Prescription drug · ANDA
Macitentan NDC 62332-373
Macitentan 10 mg/1 · Tablet, Film coated · Oral · Alembic Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 62332-373-30 | 62332037330 | 30 TABLET, FILM COATED in 1 BOTTLE (62332-373-30)Marketed 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
- Labeler
- Alembic Pharmaceuticals Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 211128
- Marketing start
- Listing expires
- Other FDA classes
- Endothelin Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 62332-373_474cbf43-5f14-4bbb-b3c9-0cbc575fd506SPL ID 474cbf43-5f14-4bbb-b3c9-0cbc575fd506SPL set ID 98b3309a-5012-42b5-b773-a38c2f52296cRxCUI 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
N462332037330followed by a unit qualifier and the quantityPackage 62332-0373-30. 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
Label details couldn’t be retrieved right now. Open the label on DailyMed.
Other NDCs under ANDA 211128
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Macitentan | Macitentan 10 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Limited | 46708-373 |