Prescription drug · ANDA
Ambrisentan NDC 70710-1180
Ambrisentan 10 mg/1 · Tablet, Film coated · Oral · Zydus Pharmaceuticals USA Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70710-1180-1 | 70710118001 | 100 TABLET, FILM COATED in 1 BOTTLE (70710-1180-1)Marketed from Apr 12, 2019 | |
| 70710-1180-3 | 70710118003 | 30 TABLET, FILM COATED in 1 BOTTLE (70710-1180-3)Marketed from Apr 12, 2019 | |
| 70710-1180-7 | 70710118007 | 1 BLISTER PACK in 1 CARTON (70710-1180-7) / 10 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Apr 12, 2019 | |
| 70710-1180-8 | 70710118008 | 3 BLISTER PACK in 1 CARTON (70710-1180-8) / 10 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Apr 12, 2019 | |
| 70710-1180-9 | 70710118009 | 90 TABLET, FILM COATED in 1 BOTTLE (70710-1180-9)Marketed from Apr 12, 2019 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 — 10 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- 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 70710-1180_2b40da77-ad23-44bc-8556-1039a299da4cSPL ID 2b40da77-ad23-44bc-8556-1039a299da4cSPL set ID 37af3191-0ed3-4783-8747-065f1462f2d2RxCUI 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
N470710118001followed by a unit qualifier and the quantityPackage 70710-1180-01. 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.
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 5 mg/1 | Tablet, Film coatedOral | Quallent Pharmaceuticals Health LLC | 82009-141 |
| Ambrisentan | Ambrisentan 10 mg/1 | Tablet, Film coatedOral | Quallent Pharmaceuticals Health LLC | 82009-142 |
| 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 |