Prescription drug · ANDA
Ambrisentan NDC 70771-1364
Ambrisentan 10 mg/1 · Tablet, Film coated · Oral · Zydus Lifesciences Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70771-1364-1 | 70771136401 | 100 TABLET, FILM COATED in 1 BOTTLE (70771-1364-1)Marketed from Apr 12, 2019 | |
| 70771-1364-3 | 70771136403 | 30 TABLET, FILM COATED in 1 BOTTLE (70771-1364-3)Marketed from Apr 12, 2019 | |
| 70771-1364-7 | 70771136407 | 1 BLISTER PACK in 1 CARTON (70771-1364-7) / 10 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Apr 12, 2019 | |
| 70771-1364-8 | 70771136408 | 3 BLISTER PACK in 1 CARTON (70771-1364-8) / 10 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Apr 12, 2019 | |
| 70771-1364-9 | 70771136409 | 90 TABLET, FILM COATED in 1 BOTTLE (70771-1364-9)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
- Labeler
- Zydus Lifesciences Limited
- 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 70771-1364_14a85c38-61bf-4621-8e3a-34ab57a15758SPL ID 14a85c38-61bf-4621-8e3a-34ab57a15758SPL set ID 0e3e3320-27ac-404f-9f01-3d82696e768aRxCUI 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
N470771136401followed by a unit qualifier and the quantityPackage 70771-1364-01. 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 .
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 10 mg/1 | Tablet, Film coatedOral | Zydus Pharmaceuticals USA Inc. | 70710-1180 |
| 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 |