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United States · US · US:0013-1114_9776ef50-2235-40ba-9245-de06f7b4d019

Cyklokapron

Orange BookUNIISPLATC B02AA02

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

Identification

ManufacturerPfizer Laboratories Div Pfizer Inc
CountryUS (United States)
ATC codeB02AA02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    0013111415
    1 AMPULE in 1 CARTON (0013-1114-15) / 10 mL in 1 AMPULE (0013-1114-01)
  • ndc11
    0013111421
    10 VIAL in 1 BOX (0013-1114-21) / 10 mL in 1 VIAL (0013-1114-20)

Annotations

UNII (FDA Substance ID)
6T84R30KC1
TRANEXAMIC ACID
RxCUI 10691
Orange Book
N019281
AP
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "6T84R30KC1",
    "rxcui": "10691",
    "inchikey": "GYDJEQRTZSCIOI-LJGSYFOKSA-N",
    "display_name": "TRANEXAMIC ACID",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "6e89a7d9-4da4-42aa-b7f8-c602c24eefe5": {
      "match": "brand_token",
      "title": "CYKLOKAPRON (TRANEXAMIC ACID) INJECTION, SOLUTION [PFIZER LABORATORIES DIV PFIZER INC]",
      "spl_version": "34",
      "published_date": "2025-09-08"
    }
  },
  "productid": "0013-1114_9776ef50-2235-40ba-9245-de06f7b4d019",
  "productndc": "0013-1114",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "019281",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "100MG/ML",
        "product_no": "001",
        "approval_date": "Dec 30, 1986"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "TRANEXAMIC ACID",
  "proprietary_name": "Cyklokapron",
  "active_ingred_unit": "mg/mL",
  "application_number": "NDA019281",
  "marketing_category": "NDA",
  "nonproprietary_name": "tranexamic acid",
  "start_marketing_date": "19861230",
  "active_numerator_strength": "100"
}

Related drugs

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