FDA.reportPublic FDA data

Tranexamic Acid

Product NDC
25021-415
11-digit product format
250210415
Labeler code
25021
Product ID
25021-415_3fd920b8-1b08-4882-9ed4-dd1b5b52af94
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tranexamic Acid
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Sagent Pharmaceuticals
Application
ANDA207239
Marketing category
ANDA
Marketing start
2023-07-15
Substance
TRANEXAMIC ACID
Active strength
100 mg/mL
Pharmacologic classes
Antifibrinolytic Agent [EPC], Decreased Fibrinolysis [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Tranexamic Acid
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TRANEXAMIC ACID100 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6T84R30KC1
Rxcui238720

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
8234c772-5c41-424c-a33e-e06e8c4de9c1Product name220250626
fbe2ea47-480e-f5f1-0d64-c87fd5ac923bProduct name420250224
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
510b43a3-8143-a25f-19c6-476c90dbb618Product name920171115

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
25021-415-10Tranexamic Acid10 mL in 1 VIALINJECTION, SOLUTION101
25021-415-10Tranexamic Acid10 in 1 CARTONINJECTION, SOLUTION101
25021-415-66Tranexamic Acid10 mL in 1 VIALINJECTION, SOLUTION101
25021-415-66Tranexamic Acid10 in 1 CARTONINJECTION, SOLUTION101

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
25021-415-10ML - Milliliter25021-415d95611a4-dab5-4ac0-9a71-6ebbd209e1c412023-09-05
25021-415-66ML - Milliliter25021-415e996cbe3-cf68-4eaf-bbc0-c7d1a8bdc15a12025-11-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
25021-415TRANEXAMIC ACID INJECTION, SOLUTION [SAGENT PHARMACEUTICALS]1Current NDC, 2 package rows20230715_0277db2d-7c81-4cd0-ac19-fa12b5721428.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
238720tranexamic acid 1000 MG in 10 ML InjectionPSN0277db2d-7c81-4cd0-ac19-fa12b57214281
238720tranexamic acid 1000 MG in 10 ML InjectionPSNb28a18a4-391d-48ab-8fa5-6391f15553f31
23872010 ML tranexamic acid 100 MG/ML InjectionSCD0277db2d-7c81-4cd0-ac19-fa12b57214281
23872010 ML tranexamic acid 100 MG/ML InjectionSCDb28a18a4-391d-48ab-8fa5-6391f15553f31
238720tranexamic acid 1000 MG per 10 ML InjectionSY0277db2d-7c81-4cd0-ac19-fa12b57214281
238720tranexamic acid 1000 MG per 10 ML InjectionSYb28a18a4-391d-48ab-8fa5-6391f15553f31

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
25021-415-102502104151010 VIAL in 1 CARTON (25021-415-10) / 10 mL in 1 VIAL10 vial2023-07-15NoNoHistorical
25021-415-662502104156610 VIAL in 1 CARTON (25021-415-66) / 10 mL in 1 VIAL10 vial2025-10-15NoNoHistorical