FDA.reportPublic FDA data

Tranexamic Acid

Product NDC
0591-3720
11-digit product format
005913720
Labeler code
0591
Product ID
0591-3720_b97d11de-dcc7-4b90-8f6a-c46848eddab3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tranexamic Acid
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Actavis Pharma, Inc.
Application
ANDA202093
Marketing category
ANDA
Marketing start
2013-01-03
Substance
TRANEXAMIC ACID
Active strength
650 mg/1
Pharmacologic classes
Antifibrinolytic Agent [EPC], Decreased Fibrinolysis [PE]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Tranexamic Acid
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TRANEXAMIC ACID650 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6T84R30KC1
Rxcui883826

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
8234c772-5c41-424c-a33e-e06e8c4de9c1Product name220250626
fbe2ea47-480e-f5f1-0d64-c87fd5ac923bProduct name420250224
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
510b43a3-8143-a25f-19c6-476c90dbb618Product name920171115

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0591-3720-10Tranexamic Acid1000 in 1 BOTTLE, PLASTICTABLET, FILM COATED100018
0591-3720-30Tranexamic Acid30 in 1 BOTTLE, PLASTICTABLET, FILM COATED3018

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0591-3720-30EA - Each0591-3720719d89b5-060d-4192-a256-83d7b4c8175112013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TRANEXAMIC ACIDACTIVE INGREDIENT6T84R30KC1TRANEXAMIC ACID TABLET, FILM COATED [ACTAVIS PHARMA, INC.]10
TRANEXAMIC ACIDACTIVE MOIETY6T84R30KC1TRANEXAMIC ACID TABLET, FILM COATED [ACTAVIS PHARMA, INC.]10
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTRANEXAMIC ACID TABLET, FILM COATED [ACTAVIS PHARMA, INC.]10
COPOVIDONE K25-31INACTIVE INGREDIENTD9C330MD8BTRANEXAMIC ACID TABLET, FILM COATED [ACTAVIS PHARMA, INC.]10
CROSPOVIDONEINACTIVE INGREDIENT68401960MKTRANEXAMIC ACID TABLET, FILM COATED [ACTAVIS PHARMA, INC.]10
DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMERINACTIVE INGREDIENT905HNO1SIHTRANEXAMIC ACID TABLET, FILM COATED [ACTAVIS PHARMA, INC.]10
GLYCERYL DIBEHENATEINACTIVE INGREDIENTR8WTH25YS2TRANEXAMIC ACID TABLET, FILM COATED [ACTAVIS PHARMA, INC.]10
HYPROMELLOSE 2910 (5 MPA.S)INACTIVE INGREDIENTR75537T0T4TRANEXAMIC ACID TABLET, FILM COATED [ACTAVIS PHARMA, INC.]10
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOTRANEXAMIC ACID TABLET, FILM COATED [ACTAVIS PHARMA, INC.]10
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XTRANEXAMIC ACID TABLET, FILM COATED [ACTAVIS PHARMA, INC.]10
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TRANEXAMIC ACID TABLET, FILM COATED [ACTAVIS PHARMA, INC.]10
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ATRANEXAMIC ACID TABLET, FILM COATED [ACTAVIS PHARMA, INC.]10
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4TRANEXAMIC ACID TABLET, FILM COATED [ACTAVIS PHARMA, INC.]10
TALCINACTIVE INGREDIENT7SEV7J4R1UTRANEXAMIC ACID TABLET, FILM COATED [ACTAVIS PHARMA, INC.]10
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMTRANEXAMIC ACID TABLET, FILM COATED [ACTAVIS PHARMA, INC.]10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0591-3720TRANEXAMIC ACID TABLET, FILM COATED [ACTAVIS PHARMA, INC.]16Current NDC, Legacy NDC, 2 package rows20210204_3f07e93b-3568-487e-894f-8f90e5a0960a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
883826tranexamic acid 650 MG Oral TabletPSN128c39ce-f625-47ec-9efe-4de696e5220f103
883826tranexamic acid 650 MG Oral TabletSCD128c39ce-f625-47ec-9efe-4de696e5220f103
883826tranexamic acid 650 MG Oral TabletPSN4ddba10f-705a-40af-83b8-aa1fd68891f8101
883826tranexamic acid 650 MG Oral TabletSCD4ddba10f-705a-40af-83b8-aa1fd68891f8101
883826tranexamic acid 650 MG Oral TabletPSN3f07e93b-3568-487e-894f-8f90e5a0960a18
883826tranexamic acid 650 MG Oral TabletSCD3f07e93b-3568-487e-894f-8f90e5a0960a18

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0591-3720-10005913720101000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0591-3720-10) 2013-01-030000-00-00NoNoCurrent
0591-3720-300059137203030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0591-3720-30) 2013-01-030000-00-00NoNoCurrent