tranexamic acid

Product NDC
61990-0611
11-digit product format
619900611
Labeler code
61990
Product ID
61990-0611_1d73ec0a-9f83-e2e4-8acb-3c9c3115eb3d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tranexamic Acid
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Apollo Pharmaceuticals Inc.
Application
ANDA212676
Marketing category
ANDA
Marketing start
2019-09-30
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
2021-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61990-0611-22023-03-28C16284748780-1f386c649-c107-0266-e053-dadaa90a7c1aa30cd382-4e2a-428d-a6d1-a530f4d230c1
61990-0611-22023-01-30C16284748780-1f386c649-c107-0266-e053-dadaa90a7c1aa30cd382-4e2a-428d-a6d1-a530f4d230c1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61990-0611-0ML - Milliliter61990-061192912dd4-6655-4322-8aac-d3f5d980aade12019-11-12
61990-0611-2ML - Milliliter61990-0611d603359e-2ba9-4e26-b627-4f89fd64222a12019-11-12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
61990-0611-26199006110210 VIAL, SINGLE-DOSE in 1 CARTON (61990-0611-2) > 10 mL in 1 VIAL, SINGLE-DOSE (61990-0611-0) 2019-09-300000-00-00NoNoCurrent