Bosentan NDC 68382-447

NDC codes

FDA NDC Directory

Product NDC (as listed)68382-447Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68382-0447Add 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
68382-447-01	68382044701	100 TABLET, COATED in 1 BOTTLE (68382-447-01)Marketed from May 1, 2019
68382-447-05	68382044705	500 TABLET, COATED in 1 BOTTLE (68382-447-05)Marketed from May 1, 2019
68382-447-14	68382044714	60 TABLET, COATED in 1 BOTTLE (68382-447-14)Marketed from May 1, 2019
68382-447-28	68382044728	180 TABLET, COATED in 1 BOTTLE (68382-447-28)Marketed from May 1, 2019
68382-447-77	68382044777	10 BLISTER PACK in 1 CARTON (68382-447-77) / 10 TABLET, COATED in 1 BLISTER PACK (68382-447-30)Marketed from May 1, 2019

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): Bosentan
Generic name (nonproprietary): bosentan
Active ingredients: Bosentan — 125 mg/1
Dosage form: Tablet, Coated
Route: Oral
Labeler: Zydus Pharmaceuticals USA Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 207760
Marketing start: May 1, 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 68382-447_6f108d08-40d2-4db6-a938-f6c3b54b3e02SPL ID 6f108d08-40d2-4db6-a938-f6c3b54b3e02SPL set ID 8444da17-6c31-492b-8842-93740f083d9dRxCUI 349253, 656659UNII 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

N468382044701 followed by a unit qualifier and the quantity

Package 68382-0447-01. 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 Jun 2, 2026. 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 abilit…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 207760

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

FDA NDC Directory listings under ANDA 207760
Product	Strength	Form · route	Labeler	Product NDC
Bosentan	Bosentan 62.5 mg/1	TabletOral	Zydus Lifesciences Limited	70771-1017
Bosentan	Bosentan 125 mg/1	TabletOral	Zydus Lifesciences Limited	70771-1018
Bosentan	Bosentan 62.5 mg/1	Tablet, CoatedOral	Zydus Pharmaceuticals USA Inc.	68382-446