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United States · US · US:16714-052_dbf6d86e-5d4f-40da-a933-b928843053b7

Clopidogrel

Orange BookUNIISPLATC B01AC04

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

Identification

ManufacturerNorthStar RxLLC
CountryUS (United States)
ATC codeB01AC04
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 6

  • ndc11
    1671405201
    30 TABLET in 1 BOTTLE (16714-052-01)
  • ndc11
    1671405202
    90 TABLET in 1 BOTTLE (16714-052-02)
  • ndc11
    1671405203
    500 TABLET in 1 BOTTLE (16714-052-03)
  • ndc11
    1671405204
    1000 TABLET in 1 BOTTLE (16714-052-04)
  • ndc11
    1671405210
    10 TABLET in 1 BLISTER PACK (16714-052-10)
  • ndc11
    1671405211
    100 TABLET in 1 BOX, UNIT-DOSE (16714-052-11)

Annotations

UNII (FDA Substance ID)
08I79HTP27
CLOPIDOGREL BISULFATE
RxCUI 236991
Orange Book
A202928
AB
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": "16714-052_dbf6d86e-5d4f-40da-a933-b928843053b7",
  "productndc": "16714-052",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "202928",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 75MG BASE",
        "product_no": "001",
        "approval_date": "Feb 10, 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": "ANDA202928",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Clopidogrel",
  "start_marketing_date": "20220809",
  "active_numerator_strength": "75"
}

Related drugs

Other records sharing ATC code B01AC04.

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