Prescription drug · ANDA
Sacubitril and Valsartan NDC 70954-976
Sacubitril 49 mg/1; Valsartan 51 mg/1 · Tablet, Film coated · Oral · ANI Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70954-976-20 | 70954097620 | 60 TABLET, FILM COATED in 1 BOTTLE (70954-976-20)Marketed from Jul 24, 2025 | |
| 70954-976-30 | 70954097630 | 180 TABLET, FILM COATED in 1 BOTTLE (70954-976-30)Marketed from Jul 24, 2025 | |
| 70954-976-50 | 70954097650 | 1000 TABLET, FILM COATED in 1 BOTTLE (70954-976-50)Marketed from May 27, 2026 |
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 — 49 mg/1Valsartan — 51 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- ANI Pharmaceuticals, Inc.NDC labeler code 70954
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 213676
- Marketing start
- Listing expires
- Other FDA classes
- Angiotensin 2 Receptor Antagonists (Mechanism)Neprilysin Inhibitors (Mechanism)
- Identifiers
- Product ID 70954-976_fb8d85f8-7a85-422b-82f0-2a4f5d296b07SPL ID fb8d85f8-7a85-422b-82f0-2a4f5d296b07SPL set ID a1fa7066-8ab4-47e3-a701-6c5170700d11RxCUI 1656340, 1656349, 1656354UNII 17ERJ0MKGI, 80M03YXJ7IUPC 0370954977506, 0370954976202, 0370954977308, 0370954977209, 0370954975205, 0370954975304, 0370954975502, 0370954976509, 0370954976301
- 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
N470954097620followed by a unit qualifier and the quantityPackage 70954-0976-20. 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)
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 reduce NT-proBNP and are expected to improve cardiovascular outcomes. (1.2) 1.1 Adult Heart Failure Sacubitril and valsart…
Excerpt only. Read the full label for complete information.
About NDC 70954-976
- What is NDC 70954-976?
- 70954-976 is the product NDC for Sacubitril and Valsartan, Sacubitril 49 mg/1; Valsartan 51 mg/1 tablet, film coated, listed with the FDA by ANI Pharmaceuticals, Inc.. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Sacubitril and Valsartan.
- What is the active ingredient?
- Sacubitril, Valsartan.
- Who is the labeler?
- ANI Pharmaceuticals, Inc., NDC labeler code 70954. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Sacubitril and Valsartan?
- 86 other product NDCs are listed under this name. See all Sacubitril and Valsartan NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Sacubitril and Valsartan products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Sacubitril and Valsartan | Sacubitril 24 mg/1; Valsartan 26 mg/1 | Tablet, Film coatedOral | Umedica Laboratories USA Inc. | 60290-085 | 60290-0085-0160290-0085-0260290-0085-03 |
| Sacubitril and Valsartan | Sacubitril 49 mg/1; Valsartan 51 mg/1 | Tablet, Film coatedOral | Umedica Laboratories USA Inc. | 60290-086 | 60290-0086-0160290-0086-0260290-0086-03 |
| Sacubitril and Valsartan | Sacubitril 97 mg/1; Valsartan 103 mg/1 | Tablet, Film coatedOral | Umedica Laboratories USA Inc. | 60290-087 | 60290-0087-0160290-0087-0260290-0087-03 |
| Sacubitril and Valsartan | Sacubitril 97 mg/1; Valsartan 103 mg/1 | Tablet, Film coatedOral | NorthStar RxLLC | 72603-882 | 72603-0882-0172603-0882-02 |
| Sacubitril and Valsartan | Sacubitril 24 mg/1; Valsartan 26 mg/1 | Tablet, Film coatedOral | NorthStar RxLLC | 72603-880 | 72603-0880-0172603-0880-02 |
| Sacubitril and Valsartan | Sacubitril 49 mg/1; Valsartan 51 mg/1 | Tablet, Film coatedOral | NorthStar RxLLC | 72603-881 | 72603-0881-0172603-0881-02 |
| sacubitril and valsartan | Sacubitril 49 mg/1; Valsartan 51 mg/1 | Tablet, Film coatedOral | Golden State Medical Supply, Inc. | 51407-936 | 51407-0936-10 |
| sacubitril and valsartan | Sacubitril 24 mg/1; Valsartan 26 mg/1 | Tablet, Film coatedOral | Golden State Medical Supply, Inc. | 51407-935 | 51407-0935-10 |
| sacubitril and valsartan | Sacubitril 97 mg/1; Valsartan 103 mg/1 | Tablet, Film coatedOral | Golden State Medical Supply, Inc. | 51407-937 | 51407-0937-10 |
| Sacubitril and Valsartan | Sacubitril 49 mg/1; Valsartan 51 mg/1 | Tablet, Film coatedOral | American Health Packaging | 60687-966 | 60687-0966-57 |
Other NDCs under ANDA 213676
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 | Tablet, Film coatedOral | ANI Pharmaceuticals, Inc. | 70954-975 |
| Sacubitril and Valsartan | Sacubitril 97 mg/1; Valsartan 103 mg/1 | Tablet, Film coatedOral | ANI Pharmaceuticals, Inc. | 70954-977 |
| Sacubitril and Valsartan | Sacubitril 97 mg/1; Valsartan 103 mg/1 | Tablet, Film coatedOral | Laurus Labs Limited | 42385-932 |
| Sacubitril and Valsartan | Sacubitril 24 mg/1; Valsartan 26 mg/1 | Tablet, Film coatedOral | Laurus Labs Limited | 42385-930 |
| Sacubitril and Valsartan | Sacubitril 49 mg/1; Valsartan 51 mg/1 | Tablet, Film coatedOral | Laurus Labs Limited | 42385-931 |