FDA.reportPublic FDA data

NDC 0013-1114-01 - Cyklokapron

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
0013-1114
Requested NDC
0013-1114-01
Package NDCs from labels
0013-1114-01, 0013-1114-10, 0013-1114-20, 0013-1114-21, 0013-1114-15
Manufacturer
Pfizer Laboratories Div Pfizer Inc | Pfizer Manufacturing Belgium NV
Effective date
2025-09-03
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
WATER - Pfizer Laboratories Div Pfizer Inc | Pfizer Manufacturing Belgium NVPfizer Laboratories Div Pfizer Inc | Pfizer Manufacturing Belgium NV2025-09-03HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2013-03-03Indexing - Billing Unit

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0013-1114-01Cyklokapron10 mL in 1 AMPULEINJECTION, SOLUTION1034
0013-1114-10Cyklokapron10 in 1 BOXINJECTION, SOLUTION1034
0013-1114-10Cyklokapron1 in 1 CARTONINJECTION, SOLUTION134
0013-1114-15Cyklokapron1 in 1 CARTONINJECTION, SOLUTION134
0013-1114-20Cyklokapron10 mL in 1 VIALINJECTION, SOLUTION1034
0013-1114-21Cyklokapron10 in 1 BOXINJECTION, SOLUTION1034

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0013-1114CYKLOKAPRON (TRANEXAMIC ACID) INJECTION, SOLUTION [PFIZER LABORATORIES DIV PFIZER INC]33Current NDC, Legacy NDC, 6 package rows20250216_6e89a7d9-4da4-42aa-b7f8-c602c24eefe5.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0013-1114-01ML - Milliliter0013-1114141a6aa2-af9f-409b-b51c-20f5c9cf868c12013-03-03
0013-1114-10ML - Milliliter0013-11142511754e-d1c4-46a7-850c-45ee8019cbdc12012-07-24
0013-1114-15ML - Milliliter0013-1114ae013a09-b360-4dfc-b120-0f3a45417ee312018-12-13
0013-1114-20ML - Milliliter0013-1114e25156f3-3633-45dd-897a-8d434e799f8112015-04-03
0013-1114-21ML - Milliliter0013-1114657d3d16-276d-41b7-a707-ef3973abb67512015-04-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TRANEXAMIC ACIDACTIVE INGREDIENT6T84R30KC1CYKLOKAPRON (TRANEXAMIC ACID) INJECTION, SOLUTION [PHARMACIA AND UPJOHN COMPANY]13
TRANEXAMIC ACIDACTIVE MOIETY6T84R30KC1CYKLOKAPRON (TRANEXAMIC ACID) INJECTION, SOLUTION [PHARMACIA AND UPJOHN COMPANY]13
WATERINACTIVE INGREDIENT059QF0KO0RCYKLOKAPRON (TRANEXAMIC ACID) INJECTION, SOLUTION [PHARMACIA AND UPJOHN COMPANY]13

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 11 of 11 · 208 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Bach Original Flower RemediesWATERNelson Bach USA Limited09c76050-42c5-4403-865c-a1f6f668d9c02020-06-15WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERBaxter Healthcare Company8bcf5572-49e1-4302-9522-56f57904cb4a2019-12-29Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
TRANEXAMIC ACID IN SODIUM CHLORIDETRANEXAMIC ACIDExela Pharma Sciences, LLCdb36ddf2-4ac5-47ac-bdce-e3fa6983073e2019-04-22Warnings, Adverse reactionsExact identifier
unii: 6T84R30KC1
Dynamic Eyewash with EyecupWATERDynamic Safety International7d3af0f4-0e1f-9ea5-e053-2991aa0af7a22018-12-17WarningsExact identifier
unii: 059QF0KO0R
Bio Rock WaterROCK WATERBioActive Nutritional, Inc.178bd16d-0d4f-49d8-866b-8ab3a3c6889d2018-07-30WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERBaxter Healthcare Corporationef3e79c5-3f58-4b36-a296-64b7d9a651c12017-10-17Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Eye WashWATERCVS Pharmacy049cee29-7ec2-4d5b-8308-f522acde43a72017-03-29WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERBaxter Healthcare Company210dc9ab-d6ca-4552-ac19-1be17792d2902016-05-31Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.