Tranexamic Acid

Product NDC
67850-042
11-digit product format
678500042
Labeler code
67850
Product ID
67850-042_f94b3514-bcf9-4bfc-bcb9-5d104e874cca
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tranexamic Acid
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Methapharm, Inc.
Application
ANDA202436
Marketing category
ANDA
Marketing start
2019-03-11
Marketing end
0000-00-00
Substance
TRANEXAMIC ACID
Active strength
100 mg/mL
Pharmacologic classes
Antifibrinolytic Agent [EPC], Decreased Fibrinolysis [PE]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67850-042-00ML - Milliliter67850-042bd1a0a1a-03ca-48b7-af4f-ec80e9718a2a12020-02-13
67850-042-10ML - Milliliter67850-042295d21c5-4e9f-4841-9abd-b14647dbce4712020-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67850-042TRANEXAMIC ACID INJECTION, SOLUTION [METHAPHARM, INC.]11Legacy NDC20241208_3bb850aa-2061-4c30-848a-82871ff7bbf5.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67850-042-106785000421010 AMPULE in 1 CARTON (67850-042-10) > 10 mL in 1 AMPULE (67850-042-00) 10 ampule2019-03-110000-00-00NoNoCurrent