What is NDC 71610-982?

71610-982 is the product NDC for Sacubitril and Valsartan, Sacubitril 49 mg/1; Valsartan 51 mg/1 tablet, listed with the FDA by Aphena Pharma Solutions - Tennessee, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

Aphena Pharma Solutions - Tennessee, LLC, NDC labeler code 71610. 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.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Sacubitril and Valsartan NDC 71610-982

NDC codes

FDA NDC Directory

Product NDC (as listed)71610-982Labeler and product segments. Claims need a package NDC.

Product NDC at billing width71610-0982Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
71610-982-89	7161009828971610098289	720 TABLET in 1 BOTTLE (71610-982-89)Marketed from Jan 14, 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
Route: Oral
Labeler: Aphena Pharma Solutions - Tennessee, LLCNDC labeler code 71610
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 213728
Marketing start: Sep 30, 2025
Listing expires: Dec 31, 2027
Other FDA classes: Angiotensin 2 Receptor Antagonists (Mechanism)Neprilysin Inhibitors (Mechanism)
Identifiers: Product ID 71610-982_48714aae-1dc8-dd89-e063-6294a90a73e6SPL ID 48714aae-1dc8-dd89-e063-6294a90a73e6SPL set ID 48714b95-b4ac-ef3c-e063-6294a90a9a5bRxCUI 1656349UNII 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

N471610098289 followed by a unit qualifier and the quantity

Package 71610-0982-89. 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 Jan 15, 2026. 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 sacubitril and valsartan tablets are 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 reduces NT-proBNP and is expected to improve cardiovascular outcomes. ( 1.2 ) 1.1 Adult He…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 71610-982

What is NDC 71610-982?: 71610-982 is the product NDC for Sacubitril and Valsartan, Sacubitril 49 mg/1; Valsartan 51 mg/1 tablet, listed with the FDA by Aphena Pharma Solutions - Tennessee, LLC. It has 1 package NDC, 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?: Aphena Pharma Solutions - Tennessee, LLC, NDC labeler code 71610. 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.

Other finished products listed under the same name: strengths, forms and labelers.

Other Sacubitril and Valsartan NDCs
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 24 mg/1; Valsartan 26 mg/1	Tablet, Film coatedOral	Aurobindo Pharma Limited	84386-081	84386-0081-1884386-0081-6084386-0081-78
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

All 90 Sacubitril and Valsartan NDCs

Other NDCs under ANDA 213728

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 213728
Product	Strength	Form · route	Labeler	Product NDC
Sacubitril and Valsartan	Sacubitril 24 mg/1; Valsartan 26 mg/1	TabletOral	Macleods Pharmaceuticals Limited	33342-570
Sacubitril and Valsartan	Sacubitril 49 mg/1; Valsartan 51 mg/1	TabletOral	Macleods Pharmaceuticals Limited	33342-571
Sacubitril and Valsartan	Sacubitril 97 mg/1; Valsartan 103 mg/1	TabletOral	Macleods Pharmaceuticals Limited	33342-572
Sacubitril and Valsartan	Sacubitril 24 mg/1; Valsartan 26 mg/1	TabletOral	Aphena Pharma Solutions - Tennessee, LLC	71610-983
Sacubitril and Valsartan	Sacubitril 97 mg/1; Valsartan 103 mg/1	TabletOral	Aphena Pharma Solutions - Tennessee, LLC	71610-984
Sacubitril and Valsartan	Sacubitril 24 mg/1; Valsartan 26 mg/1	Tablet, Film coatedOral	NorthStar RxLLC	72603-880
Sacubitril and Valsartan	Sacubitril 49 mg/1; Valsartan 51 mg/1	Tablet, Film coatedOral	NorthStar RxLLC	72603-881
Sacubitril and Valsartan	Sacubitril 97 mg/1; Valsartan 103 mg/1	Tablet, Film coatedOral	NorthStar RxLLC	72603-882
Sacubitril and Valsartan	Sacubitril 24 mg/1; Valsartan 26 mg/1	TabletOral	XLCare Pharmaceuticals Inc	72865-310
Sacubitril and Valsartan	Sacubitril 49 mg/1; Valsartan 51 mg/1	TabletOral	XLCare Pharmaceuticals Inc	72865-311
Sacubitril and Valsartan	Sacubitril 97 mg/1; Valsartan 103 mg/1	TabletOral	XLCare Pharmaceuticals Inc	72865-312