NDC codes

FDA NDC Directory
Product NDC (as listed)59651-147Labeler and product segments. Claims need a package NDC.
Product NDC at billing width59651-0147Add 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 NDC11-digit (billing)PackageCopy
59651-147-30596510147305965101473030 TABLET, FILM COATED in 1 BOTTLE (59651-147-30)Marketed from Jun 8, 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
Aurobindo Pharma LimitedNDC labeler code 59651
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 211198
Marketing start
Listing expires
Other FDA classes
Endothelin Receptor Antagonists (Mechanism)
Identifiers
Product ID 59651-147_42ab2500-6348-49c2-9d29-074933ef2f9eSPL ID 42ab2500-6348-49c2-9d29-074933ef2f9eSPL set ID 88b9f3b0-3f8f-47e4-bbd7-a2a785ed4ac0RxCUI 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

N459651014730 followed by a unit qualifier and the quantity

Package 59651-0147-30. 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 . This label includes a boxed warning.

Indications (excerpt from the label)

Macitentan is 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 is 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 (57%), PAH caused…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 59651-147

What is NDC 59651-147?
59651-147 is the product NDC for Macitentan, Macitentan 10 mg/1 tablet, film coated, listed with the FDA by Aurobindo Pharma Limited. It has 1 package NDC, 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?
Aurobindo Pharma Limited, NDC labeler code 59651. 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
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
MacitentanMacitentan 10 mg/1Tablet, Film coatedOralANI Pharmaceuticals, Inc.70954-02570954-0025-1070954-0025-20
macitentanMacitentan 10 mg/1Tablet, Film coatedOralApotex Corp.60505-464460505-4644-03
MacitentanMacitentan 10 mg/1Tablet, Film coatedOralMylan Pharmaceuticals Inc.0378-060600378-0606-93
macitentanMacitentan 10 mg/1Tablet, Film coatedOralTeva Pharmaceuticals, Inc.0480-091500480-0915-56
MacitentanMacitentan 10 mg/1Tablet, Film coatedOralAmneal Pharmaceuticals NY LLC69238-132769238-1327-03
MacitentanMacitentan 10 mg/1Tablet, Film coatedOralAlembic Pharmaceuticals Limited46708-37346708-0373-30
MacitentanMacitentan 10 mg/1Tablet, Film coatedOralSun Pharmaceutical Industries, Inc.47335-07047335-0070-1547335-0070-30
MacitentanMacitentan 10 mg/1Tablet, Film coatedOralAlembic Pharmaceuticals Inc.62332-37362332-0373-30
MacitentanMacitentan 10 mg/1TabletOralTorrent Pharmaceuticals Limited13668-54213668-0542-0513668-0542-3013668-0542-90
MacitentanMacitentan 10 mg/1Tablet, Film coatedOralLaurus Labs Limited42385-90742385-0907-1542385-0907-30

All 14 Macitentan NDCs

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