Prescription drug · ANDA
Macitentan NDC 47335-070
Macitentan 10 mg/1 · Tablet, Film coated · Oral · Sun Pharmaceutical Industries, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 47335-070-15 | 47335007015 | 5 BLISTER PACK in 1 CARTON (47335-070-15) / 3 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Jun 6, 2026 | |
| 47335-070-30 | 47335007030 | 1 BOTTLE in 1 CARTON (47335-070-30) / 30 TABLET, FILM COATED in 1 BOTTLEMarketed from Jun 6, 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
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 211123
- Marketing start
- Listing expires
- Other FDA classes
- Endothelin Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 47335-070_51103591-8124-ac72-e063-6394a90a932bSPL ID 51103591-8124-ac72-e063-6394a90a932bSPL set ID 8de5c74f-b172-4485-a3f0-95e0172299d8RxCUI 1442137UNII Z9K9Y9WMVLUPC 0347335070309
- 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
N447335007015followed by a unit qualifier and the quantityPackage 47335-0070-15. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
Macitentan tablets are 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-III symptoms treated for an average of 2 years. Patients had idiopathic and heritable PAH (57%), …
Excerpt only. Read the full label for complete information.