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 2 of 11 · 209 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Fendall 2000 Pure FlowPURIFIED WATERHoneywell Safety Products USA, Inc.37dead3e-60cb-88ae-e063-6294a90a8f702026-06-24WarningsExact identifier
unii: 059QF0KO0R
Bacteriostatic WaterBACTERIOSTATIC WATERFujian Genohope Biotech Ltd.54f66b82-c9e5-a2bc-e063-6394a90adbbc2026-06-23Exact identifier
unii: 059QF0KO0R
HumalogINSULIN LISPROEli Lilly and Companyc8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f2026-06-16Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
BM BM70 DROPSANTIM CURD, FERR MET, PHOSPHORUS, SULPHUR, WIESBADEN, THUJA, VERATRUM ALBTotal Operations Management LLC DBA:Bestmade Natural Products Micro54113d1f-e8e7-6b4c-e063-6394a90a0edf2026-06-12WarningsExact identifier
unii: 059QF0KO0R
BM BM70 DROPSANTIM CURD, FERR MET, PHOSPHORUS, SULPHUR, WIESBADEN, THUJA, VERATRUM ALBBM Private Limited53fa21d9-1f80-2e69-e063-6394a90ab9f32026-06-11WarningsExact identifier
unii: 059QF0KO0R
XIMONTH Fungi Free Bee Venom Nail Soothing SerumGLYCERINShantou Ximonth Biotechnology Co., Ltd.53bab969-8407-6334-e063-6294a90aa5d12026-06-08WarningsExact identifier
unii: 059QF0KO0R
Tranexamic AcidTRANEXAMIC ACIDHeritage Pharmaceuticals Labs Inc. d/b/a Avet Pharmaceuticals Labs Inc.28ccedba-99cd-49f3-a782-798df52585242026-05-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 6T84R30KC1
Bacteriostatic WaterBACTERIOSTATIC WATERHospira, Inc.87d6e9dc-fe3b-4593-ac9a-d7493d1959c72026-05-22Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
WHITENING SUNSCREENANTI WRINKLEWHITENING SUNSCREENANTI WRINKLEShantou Oushiya Biotechnology Co.,Ltd524384e9-b3f8-4c13-e063-6394a90a89732026-05-20WarningsExact identifier
unii: 059QF0KO0R
TRANEXAMIC ACIDTRANEXAMIC ACIDNorthStar Rx LLC4877eacd-fda7-4708-93a5-81052c1d2e142026-05-13Warnings, Adverse reactionsExact identifier
unii: 6T84R30KC1
Tranexamic AcidTRANEXAMIC ACIDHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.4f42a81c-37e3-4b57-8e9a-d42c55bbfc522026-05-12Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA202436
unii: 6T84R30KC1
Sterile WaterWATERHospira, Inc.3a6422e1-feee-4095-8883-2b0837039e6e2026-05-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Multi FlowerAESCULUS CARNEA, FLOS, AESCULUS HIPPOCASTANUM, FLOS, AGRIMONIA EUPATORIA, FLOS, BROMUS RAMOSUS, FLOS, CALLUNA VULGARIS, FLOS, CARPINUS BETULUS , FLOS, CASTANEA SATIVA, FLOS, CENTAURIUM UMBELLATUM, FLOS, CERATOSTIGMA WILLMOTTIANUM, FLOS, CICHORIUM INTYBUS, FLOS, CLEMATIS VITALBA, FLOS, CLEMATIS VITALBA, FLOS, FAGUS SYLVATICA, FLOS, GENTIANELLA AMARELLA, FLOS, HELIANTHEMUM NUMMULARIUM, FLOS, ILEX AQUIFOLIUM, FLOS, IMPATIENS GLANDULIFERA, FLOS, LARIX DECIDUA, FLOS, LONICERA CAPRIFOLIUM, FLOSEnergique, Inc.09c059e7-f748-402c-8447-af5b61169c582026-05-06WarningsExact identifier
unii: 059QF0KO0R
Tranexamic AcidTRANEXAMIC ACIDHeritage Pharmaceuticals Labs Inc. d/b/a Avet Pharmaceuticals Labs Inc.d5f55a98-aeb8-47e1-9154-87ba702220272026-04-10Warnings, Adverse reactionsExact identifier
unii: 6T84R30KC1
KIDS TOOTHPASTE, FOR CAVITY PROTECTIONKIDS TOOTHPASTE FOR CAVITY PROTECTIONShulisa (Foshan) Daily ChemicalIndustry Co., Ltd4e8fab9e-f05c-5e2f-e063-6294a90aecf92026-04-03WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERHospira, Inc.2b9ea23a-f9e9-48a8-25b7-519e3bbd68282026-03-18Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
TINTED SUNSCREEN FOUNDATIONTINTED SUNSCREEN FOUNDATIONGuanghzou AiXin Biotech Co Ltd396393c4-b50c-3877-e063-6294a90a0e9b2026-03-17WarningsExact identifier
unii: 059QF0KO0R
2-Pack Facial Serum2-PACK FACIAL SERUMGuangzhou Ariel Biotech Co., Ltd.27c7f645-cfb3-6db1-e063-6394a90a42ff2026-03-06WarningsExact identifier
unii: 059QF0KO0R
Tranexamic AcidTRANEXAMIC ACIDAmerican Health Packagingcbc6f5b3-927e-4a94-8836-dbcd47ef97a82026-03-03Warnings, Adverse reactionsExact identifier
unii: 6T84R30KC1
INSULIN DILUTING MEDIUM FOR KirstyWATERBiocon Biologics Inc.3db1d482-7e1f-aec6-79ef-3f305b4d82772026-01-20Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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