FDA.reportPublic FDA data

Tranexamic Acid

Product NDC
60505-3638
11-digit product format
605053638
Labeler code
60505
Product ID
60505-3638_5cf85923-2ace-9ed8-8377-c7e764ca5f61
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tranexamic Acid
Dosage form
TABLET
Route
ORAL
Labeler
Apotex Corp.
Application
ANDA202286
Marketing category
ANDA
Marketing start
2014-01-27
Marketing end
2022-03-31
Substance
TRANEXAMIC ACID
Active strength
650 1/1
Pharmacologic classes
Antifibrinolytic Agent [EPC],Decreased Fibrinolysis [PE]
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct60505-3638DDiscontinued by firm2026-07-31
excluded packagepackage60505-363860505-3638-1DDiscontinued by firm2026-07-31
excluded packagepackage60505-363860505-3638-3DDiscontinued by firm2026-07-31

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A202286-001TRANEXAMIC ACIDTRANEXAMIC ACID650MGTABLET / ORAL2014-01-27

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A202286-001TRANEXAMIC ACID650MGTABLET / ORAL2014-01-27a50c72e98297…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60505-3638-1EA - Each60505-3638809ebeda-7249-4ba4-a15d-85cdfc39acb012014-04-03
60505-3638-3EA - Each60505-363883cc1f59-bdee-4a07-bd02-fbd904de9e0c12014-04-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TRANEXAMIC ACIDACTIVE INGREDIENT6T84R30KC1TRANEXAMIC ACID TABLET [APOTEX CORP.]2
TRANEXAMIC ACIDACTIVE MOIETY6T84R30KC1TRANEXAMIC ACID TABLET [APOTEX CORP.]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48TRANEXAMIC ACID TABLET [APOTEX CORP.]2
ETHYLCELLULOSESINACTIVE INGREDIENT7Z8S9VYZ4BTRANEXAMIC ACID TABLET [APOTEX CORP.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TRANEXAMIC ACID TABLET [APOTEX CORP.]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4TRANEXAMIC ACID TABLET [APOTEX CORP.]2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60505-3638-36050536380330 TABLET in 1 BOTTLE (60505-3638-3) 30 tablet2014-01-272022-03-31NoNoCurrent