Prescription drug · NDA
Entresto (Sacubitril and valsartan) NDC 71610-806
Sacubitril 49 mg/1; Valsartan 51 mg/1 · Tablet, Film coated · Oral · Aphena Pharma Solutions - Tennessee, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71610-806-32 | 7161008063271610080632 | 780 TABLET, FILM COATED in 1 BOTTLE (71610-806-32)Marketed from Mar 22, 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)
- Entresto
- Generic name (nonproprietary)
- sacubitril and valsartan
- Active ingredients
- Sacubitril — 49 mg/1Valsartan — 51 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Aphena Pharma Solutions - Tennessee, LLCNDC labeler code 71610
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 207620
- Marketing start
- Listing expires
- Other FDA classes
- Angiotensin 2 Receptor Antagonists (Mechanism)Neprilysin Inhibitors (Mechanism)
- Identifiers
- Product ID 71610-806_14bf8866-17fa-96ec-e063-6294a90ad420SPL ID 14bf8866-17fa-96ec-e063-6294a90ad420SPL set ID 14bf8041-0b7f-9acb-e063-6294a90a8256RxCUI 1656349, 1656351UNII 17ERJ0MKGI, 80M03YXJ7I
- Pharmacologic class
- Angiotensin 2 Receptor Blocker; Neprilysin Inhibitor
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
N471610080632followed by a unit qualifier and the quantityPackage 71610-0806-32. 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)
ENTRESTO is indicated: to reduce the risk of cardiovascular death and hospitalization for heart failure in adult patients with chronic heart failure. Benefits are most clearly evident in patients with left ventricular ejection fraction (LVEF) below normal. ( 1.1 ) for the treatment of symptomatic heart failure with systemic left ventricular systolic dysfunction in pediatric patients aged one year and older. ENTRESTO reduces NT-proBNP and is expected to improve cardiovascular outcomes. ( 1.2 ) 1.1 Adult Heart Failure ENTRESTO is indicated to reduce the risk of cardiovascular death and hospitalization for heart failure in adult patients with chronic heart failure. Benefits are most clearly evi…
Excerpt only. Read the full label for complete information.
About NDC 71610-806
- What is NDC 71610-806?
- 71610-806 is the product NDC for Entresto, Sacubitril 49 mg/1; Valsartan 51 mg/1 tablet, film coated, listed with the FDA by Aphena Pharma Solutions - Tennessee, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Entresto (Sacubitril and Valsartan).
- What is the active ingredient?
- Sacubitril, Valsartan.
- Who is the labeler?
- Aphena Pharma Solutions - Tennessee, LLC, NDC labeler code 71610. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Entresto?
- 9 other product NDCs are listed under this name. See all Entresto NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Entresto products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Entrestosacubitril and valsartan | Sacubitril 6 mg/1; Valsartan 6 mg/1 | PelletOral | Novartis Pharmaceuticals Corporation | 0078-1231 | 00078-1231-20 |
| Entrestosacubitril and valsartan | Sacubitril 15 mg/1; Valsartan 16 mg/1 | PelletOral | Novartis Pharmaceuticals Corporation | 0078-1238 | 00078-1238-20 |
| Entrestosacubitril and valsartan | Sacubitril 24 mg/1; Valsartan 26 mg/1 | Tablet, Film coatedOral | Novartis Pharmaceuticals Corporation | 0078-0659 | 00078-0659-2000078-0659-67 |
| Entrestosacubitril and valsartan | Sacubitril 97 mg/1; Valsartan 103 mg/1 | Tablet, Film coatedOral | Novartis Pharmaceuticals Corporation | 0078-0696 | 00078-0696-2000078-0696-67 |
| Entrestosacubitril and valsartan | Sacubitril 49 mg/1; Valsartan 51 mg/1 | Tablet, Film coatedOral | Novartis Pharmaceuticals Corporation | 0078-0777 | 00078-0777-2000078-0777-67 |
| Entrestosacubitril and valsartan | Sacubitril 24 mg/1; Valsartan 26 mg/1 | Tablet, Film coatedOral | Novartis Pharmaceuticals Corporation | 0078-9659 | 00078-9659-50 |
| Entrestosacubitril and valsartan | Sacubitril 49 mg/1; Valsartan 51 mg/1 | Tablet, Film coatedOral | Novartis Pharmaceuticals Corporation | 0078-9777 | 00078-9777-50 |
| Entrestosacubitril and valsartan | Sacubitril 97 mg/1; Valsartan 103 mg/1 | Tablet, Film coatedOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-807 | 71610-0807-37 |
| Entrestosacubitril and valsartan | Sacubitril 24 mg/1; Valsartan 26 mg/1 | Tablet, Film coatedOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-810 | 71610-0810-3271610-0810-8871610-0810-89 |
Other NDCs under NDA 207620
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 |
|---|---|---|---|---|
| Entrestosacubitril and valsartan | Sacubitril 24 mg/1; Valsartan 26 mg/1 | Tablet, Film coatedOral | Novartis Pharmaceuticals Corporation | 0078-0659 |
| Entrestosacubitril and valsartan | Sacubitril 97 mg/1; Valsartan 103 mg/1 | Tablet, Film coatedOral | Novartis Pharmaceuticals Corporation | 0078-0696 |
| Entrestosacubitril and valsartan | Sacubitril 49 mg/1; Valsartan 51 mg/1 | Tablet, Film coatedOral | Novartis Pharmaceuticals Corporation | 0078-0777 |
| Entrestosacubitril and valsartan | Sacubitril 24 mg/1; Valsartan 26 mg/1 | Tablet, Film coatedOral | Novartis Pharmaceuticals Corporation | 0078-9659 |
| Entrestosacubitril and valsartan | Sacubitril 49 mg/1; Valsartan 51 mg/1 | Tablet, Film coatedOral | Novartis Pharmaceuticals Corporation | 0078-9777 |
| Entrestosacubitril and valsartan | Sacubitril 97 mg/1; Valsartan 103 mg/1 | Tablet, Film coatedOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-807 |
| Entrestosacubitril and valsartan | Sacubitril 24 mg/1; Valsartan 26 mg/1 | Tablet, Film coatedOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-810 |