Tranexamic Acid

Product NDC
70860-400
11-digit product format
708600400
Labeler code
70860
Product ID
70860-400_965bbf85-2808-4653-9f61-649d9667b52c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
tranexamic acid
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Athenex Pharmaceutical Division, LLC.
Application
ANDA207239
Marketing category
ANDA
Marketing start
2017-03-27
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
2022-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70860-400-102024-03-05C16284748780-11030e365-4043-111a-e063-dadaa90a10e2d6cd2be1-2333-4c8a-912f-bd7d968a8e61
70860-400-102024-01-30C16284748780-11030e365-4043-111a-e063-dadaa90a10e2d6cd2be1-2333-4c8a-912f-bd7d968a8e61

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70860-400-10ML - Milliliter70860-4003e95a358-45dc-4bb5-a71a-a1d0a42f496a12017-07-07
70860-400-41ML - Milliliter70860-400a003debf-ac71-4135-9c56-787cd1028c4212019-04-11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70860-400-107086004001010 VIAL in 1 CARTON (70860-400-10) > 10 mL in 1 VIAL (70860-400-41) 10 vial2017-03-270000-00-00NoNoCurrent