cyklokapron

Generic: tranexamic acid

Labeler: pfizer laboratories div pfizer inc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name cyklokapron
Generic Name tranexamic acid
Labeler pfizer laboratories div pfizer inc
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

tranexamic acid 100 mg/mL

Manufacturer
Pfizer Laboratories Div Pfizer Inc

Identifiers & Regulatory

Product NDC 0013-1114
Product ID 0013-1114_9776ef50-2235-40ba-9245-de06f7b4d019
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA019281
Listing Expiration 2026-12-31
Marketing Start 1986-12-30

Pharmacologic Class

Established (EPC)
antifibrinolytic agent [epc]
Physiologic Effect
decreased fibrinolysis [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00131114
Hyphenated Format 0013-1114

Supplemental Identifiers

RxCUI
208104 238720
UPC
0300131114103
UNII
6T84R30KC1
NUI
N0000175634 N0000175632

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name cyklokapron (source: ndc)
Generic Name tranexamic acid (source: ndc)
Application Number NDA019281 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 100 mg/mL
source: ndc
Packaging
  • 1 AMPULE in 1 CARTON (0013-1114-15) / 10 mL in 1 AMPULE (0013-1114-01)
  • 10 VIAL in 1 BOX (0013-1114-21) / 10 mL in 1 VIAL (0013-1114-20)
source: ndc

Packages (2)

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

Ingredients (1)

tranexamic acid (100 mg/mL)

Linked Drug Pages (1)

Cyklokapron ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "9776ef50-2235-40ba-9245-de06f7b4d019", "openfda": {"nui": ["N0000175634", "N0000175632"], "upc": ["0300131114103"], "unii": ["6T84R30KC1"], "rxcui": ["208104", "238720"], "spl_set_id": ["6e89a7d9-4da4-42aa-b7f8-c602c24eefe5"], "pharm_class_pe": ["Decreased Fibrinolysis [PE]"], "pharm_class_epc": ["Antifibrinolytic Agent [EPC]"], "manufacturer_name": ["Pfizer Laboratories Div Pfizer Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 AMPULE in 1 CARTON (0013-1114-15)  / 10 mL in 1 AMPULE (0013-1114-01)", "package_ndc": "0013-1114-15", "marketing_start_date": "20181121"}, {"sample": false, "description": "10 VIAL in 1 BOX (0013-1114-21)  / 10 mL in 1 VIAL (0013-1114-20)", "package_ndc": "0013-1114-21", "marketing_start_date": "19861230"}], "brand_name": "Cyklokapron", "product_id": "0013-1114_9776ef50-2235-40ba-9245-de06f7b4d019", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Antifibrinolytic Agent [EPC]", "Decreased Fibrinolysis [PE]"], "product_ndc": "0013-1114", "generic_name": "tranexamic acid", "labeler_name": "Pfizer Laboratories Div Pfizer Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Cyklokapron", "active_ingredients": [{"name": "TRANEXAMIC ACID", "strength": "100 mg/mL"}], "application_number": "NDA019281", "marketing_category": "NDA", "marketing_start_date": "19861230", "listing_expiration_date": "20261231"}