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United States · US · US:55111-671_e74780f8-a035-e6a0-b457-c04edd4162bf

Clopidogrel bisulfate

Orange BookUNIISPLATC B01AC04

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

Identification

ManufacturerDr.Reddy's Laboratories Limited
CountryUS (United States)
ATC codeB01AC04
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 8

  • ndc11
    5511167101
    100 TABLET, FILM COATED in 1 BOTTLE (55111-671-01)
  • ndc11
    5511167105
    500 TABLET, FILM COATED in 1 BOTTLE (55111-671-05)
  • ndc11
    5511167130
    30 TABLET, FILM COATED in 1 BOTTLE (55111-671-30)
  • ndc11
    5511167131
    5 BLISTER PACK in 1 CARTON (55111-671-31) / 6 TABLET, FILM COATED in 1 BLISTER PACK (55111-671-06)
  • ndc11
    5511167148
    1 BLISTER PACK in 1 CARTON (55111-671-48) / 4 TABLET, FILM COATED in 1 BLISTER PACK
  • ndc11
    5511167178
    10 BLISTER PACK in 1 CARTON (55111-671-78) / 10 TABLET, FILM COATED in 1 BLISTER PACK (55111-671-79)
  • ndc11
    5511167181
    3 BLISTER PACK in 1 CARTON (55111-671-81) / 10 TABLET, FILM COATED in 1 BLISTER PACK (55111-671-79)
  • ndc11
    5511167190
    90 TABLET, FILM COATED in 1 BOTTLE (55111-671-90)

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": "55111-671_e74780f8-a035-e6a0-b457-c04edd4162bf",
  "productndc": "55111-671",
  "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": "20120517",
  "active_numerator_strength": "300"
}

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