What is NDC 33342-572?

33342-572 is the product NDC for Sacubitril and Valsartan, Sacubitril 97 mg/1; Valsartan 103 mg/1 tablet, listed with the FDA by Macleods Pharmaceuticals Limited. It has 2 package NDCs, shown above in 10- and 11-digit form.

Macleods Pharmaceuticals Limited, NDC labeler code 33342. 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 33342-572

NDC codes

FDA NDC Directory

Product NDC (as listed)33342-572Labeler and product segments. Claims need a package NDC.

Product NDC at billing width33342-0572Add 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
33342-572-09	3334205720933342057209	60 TABLET in 1 BOTTLE (33342-572-09)Marketed from Oct 16, 2024
33342-572-57	3334205725733342057257	180 TABLET in 1 BOTTLE (33342-572-57)Marketed from Oct 16, 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 — 97 mg/1Valsartan — 103 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Macleods Pharmaceuticals LimitedNDC labeler code 33342
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 213728
Marketing start: Oct 16, 2024
Listing expires: Dec 31, 2026
Other FDA classes: Angiotensin 2 Receptor Antagonists (Mechanism)Neprilysin Inhibitors (Mechanism)
Identifiers: Product ID 33342-572_103c39e2-f3c8-40fc-a57e-3af018fb4af4SPL ID 103c39e2-f3c8-40fc-a57e-3af018fb4af4SPL set ID 103c39e2-f3c8-40fc-a57e-3af018fb4af4RxCUI 1656340, 1656349, 1656354UNII 17ERJ0MKGI, 80M03YXJ7IUPC 0333342570574, 0333342570093, 0333342571571, 0333342571090, 0333342572097
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

N433342057209 followed by a unit qualifier and the quantity

Package 33342-0572-09. 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 Jun 26, 2025. 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 33342-572

What is NDC 33342-572?: 33342-572 is the product NDC for Sacubitril and Valsartan, Sacubitril 97 mg/1; Valsartan 103 mg/1 tablet, listed with the FDA by Macleods Pharmaceuticals Limited. It has 2 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?: Macleods Pharmaceuticals Limited, NDC labeler code 33342. 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 49 mg/1; Valsartan 51 mg/1	TabletOral	Aphena Pharma Solutions - Tennessee, LLC	71610-982
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