What is NDC 53746-845?

53746-845 is the product NDC for Valsartan and Hydrochlorothiazide, Valsartan 80 mg/1; Hydrochlorothiazide 12.5 mg/1 tablet, film coated, listed with the FDA by Amneal Pharmaceuticals of New York LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

What is the active ingredient?

Valsartan, Hydrochlorothiazide.

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 and Hydrochlorothiazide?

98 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Valsartan and Hydrochlorothiazide NDC 53746-845

NDC codes

FDA NDC Directory

Product NDC (as listed)53746-845Labeler and product segments. Claims need a package NDC.

Product NDC at billing width53746-0845Add 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
53746-845-90	5374608459053746084590	90 TABLET, FILM COATED in 1 BOTTLE (53746-845-90)Marketed from Aug 14, 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 and Hydrochlorothiazide
Generic name (nonproprietary): valsartan and hydrochlorothiazide
Active ingredients: Valsartan — 80 mg/1Hydrochlorothiazide — 12.5 mg/1
Dosage form: Tablet, Film coated
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 204382
Marketing start: Aug 14, 2023
Listing expires: Dec 31, 2027
Other FDA classes: Angiotensin 2 Receptor Antagonists (Mechanism)Increased Diuresis (Physiologic effect)Thiazides (Chemical structure)
Identifiers: Product ID 53746-845_1ed15f09-2051-401f-a320-5f04b85ac8e2SPL ID 1ed15f09-2051-401f-a320-5f04b85ac8e2SPL set ID d5a1db33-3046-407c-a557-6b41642164a9RxCUI 200284, 200285, 349353, 636042, 636045UNII 80M03YXJ7I, 0J48LPH2THUPC 0353746848901, 0353746845900, 0353746849908, 0353746847904, 0353746846907
Pharmacologic class: Angiotensin 2 Receptor Blocker; Thiazide Diuretic

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

N453746084590 followed by a unit qualifier and the quantity

Package 53746-0845-90. 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 May 8, 2023. This label includes a boxed warning.

Indications (excerpt from the label)

Valsartan and hydrochlorothiazide tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes, including hydrochlorothiazide and the angiotensin II receptor blocker (ARB) class to which valsartan principally belongs. There are no controlled trials demonstrating risk reduction with valsartan and hydrochlorothiazide tablets. Control of high blood pressure should be part of comprehensive cardiovascular risk management, incl…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 53746-845

What is NDC 53746-845?: 53746-845 is the product NDC for Valsartan and Hydrochlorothiazide, Valsartan 80 mg/1; Hydrochlorothiazide 12.5 mg/1 tablet, film coated, listed with the FDA by Amneal Pharmaceuticals of New York LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Valsartan and Hydrochlorothiazide.
What is the active ingredient?: Valsartan, Hydrochlorothiazide.
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 and Hydrochlorothiazide?: 98 other product NDCs are listed under this name. See all Valsartan and Hydrochlorothiazide 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 and Hydrochlorothiazide NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Valsartan And Hydrochlorothiazide	Valsartan 160 mg/1; Hydrochlorothiazide 12.5 mg/1	Tablet, Film coatedOral	ScieGen Pharmaceuticals, INC.	50228-148	50228-0148-1050228-0148-30
Valsartan And Hydrochlorothiazide	Valsartan 80 mg/1; Hydrochlorothiazide 12.5 mg/1	Tablet, Film coatedOral	ScieGen Pharmaceuticals, INC.	50228-147	50228-0147-1050228-0147-30
Valsartan And Hydrochlorothiazide	Valsartan 320 mg/1; Hydrochlorothiazide 25 mg/1	Tablet, Film coatedOral	ScieGen Pharmaceuticals, INC.	50228-151	50228-0151-0550228-0151-30
Valsartan And Hydrochlorothiazide	Valsartan 160 mg/1; Hydrochlorothiazide 25 mg/1	Tablet, Film coatedOral	ScieGen Pharmaceuticals, INC.	50228-149	50228-0149-1050228-0149-30
Valsartan And Hydrochlorothiazide	Valsartan 320 mg/1; Hydrochlorothiazide 12.5 mg/1	Tablet, Film coatedOral	ScieGen Pharmaceuticals, INC.	50228-150	50228-0150-0550228-0150-30
Valsartan And Hydrochlorothiazide	Valsartan 160 mg/1; Hydrochlorothiazide 12.5 mg/1	Tablet, Film coatedOral	Golden State Medical Supply, Inc.	84677-073	84677-0073-90
Valsartan And Hydrochlorothiazide	Valsartan 80 mg/1; Hydrochlorothiazide 12.5 mg/1	Tablet, Film coatedOral	Golden State Medical Supply, Inc.	84677-072	84677-0072-90
Valsartan And Hydrochlorothiazide	Valsartan 320 mg/1; Hydrochlorothiazide 25 mg/1	Tablet, Film coatedOral	Golden State Medical Supply, Inc.	84677-076	84677-0076-90
Valsartan And Hydrochlorothiazide	Valsartan 160 mg/1; Hydrochlorothiazide 25 mg/1	Tablet, Film coatedOral	Golden State Medical Supply, Inc.	84677-074	84677-0074-90
Valsartan And Hydrochlorothiazide	Valsartan 320 mg/1; Hydrochlorothiazide 12.5 mg/1	Tablet, Film coatedOral	Golden State Medical Supply, Inc.	84677-075	84677-0075-90

