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 4 of 11 · 209 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PUR-WASHWATERNiagara Pharmaceuticals Inc.7289103a-5cbf-42f4-8848-e827149a43ca2025-11-24WarningsExact identifier
unii: 059QF0KO0R
Eyewash Additive ConcentrateWATER AND PROPYLENE GLYCOLHaws Corporationdd168403-398c-41ff-b1df-d93e4ff39de32025-11-20WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERFresenius Kabi USA, LLCfd823bef-c14c-4708-a18a-8aaa8470412f2025-11-18Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Tranexamic AcidTRANEXAMIC ACIDAmneal Pharmaceuticals LLCa4d95a17-9745-4780-b4dc-8683df8ca5bd2025-11-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 6T84R30KC1
TRANEXAMIC ACIDTRANEXAMIC ACIDNorthstar Rx LLCfaa7c6bc-d7b9-48d5-9446-542a6a376db82025-11-13Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 6T84R30KC1
Eyesaline Eyewash ConcentratePURIFIED WATERHoneywell Safety Products USA, Inc.3765c251-eb14-d60f-e063-6294a90a6a4d2025-11-12WarningsExact identifier
unii: 059QF0KO0R
Eyesaline Emergency EyewashPURIFIED WATERHoneywell Safety Products USA, Inc.37f244fd-c02f-e66a-e063-6394a90aed812025-11-12WarningsExact identifier
unii: 059QF0KO0R
STERILE WATERWATERHenry Schein, Inc.f4087143-9868-4308-b96c-43657ee8ec282025-11-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Tranexamic AcidTRANEXAMIC ACIDXGen Pharmaceuticals DJB, Inc.1553f7eb-d5a8-4274-9762-5bcc5ffcf8092025-11-06Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 6T84R30KC1
Bacteriostatic WaterBACTERIOSTATIC WATERProPharma Distribution42c6938e-f747-ae13-e063-6294a90a59a32025-11-04Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERICU Medical Inc.aab10f03-26ae-4dbc-a481-ef025e48b4052025-11-02Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERICU Medical Inc.e3484bc6-ed7f-43ef-9d49-c131a8dff2dd2025-11-02Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERICU Medical Inc.1c0bbcb7-5ed6-4ee7-b297-080d3359474e2025-10-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Bacteriostatic WaterWATERHenry Schein, Inc.a833502e-a622-4e81-8c58-cef6ccb6c4c92025-10-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERBecton Dickinson and Companycab03cda-4660-4020-a3be-bf86242ff6642025-10-22Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Xpect EyewashEYEWASHCintas Corporation1d69365d-662b-4248-8fa9-1629451b549a2025-09-30WarningsExact identifier
unii: 059QF0KO0R
Tranexamic AcidTRANEXAMIC ACIDNordic Pharma, Inc.031bf7c2-3b07-469d-bc5a-31fc6238e25f2025-09-29Warnings, Adverse reactionsExact identifier
unii: 6T84R30KC1
CheBoho TEA TREE ACNECHEBOHO TEA TREE ACNEOpalshi(Guangzhou)E-commerce Co. Ltd.3fc4cf84-b2da-c593-e063-6394a90abc5c2025-09-27WarningsExact identifier
unii: 059QF0KO0R
TRANEXAMIC ACIDTRANEXAMIC ACIDBryant Ranch Prepack5b0c13fe-2c8e-4ac8-8bda-140881bd0cc42025-09-24Warnings, Adverse reactionsExact identifier
unii: 6T84R30KC1
Sterile WaterWATERProPharma Distribution3f2ae880-852f-b45d-e063-6394a90aa1cc2025-09-19Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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