What is NDC 53746-837?

53746-837 is the product NDC for Valsartan, Valsartan 40 mg/1 tablet, listed with the FDA by Amneal Pharmaceuticals of New York LLC. It has 3 package NDCs, shown above in 10- and 11-digit form.

Amneal Pharmaceuticals of New York LLC, NDC labeler code 53746. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Valsartan?

130 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Valsartan NDC 53746-837 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)53746-837Labeler and product segments. Claims need a package NDC.

Product NDC at billing width53746-0837Add 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
53746-837-05	5374608370553746083705	500 TABLET in 1 BOTTLE (53746-837-05)Marketed from Aug 1, 2023
53746-837-30	5374608373053746083730	30 TABLET in 1 BOTTLE (53746-837-30)Marketed from Aug 1, 2023
53746-837-60	5374608376053746083760	60 TABLET in 1 BOTTLE (53746-837-60)Marketed from Aug 1, 2023

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): Valsartan
Generic name (nonproprietary): valsartan
Active ingredients: Valsartan — 40 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Amneal Pharmaceuticals of New York LLCNDC labeler code 53746
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 204011
Marketing start: Aug 1, 2023
Listing expires: Dec 31, 2027
Other FDA classes: Angiotensin 2 Receptor Antagonists (Mechanism)
Identifiers: Product ID 53746-837_254b9473-bbcb-4780-a182-ba287b886a47SPL ID 254b9473-bbcb-4780-a182-ba287b886a47SPL set ID f13587f8-76cb-49ad-9291-5907249d6b8eRxCUI 349199, 349200, 349201, 349483UNII 80M03YXJ7IUPC 0353746840905, 0353746838902, 0353746837301
Pharmacologic class: Angiotensin 2 Receptor Blocker

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

N453746083705 followed by a unit qualifier and the quantity

Package 53746-0837-05. 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 Dec 14, 2023. This label includes a boxed warning.

Indications (excerpt from the label)

Valsartan tablets are an angiotensin II receptor blocker (ARB) indicated for: Hypertension , to lower blood pressure in adults and children 6 years and older. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. ( 1.1 ) Heart failure (NYHA class II-IV), to reduce hospitalization for heart failure in adults. ( 1.2 ) Post-myocardial infarction , for the reduction of cardiovascular mortality in clinically stable patients with left ventricular failure or left ventricular dysfunction following myocardial infarction in adults. ( 1.3 ) 1.1 Hypertension Valsartan tablets are indicated for the treatment of hypertension, to…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 53746-837

What is NDC 53746-837?: 53746-837 is the product NDC for Valsartan, Valsartan 40 mg/1 tablet, listed with the FDA by Amneal Pharmaceuticals of New York LLC. It has 3 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Valsartan.
What is the active ingredient?: Valsartan.
Who is the labeler?: Amneal Pharmaceuticals of New York LLC, NDC labeler code 53746. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Valsartan?: 130 other product NDCs are listed under this name. See all 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 Valsartan NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
valsartan	Valsartan 320 mg/1	TabletOral	Jubilant Cadista Pharmaceuticals Inc.	59746-393	59746-0393-3059746-0393-3259746-0393-67+1 more
Valsartan	Valsartan 40 mg/1	Tablet, Film coatedOral	Laurus Labs Limited	42385-989	42385-0989-0542385-0989-3042385-0989-68
Valsartan	Valsartan 80 mg/1	Tablet, Film coatedOral	Laurus Labs Limited	42385-990	42385-0990-0542385-0990-3042385-0990-68+1 more
Valsartan	Valsartan 160 mg/1	Tablet, Film coatedOral	Laurus Labs Limited	42385-991	42385-0991-0542385-0991-3042385-0991-68+1 more
Valsartan	Valsartan 320 mg/1	Tablet, Film coatedOral	Laurus Labs Limited	42385-992	42385-0992-0542385-0992-3042385-0992-68+1 more
Valsartan	Valsartan 80 mg/1	Tablet, Film coatedOral	Coupler LLC	67046-1596	67046-1596-03
Valsartan	Valsartan 320 mg/1	Tablet, Film coatedOral	Coupler LLC	67046-1574	67046-1574-03
Valsartanvalsartan oral	Valsartan 4 mg/mL	SolutionOral	Advagen Pharma Ltd	72888-184	72888-0184-1372888-0184-48
Valsartan	Valsartan 40 mg/1	Tablet, Film coatedOral	Zydus Lifesciences Limited	70771-1882	70771-1882-03
Valsartan	Valsartan 80 mg/1	Tablet, Film coatedOral	Zydus Lifesciences Limited	70771-1883	70771-1883-09

All 131 Valsartan NDCs

Other NDCs under ANDA 204011

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

FDA NDC Directory listings under ANDA 204011
Product	Strength	Form · route	Labeler	Product NDC
Valsartan	Valsartan 40 mg/1	TabletOral	AvKARE	42291-856
Valsartan	Valsartan 80 mg/1	TabletOral	AvKARE	42291-857
Valsartan	Valsartan 160 mg/1	TabletOral	AvKARE	42291-858
Valsartan	Valsartan 320 mg/1	TabletOral	AvKARE	42291-859
Valsartan	Valsartan 80 mg/1	TabletOral	Aphena Pharma Solutions - Tennessee, LLC	53401-029
Valsartan	Valsartan 40 mg/1	TabletOral	Aphena Pharma Solutions - Tennessee, LLC	53401-033
Valsartan	Valsartan 80 mg/1	TabletOral	Amneal Pharmaceuticals of New York LLC	53746-838
Valsartan	Valsartan 160 mg/1	TabletOral	Amneal Pharmaceuticals of New York LLC	53746-839
Valsartan	Valsartan 320 mg/1	TabletOral	Amneal Pharmaceuticals of New York LLC	53746-840
Valsartan	Valsartan 40 mg/1	TabletOral	Amneal Pharmaceuticals LLC	65162-837
Valsartan	Valsartan 80 mg/1	TabletOral	Amneal Pharmaceuticals LLC	65162-838
Valsartan	Valsartan 160 mg/1	TabletOral	Amneal Pharmaceuticals LLC	65162-839
Valsartan	Valsartan 320 mg/1	TabletOral	Amneal Pharmaceuticals LLC	65162-840