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 6 of 11 · 208 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Bestmade Natural Products Field of Flowers FormulaAESCULUS CAR, AESCULUS HIP, AGRIMONIA EUP, BROMUS RAM, CALLUNA VULG, CARPINUS BET, CASTANEA SAT, CENTAURIUM UMB, CERATOSTIGMA WILLM, CICHORIUM INT, CLEMATIS VIT, FAGUS SYLV, GENTIANELLA AMARELLA, HELIANTHEMUM NUMMULARIUM, ILEX AQUIFOLIUM, IMPATIENS GLAND, LARIX DECIDUA, LONICERA CAPRIFOLIUM, MALUS, MIMULUS GUT, OLEA EUROP, ORNITHOGALUM UMB, PINUS SYL, POPULUS TREM, PRUNUS CERA, QUERCUS ROB, ROCK WATER, ROSA CAN, SALIX VIT, SCLERANTHUS ANNNUS, SINAPIS ARV, ULEX EURO, ULMUS PROC, VERBENA, VITIS VINBestmade Natural Products2fbf9b7c-e54f-589d-e063-6394a90a14a72025-03-07WarningsExact identifier
unii: 059QF0KO0R
TRANEXAMIC ACIDTRANEXAMIC ACIDProficient Rx LP416cdb61-31fb-4554-835f-a7744aa33b612025-03-01Warnings, Adverse reactionsExact identifier
unii: 6T84R30KC1
Tranexamic AcidTRANEXAMIC ACIDNexus Pharmaceuticals LLCc479dccd-15c6-47c2-9675-680ebb9db2cb2025-02-26Warnings, Adverse reactionsExact identifier
unii: 6T84R30KC1
AeroWash EyewashEYEWASH SOLUTIONAero Healthcare US LLCa477de08-4301-0ee5-e053-2995a90af79d2025-02-26WarningsExact identifier
unii: 059QF0KO0R
Advanced Eye Relief Eye WashWATER SOLUTIONBausch & Lomb Incorporated9caccce1-4530-441d-bf76-244edeb9dedc2025-02-17WarningsExact identifier
unii: 059QF0KO0R
Eyesaline Eyewash ConcentratePURIFIED WATERHoneywell Safety Products, Inc.2d90c8e8-f479-3535-e063-6394a90af1222025-02-07WarningsExact identifier
unii: 059QF0KO0R
Bestmade Natural Products BM63CEANOTHUS, KALI MUR, KALI ARS, OOPHRINUM, SELENIUM, THALLIUM, WEISBADENBestmade Natural Products2cea4552-3700-3da3-e063-6294a90a14b52025-01-30WarningsExact identifier
unii: 059QF0KO0R
Medics Choice Soothing Eye WashPURIFIED WATERKC Pharmaceuticals, Inc.10e49808-161e-f4ec-e063-6294a90a17752025-01-19WarningsExact identifier
unii: 059QF0KO0R
Tranexamic Acid in Sodium ChlorideTRANEXAMIC ACIDHP Halden Pharma AS0c638812-ba60-49fe-a715-f40246b6cbf72025-01-14Warnings, Adverse reactionsExact identifier
unii: 6T84R30KC1
STERILE WATERSTERILE WATERHF Acquisition Co. LLC, DBA HealthFirst74ed2a6f-824c-a1ff-e053-2a91aa0a57c02025-01-09Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
STERILE WATERSTERILE WATERHF Acquisition Co LLC, DBA HealthFirst77bd3c0f-f4ab-7cfa-e053-2a91aa0a1b832025-01-09Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
STERILE WATERSTERILE WATERHF Acquisition Co LLC, DBA HealthFirst7610bf80-61b7-982f-e053-2a91aa0ac1bb2025-01-09Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
T-27WATERDNA Labs, Inc.f0e9afd7-64a4-4b85-9c5f-4bf07ba4b4812025-01-09WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterSTERILE WATER FOR INJECTIONMedefil, Inc.99e99a50-82d5-aff6-e053-2a95a90a8c562025-01-08Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
BACTERIOSTATIC WATERBACTERIOSTATIC WATERHF Acquisition Co LLC, DBA HealthFirst99b0ef9b-600a-40dc-e053-2a95a90aa07e2025-01-08Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
STERILE WATERSTERILE WATERHF Acquisition Co LLC, DBA HealthFirst99b1cb12-0b2d-0c0f-e053-2a95a90ac3b62025-01-08Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Tranexamic AcidTRANEXAMIC ACIDCaplin Steriles Limited6326bdbf-fb2e-451a-a0a0-7d0b59ce54382025-01-03Warnings, Adverse reactionsExact identifier
rxcui: 238720
unii: 6T84R30KC1
Fendall Pure FlowPURIFIED WATERHoneywell Safety Products USA, Inc.afda6fc3-7615-b0be-e053-2995a90a62082024-12-10WarningsExact identifier
unii: 059QF0KO0R
PhysiciansCare Ophthalmic Solution Eyewash Purified Water, 98.3%PURIFIED WATER 98.3%Acme United Corporation9248ee71-2d47-620d-e053-2995a90af5c82024-11-26WarningsExact identifier
unii: 059QF0KO0R
PhysiciansCare Ophthalmic Solution EyewashPURIFIED WATER 98.3%Acme United Corporationcca454e0-b2bd-4215-bc06-426fcc3f7bd62024-11-26WarningsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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