Tranexamic Acid

Product NDC
67850-041
11-digit product format
678500041
Labeler code
67850
Product ID
67850-041_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
2018-10-11
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
67850-041-00ML - Milliliter67850-0418abcfc8d-cbfa-48be-8e56-ed377513b86912019-06-19
67850-041-10ML - Milliliter67850-041aa183fe8-11a0-4487-8d12-9f4946f07caa12019-06-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67850-041TRANEXAMIC ACID INJECTION, SOLUTION [METHAPHARM, INC.]11Legacy NDC20241208_3bb850aa-2061-4c30-848a-82871ff7bbf5.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
67850-041-106785000411010 VIAL, SINGLE-USE in 1 CARTON (67850-041-10) > 10 mL in 1 VIAL, SINGLE-USE (67850-041-00) 2018-10-110000-00-00NoNoCurrent