bosentan NDC 0591-2512

NDC codes

FDA NDC Directory

Product NDC (as listed)0591-2512Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00591-2512Add 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
0591-2512-60	00591251260	60 TABLET, FILM COATED in 1 BOTTLE (0591-2512-60)Marketed from Jun 19, 2019

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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): bosentan
Generic name (nonproprietary): bosentan
Active ingredients: Bosentan — 125 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Actavis Pharma, Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 207110
Marketing start: Jun 19, 2019
Listing expires: Dec 31, 2026
Other FDA classes: Cytochrome P450 2C9 Inducers (Mechanism)Cytochrome P450 3A Inducers (Mechanism)Endothelin Receptor Antagonists (Mechanism)
Identifiers: Product ID 0591-2512_8f3d0f83-84b4-4860-9478-c86488f41001SPL ID 8f3d0f83-84b4-4860-9478-c86488f41001SPL set ID 39b2a85f-4322-42d4-b420-1b1d52569143RxCUI 349253, 656659UNII Q326023R30UPC 0305912512604, 0305912511607
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

N400591251260 followed by a unit qualifier and the quantity

Package 00591-2512-60. 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 30, 2025. This label includes a boxed warning.

Indications (excerpt from the label)

Bosentan tablets are 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…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 207110

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

FDA NDC Directory listings under ANDA 207110
Product	Strength	Form · route	Labeler	Product NDC
bosentan	Bosentan 62.5 mg/1	Tablet, Film coatedOral	Actavis Pharma, Inc.	0591-2511