Sacubitril and Valsartan NDC 42385-931

NDC codes

FDA NDC Directory

Product NDC (as listed)42385-931Labeler and product segments. Claims need a package NDC.

Product NDC at billing width42385-0931Add 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
42385-931-18	42385093118	180 TABLET, FILM COATED in 1 BOTTLE (42385-931-18)Marketed from Nov 11, 2024
42385-931-30	42385093130	30 TABLET, FILM COATED in 1 BOTTLE (42385-931-30)Marketed from Nov 11, 2024
42385-931-60	42385093160	60 TABLET, FILM COATED in 1 BOTTLE (42385-931-60)Marketed from Nov 11, 2024
42385-931-68	42385093168	100 BLISTER PACK in 1 CARTON (42385-931-68) / 10 TABLET, FILM COATED in 1 BLISTER PACK (42385-931-10)Marketed from Nov 11, 2024
42385-931-72	42385093172	100 BLISTER PACK in 1 CARTON (42385-931-72) / 10 TABLET, FILM COATED in 1 BLISTER PACK (42385-931-17)Marketed from Nov 11, 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 — 49 mg/1Valsartan — 51 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Laurus Labs Limited
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 213676
Marketing start: Nov 11, 2024
Listing expires: Dec 31, 2026
Other FDA classes: Angiotensin 2 Receptor Antagonists (Mechanism)Neprilysin Inhibitors (Mechanism)
Identifiers: Product ID 42385-931_b47b5c7e-1c20-429c-9560-07f5f06cdce3SPL ID b47b5c7e-1c20-429c-9560-07f5f06cdce3SPL set ID b47b5c7e-1c20-429c-9560-07f5f06cdce3RxCUI 1656340, 1656349, 1656354UNII 80M03YXJ7I, 17ERJ0MKGIUPC 0342385932102, 0342385932300, 0342385930306, 0342385931303
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

N442385093118 followed by a unit qualifier and the quantity

Package 42385-0931-18. 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

Current FDA label (SPL), effective Nov 7, 2024. 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.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 213676

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

FDA NDC Directory listings under ANDA 213676
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 49 mg/1; Valsartan 51 mg/1	Tablet, Film coatedOral	ANI Pharmaceuticals, Inc.	70954-976
Sacubitril and Valsartan	Sacubitril 97 mg/1; Valsartan 103 mg/1	Tablet, Film coatedOral	ANI Pharmaceuticals, Inc.	70954-977
Sacubitril and Valsartan	Sacubitril 24 mg/1; Valsartan 26 mg/1	Tablet, Film coatedOral	Laurus Labs Limited	42385-930
Sacubitril and Valsartan	Sacubitril 97 mg/1; Valsartan 103 mg/1	Tablet, Film coatedOral	Laurus Labs Limited	42385-932