Prescription drug · ANDA
sacubitril and valsartan NDC 62332-556
Sacubitril 24 mg/1; Valsartan 26 mg/1 · Tablet, Film coated · Oral · Alembic Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 62332-556-10 | 62332055610 | 100 BLISTER PACK in 1 CARTON (62332-556-10) / 10 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Nov 4, 2024 | |
| 62332-556-45 | 62332055645 | 180 TABLET, FILM COATED in 1 BOTTLE (62332-556-45)Marketed from Nov 4, 2024 | |
| 62332-556-60 | 62332055660 | 60 TABLET, FILM COATED in 1 BOTTLE (62332-556-60)Marketed from Nov 4, 2024 | |
| 62332-556-91 | 62332055691 | 1000 TABLET, FILM COATED in 1 BOTTLE (62332-556-91)Marketed from Nov 4, 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)
- sacubitril and valsartan
- Generic name (nonproprietary)
- sacubitril and valsartan
- Active ingredients
- Sacubitril — 24 mg/1Valsartan — 26 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Alembic Pharmaceuticals Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 213682
- Marketing start
- Listing expires
- Other FDA classes
- Angiotensin 2 Receptor Antagonists (Mechanism)Neprilysin Inhibitors (Mechanism)
- Identifiers
- Product ID 62332-556_3b7867cd-b65b-47b7-a000-f31f04a564aaSPL ID 3b7867cd-b65b-47b7-a000-f31f04a564aaSPL set ID 5928f174-83e5-4c74-b15a-138338a70295RxCUI 1656340, 1656349, 1656354UNII 80M03YXJ7I, 17ERJ0MKGIUPC 0362332558605
- 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
N462332055610followed by a unit qualifier and the quantityPackage 62332-0556-10. 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 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 tablet reduce 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 213682
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 49 mg/1; Valsartan 51 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Inc. | 62332-557 |
| sacubitril and valsartan | Sacubitril 97 mg/1; Valsartan 103 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Inc. | 62332-558 |
| sacubitril and valsartan | Sacubitril 24 mg/1; Valsartan 26 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Limited | 46708-556 |
| sacubitril and valsartan | Sacubitril 49 mg/1; Valsartan 51 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Limited | 46708-557 |
| sacubitril and valsartan | Sacubitril 97 mg/1; Valsartan 103 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Limited | 46708-558 |
| sacubitril and valsartan | Sacubitril 24 mg/1; Valsartan 26 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-1624 |
| sacubitril and valsartan | Sacubitril 24 mg/1; Valsartan 26 mg/1 | Tablet, Film coatedOral | Golden State Medical Supply, Inc. | 51407-935 |
| sacubitril and valsartan | Sacubitril 49 mg/1; Valsartan 51 mg/1 | Tablet, Film coatedOral | Golden State Medical Supply, Inc. | 51407-936 |
| sacubitril and valsartan | Sacubitril 97 mg/1; Valsartan 103 mg/1 | Tablet, Film coatedOral | Golden State Medical Supply, Inc. | 51407-937 |