Tracleer (bosentan) NDC 66215-101

NDC codes

FDA NDC Directory

Product NDC (as listed)66215-101Labeler and product segments. Claims need a package NDC.

Product NDC at billing width66215-0101Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
66215-101-03	66215010103	10 BLISTER PACK in 1 CARTON (66215-101-03) / 3 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Oct 2, 2012
66215-101-06	66215010106	1 BOTTLE, PLASTIC in 1 CARTON (66215-101-06) / 60 TABLET, FILM COATED in 1 BOTTLE, PLASTICMarketed from Nov 20, 2001

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary): Tracleer
Generic name (nonproprietary): bosentan
Active ingredients: Bosentan — 62.5 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Actelion Pharmaceuticals US, Inc.
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 021290
Marketing start: Nov 20, 2001
Listing expires: Dec 31, 2027
Other FDA classes: Cytochrome P450 2C9 Inducers (Mechanism)Cytochrome P450 3A Inducers (Mechanism)Endothelin Receptor Antagonists (Mechanism)
Identifiers: Product ID 66215-101_f52a8c9c-529d-4bd8-9bfb-d91161935c20SPL ID f52a8c9c-529d-4bd8-9bfb-d91161935c20SPL set ID 749e42fb-2fe0-45dd-9268-b43bb3f4081cRxCUI 349253, 352066, 656659, 656660, 1989081, 1989085UNII Q326023R30
Pharmacologic class: Endothelin Receptor Antagonist

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N466215010103 followed by a unit qualifier and the quantity

Package 66215-0101-03. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective Nov 17, 2025. This label includes a boxed warning.

Indications (excerpt from the label)

TRACLEER is indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1): in adults to improve exercise ability and to decrease clinical worsening. Studies establishing effectiveness included predominantly patients with WHO Functional Class II-IV symptoms and etiologies of idiopathic or heritable PAH (60%), PAH associated with connective tissue diseases (21%), and PAH associated with congenital heart disease with left-to-right shunts (18%) [see Clinical Studies (14.1) ] . in pediatric patients aged 3 years and older with idiopathic or congenital PAH to improve pulmonary vascular resistance (PVR), which is expected to result in an improvement in exercise ability. TRACLEE…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 021290

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under NDA 021290
Product	Strength	Form · route	Labeler	Product NDC
Tracleerbosentan	Bosentan 125 mg/1	Tablet, Film coatedOral	Actelion Pharmaceuticals US, Inc.	66215-102