Tracleer
- Product NDC
- 66215-103
- 11-digit product format
- 662150103
- Labeler code
- 66215
- Product ID
- 66215-103_c5b01aea-c7d8-45d7-8f5f-5fd8733d7085
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- bosentan
- Dosage form
- TABLET, SOLUBLE
- Route
- ORAL
- Labeler
- Actelion Pharmaceuticals US, Inc.
- Application
- NDA209279
- Marketing category
- NDA
- Marketing start
- 2017-11-13
- Marketing end
- 0000-00-00
- Substance
- BOSENTAN
- Active strength
- 32 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
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
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 |
|---|
| 66215-103 | TRACLEER (BOSENTAN) TABLET, FILM COATED TRACLEER (BOSENTAN) TABLET, FOR SUSPENSION [ACTELION PHARMACEUTICALS US, INC.] | 32 | Legacy NDC | 20240223_749e42fb-2fe0-45dd-9268-b43bb3f4081c.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 66215-103-56 | 66215010356 | 4 BLISTER PACK in 1 CARTON (66215-103-56) > 14 TABLET, SOLUBLE in 1 BLISTER PACK (66215-103-14) | 4 blister pack | 2017-11-13 | 0000-00-00 | No | No | Current |