Home NDC 66215-101 Tracleer
Product NDC 66215-101
11-digit product format 662150101
Labeler code 66215
Product ID 66215-101_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 62.5 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 Ingredient Strength BOSENTAN 62.5 mg/1
Harmonized Identifiers# Field, Values table Field Values Unii Q326023R30 Rxcui 349253, 352066, 656659, 656660, 1989081, 1989085
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 66215-101-03 Tracleer 10 in 1 CARTON TABLET, FILM COATED 10 36 66215-101-03 Tracleer 3 in 1 BLISTER PACK TABLET, FILM COATED 3 36 66215-101-06 Tracleer 60 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 60 36 66215-101-06 Tracleer 1 in 1 CARTON TABLET, FILM COATED 1 36
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded bosentan ACTIVE INGREDIENT Q326023R30 TRACLEER (BOSENTAN) TABLET, FILM COATED [ACTELION PHARMACEUTICALS US, INC.] 10 bosentan anhydrous ACTIVE MOIETY XUL93R30K2 TRACLEER (BOSENTAN) TABLET, FILM COATED [ACTELION PHARMACEUTICALS US, INC.] 10 ethylcelluloses INACTIVE INGREDIENT 7Z8S9VYZ4B TRACLEER (BOSENTAN) TABLET, FILM COATED [ACTELION PHARMACEUTICALS US, INC.] 10 ferric oxide red INACTIVE INGREDIENT 1K09F3G675 TRACLEER (BOSENTAN) TABLET, FILM COATED [ACTELION PHARMACEUTICALS US, INC.] 10 ferric oxide yellow INACTIVE INGREDIENT EX438O2MRT TRACLEER (BOSENTAN) TABLET, FILM COATED [ACTELION PHARMACEUTICALS US, INC.] 10 glyceryl dibehenate INACTIVE INGREDIENT R8WTH25YS2 TRACLEER (BOSENTAN) TABLET, FILM COATED [ACTELION PHARMACEUTICALS US, INC.] 10 hypromelloses INACTIVE INGREDIENT 3NXW29V3WO TRACLEER (BOSENTAN) TABLET, FILM COATED [ACTELION PHARMACEUTICALS US, INC.] 10 magnesium stearate INACTIVE INGREDIENT 70097M6I30 TRACLEER (BOSENTAN) TABLET, FILM COATED [ACTELION PHARMACEUTICALS US, INC.] 10 povidone k90 INACTIVE INGREDIENT RDH86HJV5Z TRACLEER (BOSENTAN) TABLET, FILM COATED [ACTELION PHARMACEUTICALS US, INC.] 10 sodium starch glycolate type a potato INACTIVE INGREDIENT 5856J3G2A2 TRACLEER (BOSENTAN) TABLET, FILM COATED [ACTELION PHARMACEUTICALS US, INC.] 10 starch, corn INACTIVE INGREDIENT O8232NY3SJ TRACLEER (BOSENTAN) TABLET, FILM COATED [ACTELION PHARMACEUTICALS US, INC.] 10 talc INACTIVE INGREDIENT 7SEV7J4R1U TRACLEER (BOSENTAN) TABLET, FILM COATED [ACTELION PHARMACEUTICALS US, INC.] 10 titanium dioxide INACTIVE INGREDIENT 15FIX9V2JP TRACLEER (BOSENTAN) TABLET, FILM COATED [ACTELION PHARMACEUTICALS US, INC.] 10 triacetin INACTIVE INGREDIENT XHX3C3X673 TRACLEER (BOSENTAN) TABLET, FILM COATED [ACTELION PHARMACEUTICALS US, INC.] 10
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 66215-101 TRACLEER (BOSENTAN) TABLET, FILM COATED TRACLEER (BOSENTAN) TABLET, FOR SUSPENSION [ACTELION PHARMACEUTICALS US, INC.] 32 Current NDC, Legacy NDC, 4 package rows 20240223_749e42fb-2fe0-45dd-9268-b43bb3f4081c.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 66215-101-03 66215010103 10 BLISTER PACK in 1 CARTON (66215-101-03) / 3 TABLET, FILM COATED in 1 BLISTER PACK 10 blister pack 2012-10-02 0000-00-00 No No Current 66215-101-06 66215010106 1 BOTTLE, PLASTIC in 1 CARTON (66215-101-06) / 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC 2001-11-20 0000-00-00 No No Current