What is NDC 42385-907?

42385-907 is the product NDC for Macitentan, Macitentan 10 mg/1 tablet, film coated, listed with the FDA by Laurus Labs Limited. It has 2 package NDCs, shown above in 10- and 11-digit form.

Laurus Labs Limited, NDC labeler code 42385. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Macitentan?

13 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Macitentan NDC 42385-907 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)42385-907Labeler and product segments. Claims need a package NDC.

Product NDC at billing width42385-0907Add 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
42385-907-15	4238509071542385090715	1 BLISTER PACK in 1 CARTON (42385-907-15) / 15 TABLET, FILM COATED in 1 BLISTER PACKMarketed from May 15, 2026
42385-907-30	4238509073042385090730	30 TABLET, FILM COATED in 1 BOTTLE (42385-907-30)Marketed from May 15, 2026

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): Macitentan
Generic name (nonproprietary): macitentan
Active ingredients: Macitentan — 10 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Laurus Labs LimitedNDC labeler code 42385
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 211120
Marketing start: May 15, 2026
Listing expires: Dec 31, 2026
Other FDA classes: Endothelin Receptor Antagonists (Mechanism)
Identifiers: Product ID 42385-907_93f0ab4a-4756-4915-a000-ed65b26cd61cSPL ID 93f0ab4a-4756-4915-a000-ed65b26cd61cSPL set ID 93f0ab4a-4756-4915-a000-ed65b26cd61cRxCUI 1442137UNII Z9K9Y9WMVL
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

N442385090715 followed by a unit qualifier and the quantity

Package 42385-0907-15. 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 10, 2025. This label includes a boxed warning.

Indications (excerpt from the label)

Macitentan tablets are an endothelin receptor antagonist (ERA) indicated for the treatment of pulmonary arterial hypertension (PAH, WHO Group I) in adults to reduce the risks of disease progression and hospitalization for PAH ( 1.1 ). 1.1 Pulmonary Arterial Hypertension Macitentan tablets are an endothelin receptor antagonist (ERA) indicated for the treatment of pulmonary arterial hypertension (PAH, WHO Group I) in adults to reduce the risks of disease progression and hospitalization for PAH. Effectiveness was established in a long-term study in PAH patients with predominantly WHO Functional Class II to III symptoms treated for an average of 2 years. Patients had idiopathic and heritable PAH…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 42385-907

What is NDC 42385-907?: 42385-907 is the product NDC for Macitentan, Macitentan 10 mg/1 tablet, film coated, listed with the FDA by Laurus Labs Limited. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Macitentan.
What is the active ingredient?: Macitentan.
Who is the labeler?: Laurus Labs Limited, NDC labeler code 42385. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Macitentan?: 13 other product NDCs are listed under this name. See all Macitentan 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 Macitentan NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Macitentan	Macitentan 10 mg/1	Tablet, Film coatedOral	ANI Pharmaceuticals, Inc.	70954-025	70954-0025-1070954-0025-20
macitentan	Macitentan 10 mg/1	Tablet, Film coatedOral	Apotex Corp.	60505-4644	60505-4644-03
Macitentan	Macitentan 10 mg/1	Tablet, Film coatedOral	Mylan Pharmaceuticals Inc.	0378-0606	00378-0606-93
macitentan	Macitentan 10 mg/1	Tablet, Film coatedOral	Teva Pharmaceuticals, Inc.	0480-0915	00480-0915-56
Macitentan	Macitentan 10 mg/1	Tablet, Film coatedOral	Aurobindo Pharma Limited	59651-147	59651-0147-30
Macitentan	Macitentan 10 mg/1	Tablet, Film coatedOral	Amneal Pharmaceuticals NY LLC	69238-1327	69238-1327-03
Macitentan	Macitentan 10 mg/1	Tablet, Film coatedOral	Alembic Pharmaceuticals Limited	46708-373	46708-0373-30
Macitentan	Macitentan 10 mg/1	Tablet, Film coatedOral	Sun Pharmaceutical Industries, Inc.	47335-070	47335-0070-1547335-0070-30
Macitentan	Macitentan 10 mg/1	Tablet, Film coatedOral	Alembic Pharmaceuticals Inc.	62332-373	62332-0373-30
Macitentan	Macitentan 10 mg/1	TabletOral	Torrent Pharmaceuticals Limited	13668-542	13668-0542-0513668-0542-3013668-0542-90

All 14 Macitentan NDCs

Other NDCs under ANDA 211120

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

FDA NDC Directory listings under ANDA 211120
Product	Strength	Form · route	Labeler	Product NDC
Macitentan	Macitentan 10 mg/1	Tablet, Film coatedOral	ANI Pharmaceuticals, Inc.	70954-025