndc11
8280498630
30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (82804-986-30)
ndc11
8280498655
500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (82804-986-55)
ndc11
8280498660
60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (82804-986-60)
ndc11
8280498664
240 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (82804-986-64)
ndc11
8280498672
120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (82804-986-72)
ndc11
8280498678
180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (82804-986-78)
ndc11
8280498690
90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (82804-986-90)

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": "82804-986_330702d9-842c-416d-9b11-b4a9b707e9b2",
  "productndc": "82804-986",
  "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",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA204165",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Clopidogrel Bisulfate",
  "start_marketing_date": "20180727",
  "active_numerator_strength": "300"
}

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