What is NDC 0591-2512?

0591-2512 is the product NDC for bosentan, Bosentan 125 mg/1 tablet, film coated, listed with the FDA by Actavis Pharma, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

Actavis Pharma, Inc., NDC labeler code 0591. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for bosentan?

10 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

bosentan NDC 0591-2512 | National Drug Code

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	0059125126000591251260	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.NDC labeler code 0591
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 207110
Marketing start: Jun 19, 2019
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 0591-2512_b40e9d96-1700-4b99-bd19-29d53706231cSPL ID b40e9d96-1700-4b99-bd19-29d53706231cSPL set ID 39b2a85f-4322-42d4-b420-1b1d52569143UNII 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 1, 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)

About NDC 0591-2512

What is NDC 0591-2512?: 0591-2512 is the product NDC for bosentan, Bosentan 125 mg/1 tablet, film coated, listed with the FDA by Actavis Pharma, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: bosentan.
What is the active ingredient?: Bosentan.
Who is the labeler?: Actavis Pharma, Inc., NDC labeler code 0591. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for bosentan?: 10 other product NDCs are listed under this name. See all bosentan NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other bosentan NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
bosentan	Bosentan 32 mg/1	Tablet, For suspensionOral	Zydus Pharmaceuticals USA Inc.	70710-1508	70710-1508-08
bosentan	Bosentan 32 mg/1	Tablet, For suspensionOral	Zydus Lifesciences Limited	70771-1908	70771-1908-08
Bosentan	Bosentan 32 mg/1	Tablet, For suspensionOral	Lupin Pharmaceuticals, Inc.	68180-340	68180-0340-13
bosentan	Bosentan 62.5 mg/1	Tablet, Film coatedOral	Actavis Pharma, Inc.	0591-2511	00591-2511-60
Bosentan	Bosentan 62.5 mg/1	Tablet, CoatedOral	Zydus Pharmaceuticals USA Inc.	68382-446	68382-0446-0168382-0446-0568382-0446-14+2 more
Bosentan	Bosentan 125 mg/1	Tablet, CoatedOral	Zydus Pharmaceuticals USA Inc.	68382-447	68382-0447-0168382-0447-0568382-0447-14+2 more
Bosentan	Bosentan 62.5 mg/1	TabletOral	Zydus Lifesciences Limited	70771-1017	70771-1017-0170771-1017-0470771-1017-05+2 more
Bosentan	Bosentan 125 mg/1	TabletOral	Zydus Lifesciences Limited	70771-1018	70771-1018-0170771-1018-0470771-1018-05+2 more
Bosentan	Bosentan 62.5 mg/1	Tablet, Film coatedOral	Sun Pharmaceutical Industries, Inc.	47335-038	47335-0038-6447335-0038-86
Bosentan	Bosentan 125 mg/1	Tablet, Film coatedOral	Sun Pharmaceutical Industries, Inc.	47335-039	47335-0039-6447335-0039-86

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