Prescription drug · ANDA
Ambrisentan NDC 51407-594
Ambrisentan 5 mg/1 · Tablet, Film coated · Oral · Golden State Medical Supply, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 51407-594-30 | 51407059430 | 30 TABLET, FILM COATED in 1 BOTTLE (51407-594-30)Marketed from Nov 17, 2025 |
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)
- Ambrisentan
- Generic name (nonproprietary)
- ambrisentan
- Active ingredients
- Ambrisentan — 5 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 210701
- Marketing start
- Listing expires
- Other FDA classes
- Endothelin Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 51407-594_496834ab-a472-147d-e063-6394a90a12f3SPL ID 496834ab-a472-147d-e063-6394a90a12f3SPL set ID 4396bab5-2851-62ef-e063-6294a90af76eRxCUI 722116, 722122UNII HW6NV07QEC
- 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
N451407059430followed by a unit qualifier and the quantityPackage 51407-0594-30. 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)
Ambrisentan tablets are indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) in adult patients: To improve exercise ability and delay clinical worsening. Studies establishing effectiveness included predominantly patients with WHO Functional Class II–III symptoms and etiologies of idiopathic or heritable PAH (60%) or PAH associated with connective tissue diseases (34%). Ambrisentan tablets are an endothelin receptor antagonist indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) in adult patients: To improve exercise ability and delay clinical worsening. Studies establishing effectiveness included trials predominantly in patients wit…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 210701
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 |
|---|---|---|---|---|
| Ambrisentan | Ambrisentan 10 mg/1 | Tablet, Film coatedOral | Golden State Medical Supply, Inc. | 51407-595 |
| Ambrisentan | Ambrisentan 5 mg/1 | Tablet, Film coatedOral | Apotex Corp. | 60505-4552 |
| Ambrisentan | Ambrisentan 10 mg/1 | Tablet, Film coatedOral | Apotex Corp. | 60505-4553 |