Prescription drug · ANDA
Sacubitril and Valsartan Sacubitril and Valsartan NDC 43598-644
sacubitril and valsartan · Sacubitril 49 mg/1; Valsartan 51 mg/1 · Tablet, Film coated · Oral · Dr. Reddy's Laboratories Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 43598-644-18 | 43598064418 | 180 TABLET, FILM COATED in 1 BOTTLE (43598-644-18)Marketed from Jul 16, 2025 | |
| 43598-644-60 | 43598064460 | 60 TABLET, FILM COATED in 1 BOTTLE (43598-644-60)Marketed from Jul 16, 2025 |
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)
- Sacubitril and Valsartan Sacubitril and ValsartanSuffix: Sacubitril and Valsartan
- Generic name (nonproprietary)
- sacubitril and valsartan
- Active ingredients
- Sacubitril — 49 mg/1Valsartan — 51 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 213627
- Marketing start
- Listing expires
- Other FDA classes
- Angiotensin 2 Receptor Antagonists (Mechanism)Neprilysin Inhibitors (Mechanism)
- Identifiers
- Product ID 43598-644_2745b697-4155-c757-7e40-826bf72e469dSPL ID 2745b697-4155-c757-7e40-826bf72e469dSPL set ID f4789255-b59b-544b-bbbe-2edd07da6079RxCUI 1656340, 1656349, 1656354UNII 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
N443598064418followed by a unit qualifier and the quantityPackage 43598-0644-18. 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 tablet is a combination of sacubitril, a neprilysin 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 valsa…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 213627
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 and Valsartansacubitril and valsartan | Sacubitril 24 mg/1; Valsartan 26 mg/1 | Tablet, Film coatedOral | Dr. Reddy's Laboratories Inc. | 43598-643 |
| Sacubitril and Valsartan Sacubitril and Valsartansacubitril and valsartan | Sacubitril 97 mg/1; Valsartan 103 mg/1 | Tablet, Film coatedOral | Dr. Reddy's Laboratories Inc. | 43598-645 |