Prescription drug · ANDA
sacubitril and valsartan NDC 70710-1274
Sacubitril 97 mg/1; Valsartan 103 mg/1 · Tablet · Oral · Zydus Pharmaceuticals USA Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70710-1274-4 | 70710127404 | 10 BLISTER PACK in 1 CARTON (70710-1274-4) / 10 TABLET in 1 BLISTER PACK (70710-1274-2)Marketed from Jul 8, 2025 | |
| 70710-1274-6 | 70710127406 | 60 TABLET in 1 BOTTLE (70710-1274-6)Marketed from Jul 8, 2025 | |
| 70710-1274-8 | 70710127408 | 180 TABLET in 1 BOTTLE (70710-1274-8)Marketed from Jul 8, 2025 |
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)
- sacubitril and valsartan
- Generic name (nonproprietary)
- sacubitril and valsartan
- Active ingredients
- Sacubitril — 97 mg/1Valsartan — 103 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 213719
- Marketing start
- Listing expires
- Other FDA classes
- Angiotensin 2 Receptor Antagonists (Mechanism)Neprilysin Inhibitors (Mechanism)
- Identifiers
- Product ID 70710-1274_581c1ab7-7950-4524-a47a-de378f5ee9ecSPL ID 581c1ab7-7950-4524-a47a-de378f5ee9ecSPL set ID 4ed0dbe4-8752-43c5-8c28-17c9638a52d6RxCUI 1656340, 1656349, 1656354UNII 80M03YXJ7I, 17ERJ0MKGI
- 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
N470710127404followed by a unit qualifier and the quantityPackage 70710-1274-04. 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)
Sacubitril and valsartan tablets are 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. Sacubitril and valsartan tablets reduces NT-proBNP and is expected to improve cardiovascular outcomes. ( 1.2 ) 1.1 Adult Heart Failure Sacubitril and val…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 213719
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 |
|---|---|---|---|---|
| sacubitril and valsartan | Sacubitril 24 mg/1; Valsartan 26 mg/1 | TabletOral | Zydus Pharmaceuticals USA Inc. | 70710-1272 |
| sacubitril and valsartan | Sacubitril 49 mg/1; Valsartan 51 mg/1 | TabletOral | Zydus Pharmaceuticals USA Inc. | 70710-1273 |
| sacubitril and valsartan | Sacubitril 97 mg/1; Valsartan 103 mg/1 | TabletOral | Zydus Lifesciences Limited | 70771-1923 |
| sacubitril and valsartan | Sacubitril 24 mg/1; Valsartan 26 mg/1 | TabletOral | Zydus Lifesciences Limited | 70771-1921 |
| sacubitril and valsartan | Sacubitril 49 mg/1; Valsartan 51 mg/1 | TabletOral | Zydus Lifesciences Limited | 70771-1922 |