Prescription drug · ANDA
Macitentan NDC 59651-147
Macitentan 10 mg/1 · Tablet, Film coated · Oral · Aurobindo Pharma Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 59651-147-30 | 5965101473059651014730 | 30 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
N459651014730followed by a unit qualifier and the quantityPackage 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.
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.
Related NDCs: other Macitentan products
Other finished products listed under the same name: strengths, forms and labelers.
| 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 | 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 |
| Macitentan | Macitentan 10 mg/1 | Tablet, Film coatedOral | Laurus Labs Limited | 42385-907 | 42385-0907-1542385-0907-30 |