Prescription drug · NDA
Entresto (Sacubitril and valsartan) NDC 0078-0659
Sacubitril 24 mg/1; Valsartan 26 mg/1 · Tablet, Film coated · Oral · Novartis Pharmaceuticals Corporation
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0078-0659-20 | 00078065920 | 60 TABLET, FILM COATED in 1 BOTTLE (0078-0659-20)Marketed from Jul 7, 2015 | |
| 0078-0659-67 | 00078065967 | 180 TABLET, FILM COATED in 1 BOTTLE (0078-0659-67)Marketed from Jul 7, 2015 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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 — 24 mg/1Valsartan — 26 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Novartis Pharmaceuticals CorporationNDC labeler code 0078
- 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 0078-0659_27616611-6b9c-4e50-b93b-ed29c24f9857SPL ID 27616611-6b9c-4e50-b93b-ed29c24f9857SPL set ID 000dc81d-ab91-450c-8eae-8eb74e72296fRxCUI 1656340, 1656346, 1656349, 1656351, 1656354, 1656356, 2679793, 2679797, 2679800, 2679802UNII 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
N400078065920followed by a unit qualifier and the quantityPackage 00078-0659-20. 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 a combination of sacubitril, a neprilisin inhibitor, and valsartan, an angiotensin II receptor blocker, and 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 an…
Excerpt only. Read the full label for complete information.
About NDC 0078-0659
- What is NDC 0078-0659?
- 0078-0659 is the product NDC for Entresto, Sacubitril 24 mg/1; Valsartan 26 mg/1 tablet, film coated, listed with the FDA by Novartis Pharmaceuticals Corporation. It has 2 package NDCs, 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?
- Novartis Pharmaceuticals Corporation, NDC labeler code 0078. 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 15 mg/1; Valsartan 16 mg/1 | PelletOral | Novartis Pharmaceuticals Corporation | 0078-1238 | 00078-1238-20 |
| Entrestosacubitril and valsartan | Sacubitril 6 mg/1; Valsartan 6 mg/1 | PelletOral | Novartis Pharmaceuticals Corporation | 0078-1231 | 00078-1231-20 |
| 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 | Novartis Pharmaceuticals Corporation | 0078-0696 | 00078-0696-2000078-0696-67 |
| Entrestosacubitril and valsartan | Sacubitril 49 mg/1; Valsartan 51 mg/1 | Tablet, Film coatedOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-806 | 71610-0806-32 |
| 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 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 | Novartis Pharmaceuticals Corporation | 0078-0696 |
| Entrestosacubitril and valsartan | Sacubitril 49 mg/1; Valsartan 51 mg/1 | Tablet, Film coatedOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-806 |
| 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 |