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United States · US · US:47335-894_2de2d0fb-68e7-4a22-8da8-be7658468f15

Clopidogrel Bisulfate

Orange BookUNIISPLATC B01AC04

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

Identification

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

Packs · 5

  • ndc11
    4733589413
    500 TABLET, FILM COATED in 1 BOTTLE (47335-894-13)
  • ndc11
    4733589418
    1000 TABLET, FILM COATED in 1 BOTTLE (47335-894-18)
  • ndc11
    4733589419
    90 TABLET, FILM COATED in 1 BOTTLE (47335-894-19)
  • ndc11
    4733589481
    90 TABLET, FILM COATED in 1 BOTTLE (47335-894-81)
  • ndc11
    4733589483
    30 TABLET, FILM COATED in 1 BOTTLE (47335-894-83)

Annotations

UNII (FDA Substance ID)
08I79HTP27
CLOPIDOGREL BISULFATE
RxCUI 236991
Orange Book
A090494
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": "47335-894_2de2d0fb-68e7-4a22-8da8-be7658468f15",
  "productndc": "47335-894",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "090494",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 75MG BASE",
        "product_no": "001",
        "approval_date": "May 17, 2012"
      }
    ],
    "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": "ANDA090494",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Clopidogrel Bisulfate",
  "start_marketing_date": "20120518",
  "active_numerator_strength": "75"
}

Related drugs

Other records sharing ATC code B01AC04.

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