All 99 Valsartan and Hydrochlorothiazide NDCs

Other NDCs under ANDA 204382

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

FDA NDC Directory listings under ANDA 204382
Product	Strength	Form · route	Labeler	Product NDC
Valsartan and Hydrochlorothiazide	Valsartan 80 mg/1; Hydrochlorothiazide 12.5 mg/1	Tablet, Film coatedOral	AvKARE	42291-965
Valsartan and Hydrochlorothiazide	Valsartan 160 mg/1; Hydrochlorothiazide 12.5 mg/1	Tablet, Film coatedOral	AvKARE	42291-966
Valsartan and Hydrochlorothiazide	Valsartan 160 mg/1; Hydrochlorothiazide 25 mg/1	Tablet, Film coatedOral	AvKARE	42291-967
Valsartan and Hydrochlorothiazide	Valsartan 320 mg/1; Hydrochlorothiazide 12.5 mg/1	Tablet, Film coatedOral	AvKARE	42291-968
Valsartan and Hydrochlorothiazide	Valsartan 320 mg/1; Hydrochlorothiazide 25 mg/1	Tablet, Film coatedOral	AvKARE	42291-969
Valsartan and Hydrochlorothiazide	Valsartan 160 mg/1; Hydrochlorothiazide 12.5 mg/1	Tablet, Film coatedOral	Amneal Pharmaceuticals of New York LLC	53746-846
Valsartan and Hydrochlorothiazide	Valsartan 160 mg/1; Hydrochlorothiazide 25 mg/1	Tablet, Film coatedOral	Amneal Pharmaceuticals of New York LLC	53746-847
Valsartan and Hydrochlorothiazide	Valsartan 320 mg/1; Hydrochlorothiazide 12.5 mg/1	Tablet, Film coatedOral	Amneal Pharmaceuticals of New York LLC	53746-848
Valsartan and Hydrochlorothiazide	Valsartan 320 mg/1; Hydrochlorothiazide 25 mg/1	Tablet, Film coatedOral	Amneal Pharmaceuticals of New York LLC	53746-849
Valsartan and Hydrochlorothiazide	Valsartan 80 mg/1; Hydrochlorothiazide 12.5 mg/1	Tablet, Film coatedOral	Amneal Pharmaceuticals LLC	65162-845
Valsartan and Hydrochlorothiazide	Valsartan 160 mg/1; Hydrochlorothiazide 12.5 mg/1	Tablet, Film coatedOral	Amneal Pharmaceuticals LLC	65162-846
Valsartan and Hydrochlorothiazide	Valsartan 160 mg/1; Hydrochlorothiazide 25 mg/1	Tablet, Film coatedOral	Amneal Pharmaceuticals LLC	65162-847
Valsartan and Hydrochlorothiazide	Valsartan 320 mg/1; Hydrochlorothiazide 12.5 mg/1	Tablet, Film coatedOral	Amneal Pharmaceuticals LLC	65162-848
Valsartan and Hydrochlorothiazide	Valsartan 320 mg/1; Hydrochlorothiazide 25 mg/1	Tablet, Film coatedOral	Amneal Pharmaceuticals LLC	65162-849