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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
- ndc1100131114151 AMPULE in 1 CARTON (0013-1114-15) / 10 mL in 1 AMPULE (0013-1114-01)
- ndc11001311142110 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
Other records sharing ATC code B02AA02.
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