FDA.reportPublic FDA data

Tracleer

Product NDC
66215-102
11-digit product format
662150102
Labeler code
66215
Product ID
66215-102_f52a8c9c-529d-4bd8-9bfb-d91161935c20
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
bosentan
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Actelion Pharmaceuticals US, Inc.
Application
NDA021290
Marketing category
NDA
Marketing start
2001-11-20
Substance
BOSENTAN
Active strength
125 mg/1
Pharmacologic classes
Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 3A Inducers [MoA], Endothelin Receptor Antagonist [EPC], Endothelin Receptor Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BOSENTAN125 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiQ326023R30
Rxcui349253, 352066, 656659, 656660, 1989081, 1989085

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d212b88c-a939-e294-be87-fb95301c9fbbProduct name620251118
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66215-102-03Tracleer3 in 1 BLISTER PACKTABLET, FILM COATED336
66215-102-03Tracleer10 in 1 CARTONTABLET, FILM COATED1036
66215-102-06Tracleer1 in 1 CARTONTABLET, FILM COATED136
66215-102-06Tracleer60 in 1 BOTTLE, PLASTICTABLET, FILM COATED6036

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
66215-102-03EA - Each66215-1021bd0bdf2-1d76-4f8a-a2d7-51ccb82136bb12013-02-13
66215-102-06EA - Each66215-1024d0e855f-508a-4c50-9912-45e56c0cfe1112012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
bosentanACTIVE INGREDIENTQ326023R30TRACLEER (BOSENTAN) TABLET, FILM COATED [ACTELION PHARMACEUTICALS US, INC.]10
bosentan anhydrousACTIVE MOIETYXUL93R30K2TRACLEER (BOSENTAN) TABLET, FILM COATED [ACTELION PHARMACEUTICALS US, INC.]10
ethylcellulosesINACTIVE INGREDIENT7Z8S9VYZ4BTRACLEER (BOSENTAN) TABLET, FILM COATED [ACTELION PHARMACEUTICALS US, INC.]10
ferric oxide redINACTIVE INGREDIENT1K09F3G675TRACLEER (BOSENTAN) TABLET, FILM COATED [ACTELION PHARMACEUTICALS US, INC.]10
ferric oxide yellowINACTIVE INGREDIENTEX438O2MRTTRACLEER (BOSENTAN) TABLET, FILM COATED [ACTELION PHARMACEUTICALS US, INC.]10
glyceryl dibehenateINACTIVE INGREDIENTR8WTH25YS2TRACLEER (BOSENTAN) TABLET, FILM COATED [ACTELION PHARMACEUTICALS US, INC.]10
hypromellosesINACTIVE INGREDIENT3NXW29V3WOTRACLEER (BOSENTAN) TABLET, FILM COATED [ACTELION PHARMACEUTICALS US, INC.]10
magnesium stearateINACTIVE INGREDIENT70097M6I30TRACLEER (BOSENTAN) TABLET, FILM COATED [ACTELION PHARMACEUTICALS US, INC.]10
povidone k90INACTIVE INGREDIENTRDH86HJV5ZTRACLEER (BOSENTAN) TABLET, FILM COATED [ACTELION PHARMACEUTICALS US, INC.]10
sodium starch glycolate type a potatoINACTIVE INGREDIENT5856J3G2A2TRACLEER (BOSENTAN) TABLET, FILM COATED [ACTELION PHARMACEUTICALS US, INC.]10
starch, cornINACTIVE INGREDIENTO8232NY3SJTRACLEER (BOSENTAN) TABLET, FILM COATED [ACTELION PHARMACEUTICALS US, INC.]10
talcINACTIVE INGREDIENT7SEV7J4R1UTRACLEER (BOSENTAN) TABLET, FILM COATED [ACTELION PHARMACEUTICALS US, INC.]10
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPTRACLEER (BOSENTAN) TABLET, FILM COATED [ACTELION PHARMACEUTICALS US, INC.]10
triacetinINACTIVE INGREDIENTXHX3C3X673TRACLEER (BOSENTAN) TABLET, FILM COATED [ACTELION PHARMACEUTICALS US, INC.]10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66215-102TRACLEER (BOSENTAN) TABLET, FILM COATED TRACLEER (BOSENTAN) TABLET, FOR SUSPENSION [ACTELION PHARMACEUTICALS US, INC.]32Current NDC, Legacy NDC, 4 package rows20240223_749e42fb-2fe0-45dd-9268-b43bb3f4081c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
656659bosentan 125 MG Oral TabletPSN749e42fb-2fe0-45dd-9268-b43bb3f4081c36
1989081bosentan 32 MG Tablet for Oral SuspensionPSN749e42fb-2fe0-45dd-9268-b43bb3f4081c36
349253bosentan 62.5 MG Oral TabletPSN749e42fb-2fe0-45dd-9268-b43bb3f4081c36
656660Tracleer 125 MG Oral TabletPSN749e42fb-2fe0-45dd-9268-b43bb3f4081c36
1989085Tracleer 32 MG Tablet for Oral SuspensionPSN749e42fb-2fe0-45dd-9268-b43bb3f4081c36
352066Tracleer 62.5 MG Oral TabletPSN749e42fb-2fe0-45dd-9268-b43bb3f4081c36
656660bosentan 125 MG Oral Tablet [Tracleer]SBD749e42fb-2fe0-45dd-9268-b43bb3f4081c36
1989085bosentan 32 MG Tablet for Oral Suspension [Tracleer]SBD749e42fb-2fe0-45dd-9268-b43bb3f4081c36
352066bosentan 62.5 MG Oral Tablet [Tracleer]SBD749e42fb-2fe0-45dd-9268-b43bb3f4081c36
656659bosentan 125 MG Oral TabletSCD749e42fb-2fe0-45dd-9268-b43bb3f4081c36
1989081bosentan 32 MG Tablet for Oral SuspensionSCD749e42fb-2fe0-45dd-9268-b43bb3f4081c36
349253bosentan 62.5 MG Oral TabletSCD749e42fb-2fe0-45dd-9268-b43bb3f4081c36
656659bosentan (as bosentan hydrochloride) 125 MG Oral TabletSY749e42fb-2fe0-45dd-9268-b43bb3f4081c36
349253bosentan (as bosentan hydrochloride) 62.5 MG Oral TabletSY749e42fb-2fe0-45dd-9268-b43bb3f4081c36
656660Tracleer 125 MG Oral TabletSY749e42fb-2fe0-45dd-9268-b43bb3f4081c36
1989085Tracleer 32 MG Tablet for Oral SuspensionSY749e42fb-2fe0-45dd-9268-b43bb3f4081c36
352066Tracleer 62.5 MG Oral TabletSY749e42fb-2fe0-45dd-9268-b43bb3f4081c36

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
66215-102-036621501020310 BLISTER PACK in 1 CARTON (66215-102-03) / 3 TABLET, FILM COATED in 1 BLISTER PACK10 blister pack2012-10-020000-00-00NoNoCurrent
66215-102-06662150102061 BOTTLE, PLASTIC in 1 CARTON (66215-102-06) / 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC2001-11-200000-00-00NoNoCurrent