Prescription drug · ANDA
Sacubitril and Valsartan NDC 84386-081
Sacubitril 24 mg/1; Valsartan 26 mg/1 · Tablet, Film coated · Oral · Aurobindo Pharma Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 84386-081-18 | 8438600811884386008118 | 180 TABLET, FILM COATED in 1 BOTTLE (84386-081-18)Marketed from Oct 26, 2026 | |
| 84386-081-60 | 8438600816084386008160 | 60 TABLET, FILM COATED in 1 BOTTLE (84386-081-60)Marketed from Oct 26, 2026 | |
| 84386-081-78 | 8438600817884386008178 | 10 BLISTER PACK in 1 CARTON (84386-081-78) / 10 TABLET, FILM COATED in 1 BLISTER PACK (84386-081-10)Marketed from Oct 26, 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 — 24 mg/1Valsartan — 26 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Aurobindo Pharma LimitedNDC labeler code 84386
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 213631
- Marketing start
- Listing expires
- Other FDA classes
- Angiotensin 2 Receptor Antagonists (Mechanism)Neprilysin Inhibitors (Mechanism)
- Identifiers
- Product ID 84386-081_ccfa182e-8a23-42e1-9062-be2655c96208SPL ID ccfa182e-8a23-42e1-9062-be2655c96208
- 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
N484386008118followed by a unit qualifier and the quantityPackage 84386-0081-18. 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
The FDA listing for this product does not reference a label (SPL) set.
About NDC 84386-081
- What is NDC 84386-081?
- 84386-081 is the product NDC for Sacubitril and Valsartan, Sacubitril 24 mg/1; Valsartan 26 mg/1 tablet, film coated, listed with the FDA by Aurobindo Pharma Limited. 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?
- Aurobindo Pharma Limited, NDC labeler code 84386. 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?
- 89 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 49 mg/1; Valsartan 51 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 84386-082 | 84386-0082-1884386-0082-6084386-0082-78 |
| Sacubitril and Valsartan | Sacubitril 97 mg/1; Valsartan 103 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 84386-083 | 84386-0083-1884386-0083-6084386-0083-78 |
| 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 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 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 97 mg/1; Valsartan 103 mg/1 | Tablet, Film coatedOral | NorthStar RxLLC | 72603-882 | 72603-0882-0172603-0882-02 |
| 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 24 mg/1; Valsartan 26 mg/1 | Tablet, Film coatedOral | Golden State Medical Supply, Inc. | 51407-935 | 51407-0935-10 |
Other NDCs under ANDA 213631
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 | Aurobindo Pharma Limited | 84386-082 |
| Sacubitril and Valsartan | Sacubitril 97 mg/1; Valsartan 103 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 84386-083 |