FDA.reportPublic FDA data

NDC 42192-605-01 - Tranexamic Acid

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
42192-605
Requested NDC
42192-605-01
Package NDCs from labels
42192-605-01, 42192-605-10
Manufacturer
Acella Pharmaceuticals | ACIC Pharmaceuticals Inc.
Effective date
2018-11-30
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Tranexamic Acid - Acella Pharmaceuticals | ACIC Pharmaceuticals Inc.Acella Pharmaceuticals | ACIC Pharmaceuticals Inc.2018-11-30HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
42192-605-102023-09-19C16284748780-19d75b9d1-1c08-f424-e053-dadaa90a57cee8a45862-2187-49eb-892e-ade1b0cde938
42192-605-102020-01-31C16284748780-19d75b9d1-1c08-f424-e053-dadaa90a57cee8a45862-2187-49eb-892e-ade1b0cde938

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42192-605-01ML - Milliliter42192-60551301fb5-339d-44fe-89e5-b8870ad0223512014-07-02
42192-605-10ML - Milliliter42192-6056bc571a6-50f9-4604-96da-448854eda2ef12014-07-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TRANEXAMIC ACIDACTIVE INGREDIENT6T84R30KC1TRANEXAMIC ACID INJECTION, SOLUTION [ACELLA PHARMACEUTICALS]1
TRANEXAMIC ACIDACTIVE MOIETY6T84R30KC1TRANEXAMIC ACID INJECTION, SOLUTION [ACELLA PHARMACEUTICALS]1
waterINACTIVE INGREDIENT059QF0KO0RTRANEXAMIC ACID INJECTION, SOLUTION [ACELLA PHARMACEUTICALS]1

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 5 of 11 · 209 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tranexamic AcidTRANEXAMIC ACIDSagent Pharmaceuticalsb28a18a4-391d-48ab-8fa5-6391f15553f32025-09-19Warnings, Adverse reactionsExact identifier
unii: 6T84R30KC1
Tranexamic AcidTRANEXAMIC ACIDANI Pharmaceuticals, Inc.82bc4879-bcf5-47c4-8636-a73c4e7d0de92025-09-19Warnings, Adverse reactionsExact identifier
unii: 6T84R30KC1
Medi-First First Aid Eye WashPURIFIED WATERUnifirst First Aid Corporationdcd7fe56-ff5c-4c8d-a415-6e363d7e53f42025-09-08WarningsExact identifier
unii: 059QF0KO0R
Green Guard First Aid Eye WashWATERUnifirst First Aid Corporationa4ba5526-b4e2-4bcc-9127-aa22ebf5017f2025-09-08WarningsExact identifier
unii: 059QF0KO0R
Medi-First Plus First Aid Eye WashWATERUnifirst First Aid Corporationd7ea80ca-b4a0-4476-8b50-b3425c6d456a2025-09-08WarningsExact identifier
unii: 059QF0KO0R
ECOLAB Eye WashPURIFIED WATERECOLAB Food Safety Specialties, Inc.4bcfa21a-791e-4d04-e054-00144ff88e882025-09-08WarningsExact identifier
unii: 059QF0KO0R
Tranexamic AcidTRANEXAMIC ACIDMylan Institutional LLC6f033f1e-8c78-4c87-b870-6493944315ff2025-09-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 6T84R30KC1
Physicians Care EyewashEYEWASHAcme United Corporation3e239b12-9a75-339d-e063-6294a90a72ae2025-09-06WarningsExact identifier
unii: 059QF0KO0R
CyklokapronTRANEXAMIC ACIDPfizer Laboratories Div Pfizer Inc6e89a7d9-4da4-42aa-b7f8-c602c24eefe52025-09-03Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 6T84R30KC1
Sterile WaterWATER INJECTIONHenry Schein, Inc.3501952b-b556-4d5e-b81b-5c35ff87b4752025-08-28Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
tranexamic acidTRANEXAMIC ACIDProvepharm Inc.1b8c3500-8e87-4b6e-b6a9-8da5f9c008202025-08-12Warnings, Adverse reactionsExact identifier
unii: 6T84R30KC1
TRANEXAMIC ACIDTRANEXAMIC ACIDDr. Reddy's Laboratories Inc.e5a52dad-e328-48f2-9182-4df46f5572ef2025-08-01Warnings, Adverse reactionsExact identifier
unii: 6T84R30KC1
Tranexamic AcidTRANEXAMIC ACIDActavis Pharma, Inc.3f07e93b-3568-487e-894f-8f90e5a0960a2025-07-15Warnings, Adverse reactionsExact identifier
unii: 6T84R30KC1
Sterile WaterSTERILE WATERNephron Pharmaceuticals Corporationbc04a883-babc-87a6-e053-2995a90a3dfd2025-07-11Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Plaque identifyingPLAQUE IDENTIFYINGShenzhen Yagao Technology Co., Ltd.37eeb656-22f1-7372-e063-6394a90ad0412025-06-19WarningsExact identifier
unii: 059QF0KO0R
TRANEXAMIC ACID IN SODIUM CHLORIDETRANEXAMIC ACIDAmneal Pharmaceuticals Private Limited615a9bec-f769-4774-8b05-22473b93668c2025-05-30Warnings, Adverse reactionsExact identifier
unii: 6T84R30KC1
Sterile WaterWATERHenry Schein, Inc.88403fcf-a276-42c0-88b6-bd84a720b5642025-05-29Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Eyesaline Emergency EyewashSTERILE EYESALINE EYEWASHHoneywell Safety Products USA, Inc.2d567518-4c54-7448-e063-6294a90a3e642025-05-14WarningsExact identifier
unii: 059QF0KO0R
Eye WashWATERCMC Group Inc.6158a1f5-a6bc-4a3e-9d1d-0a310d9dc5612025-04-02WarningsExact identifier
unii: 059QF0KO0R
tranexamic acid in sodium chlorideTRANEXAMIC ACIDAvenacy Inc.c3aad84a-aa99-42a0-b4b6-6fdee7585e192025-03-28Warnings, Adverse reactionsExact identifier
unii: 6T84R30KC1

Reported adverse events (FAERS/openFDA)#

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