Prescription drug · ANDA
Ambrisentan NDC 82009-141
Ambrisentan 5 mg/1 · Tablet, Film coated · Oral · Quallent Pharmaceuticals Health LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 82009-141-30 | 82009014130 | 30 TABLET, FILM COATED in 1 BOTTLE (82009-141-30)Marketed from May 1, 2024 |
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
- Labeler
- Quallent Pharmaceuticals Health LLCNDC labeler code 82009
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 210058
- Marketing start
- Listing expires
- Other FDA classes
- Endothelin Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 82009-141_64a9be1d-a83b-40aa-942f-18c6a9382dfaSPL ID 64a9be1d-a83b-40aa-942f-18c6a9382dfaSPL set ID 6fc6032f-94dc-4067-8b24-01990ec99db0RxCUI 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
N482009014130followed by a unit qualifier and the quantityPackage 82009-0141-30. 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 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 with W…
Excerpt only. Read the full label for complete information.
About NDC 82009-141
- What is NDC 82009-141?
- 82009-141 is the product NDC for Ambrisentan, Ambrisentan 5 mg/1 tablet, film coated, listed with the FDA by Quallent Pharmaceuticals Health LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Ambrisentan.
- What is the active ingredient?
- Ambrisentan.
- Who is the labeler?
- Quallent Pharmaceuticals Health LLC, NDC labeler code 82009. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Ambrisentan?
- 23 other product NDCs are listed under this name. See all Ambrisentan NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Ambrisentan products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Ambrisentan | Ambrisentan 10 mg/1 | Tablet, Film coatedOral | Quallent Pharmaceuticals Health LLC | 82009-142 | 82009-0142-30 |
| Ambrisentan | Ambrisentan 5 mg/1 | Tablet, Film coatedOral | Apotex Corp. | 60505-4552 | 60505-4552-03 |
| Ambrisentan | Ambrisentan 10 mg/1 | Tablet, Film coatedOral | Apotex Corp. | 60505-4553 | 60505-4553-03 |
| ambrisentan | Ambrisentan 10 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-7670 | 50090-7670-00 |
| ambrisentan | Ambrisentan 5 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-7671 | 50090-7671-00 |
| ambrisentan | Ambrisentan 5 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 59651-494 | 59651-0494-30 |
| ambrisentan | Ambrisentan 10 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 59651-495 | 59651-0495-30 |
| Ambrisentan | Ambrisentan 5 mg/1 | Tablet, Film coatedOral | Golden State Medical Supply, Inc. | 51407-594 | 51407-0594-30 |
| Ambrisentan | Ambrisentan 10 mg/1 | Tablet, Film coatedOral | Golden State Medical Supply, Inc. | 51407-595 | 51407-0595-30 |
| Ambrisentan | Ambrisentan 5 mg/1 | Tablet, Film coatedOral | Actavis Pharma, Inc. | 0591-2405 | 00591-2405-30 |
Other NDCs under ANDA 210058
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 5 mg/1 | Tablet, Film coatedOral | Zydus Pharmaceuticals USA Inc. | 70710-1179 |
| Ambrisentan | Ambrisentan 10 mg/1 | Tablet, Film coatedOral | Zydus Pharmaceuticals USA Inc. | 70710-1180 |
| Ambrisentan | Ambrisentan 5 mg/1 | Tablet, Film coatedOral | Zydus Lifesciences Limited | 70771-1363 |
| Ambrisentan | Ambrisentan 10 mg/1 | Tablet, Film coatedOral | Zydus Lifesciences Limited | 70771-1364 |
| Ambrisentan | Ambrisentan 10 mg/1 | Tablet, Film coatedOral | Quallent Pharmaceuticals Health LLC | 82009-142 |