FDA.reportPublic FDA data

tranexamic acid

Product NDC
81284-612
11-digit product format
812840612
Labeler code
81284
Product ID
81284-612_9319bf8d-71d6-40da-8ea6-39036da7d192
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tranexamic Acid
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Provepharm Inc.
Application
ANDA212676
Marketing category
ANDA
Marketing start
2021-09-30
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
510b43a3-8143-a25f-19c6-476c90dbb618Product name920171115

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81284-612-00tranexamic acid10 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION105
81284-612-10tranexamic acid10 in 1 CARTONINJECTION, SOLUTION105

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
81284-612-00ML - Milliliter81284-612b2a4466d-03f8-42e0-ba1e-6d17a5875a1712022-03-09
81284-612-10ML - Milliliter81284-61208e9dd4f-afad-4053-bfb4-ed670d942dcb12022-03-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81284-612TRANEXAMIC ACID INJECTION, SOLUTION [PROVEPHARM INC.]4Current NDC, Legacy NDC, 2 package rows20240312_1b8c3500-8e87-4b6e-b6a9-8da5f9c00820.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
238720tranexamic acid 1000 MG in 10 ML InjectionPSN1b8c3500-8e87-4b6e-b6a9-8da5f9c008205
23872010 ML tranexamic acid 100 MG/ML InjectionSCD1b8c3500-8e87-4b6e-b6a9-8da5f9c008205
238720tranexamic acid 1000 MG per 10 ML InjectionSY1b8c3500-8e87-4b6e-b6a9-8da5f9c008205

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
81284-612-008128406120010 mL in 1 VIAL, SINGLE-DOSE10 mlHistorical
81284-612-108128406121010 VIAL, SINGLE-DOSE in 1 CARTON (81284-612-10) / 10 mL in 1 VIAL, SINGLE-DOSE (81284-612-00) 2021-09-300000-00-00NoNoCurrent