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United States · US · US:42291-453_485d4436-cc9f-8ea9-e063-6294a90a53be

cilostazol

Orange BookUNIISPLATC B01AC23

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

Identification

ManufacturerAvKARE
CountryUS (United States)
ATC codeB01AC23
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    4229145360
    60 TABLET in 1 BOTTLE (42291-453-60)

Annotations

UNII (FDA Substance ID)
N7Z035406B
CILOSTAZOL
RxCUI 21107
Orange Book
A077030
ABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "N7Z035406B",
    "rxcui": "21107",
    "inchikey": "RRGUKTPIGVIEKM-UHFFFAOYSA-N",
    "display_name": "CILOSTAZOL",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "dc7c2c25-36a1-e3fd-e053-2995a90adabc": {
      "match": "brand_token",
      "title": "CILOSTAZOL TABLET [AVKARE]",
      "spl_version": "3",
      "published_date": "2026-01-16"
    }
  },
  "productid": "42291-453_485d4436-cc9f-8ea9-e063-6294a90a53be",
  "productndc": "42291-453",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "077030",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "50MG",
        "product_no": "001",
        "approval_date": "Dec 10, 2004"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "100MG",
        "product_no": "002",
        "approval_date": "Dec 10, 2004"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CILOSTAZOL",
  "proprietary_name": "cilostazol",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA077030",
  "marketing_category": "ANDA",
  "nonproprietary_name": "cilostazol",
  "start_marketing_date": "20220412",
  "active_numerator_strength": "100"
}

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