Prescription drug · ANDA
sacubitril and valsartan NDC 13668-636
Sacubitril 97 mg/1; Valsartan 103 mg/1 · Tablet · Oral · Torrent Pharmaceuticals Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 13668-636-05 | 13668063605 | 500 TABLET in 1 BOTTLE (13668-636-05)Marketed from Jul 16, 2025 | |
| 13668-636-33 | 13668063633 | 180 TABLET in 1 BOTTLE (13668-636-33)Marketed from Jul 16, 2025 | |
| 13668-636-60 | 13668063660 | 60 TABLET in 1 BOTTLE (13668-636-60)Marketed from Jul 16, 2025 | |
| 13668-636-74 | 13668063674 | 100 BLISTER PACK in 1 CARTON (13668-636-74) / 10 TABLET in 1 BLISTER PACK (13668-636-71)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
- 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 213604
- Marketing start
- Marketing end
- Other FDA classes
- Angiotensin 2 Receptor Antagonists (Mechanism)Neprilysin Inhibitors (Mechanism)
- Identifiers
- Product ID 13668-636_3876b6f1-ea3c-4aa1-a1ee-876e32efc629SPL ID 3876b6f1-ea3c-4aa1-a1ee-876e32efc629SPL set ID 59b7a07a-96ee-44b1-8dae-2b42169aa2c5RxCUI 1656340, 1656349, 1656354UNII 17ERJ0MKGI, 80M03YXJ7IUPC 0313668635607, 0313668746600, 0313668747607
- 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
N413668063605followed by a unit qualifier and the quantityPackage 13668-0636-05. 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 213604
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 | TabletOral | Torrent Pharmaceuticals Limited | 13668-746 |
| sacubitril and valsartan | Sacubitril 97 mg/1; Valsartan 103 mg/1 | TabletOral | Torrent Pharmaceuticals Limited | 13668-747 |
| sacubitril and valsartan | Sacubitril 49 mg/1; Valsartan 51 mg/1 | TabletOral | Torrent Pharmaceuticals Limited | 13668-635 |
| sacubitril and valsartan | Sacubitril 24 mg/1; Valsartan 26 mg/1 | TabletOral | Torrent Pharmaceuticals Limited | 13668-634 |