Valsartan and Hydrochlorothiazide NDC 65162-847

NDC codes

FDA NDC Directory

Product NDC (as listed)65162-847Labeler and product segments. Claims need a package NDC.

Product NDC at billing width65162-0847Add 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
65162-847-03	65162084703	30 TABLET, FILM COATED in 1 BOTTLE (65162-847-03)Marketed from Aug 14, 2023
65162-847-09	65162084709	90 TABLET, FILM COATED in 1 BOTTLE (65162-847-09)Marketed from Aug 14, 2023
65162-847-11	65162084711	1000 TABLET, FILM COATED in 1 BOTTLE (65162-847-11)Marketed from Aug 14, 2023
65162-847-50	65162084750	500 TABLET, FILM COATED in 1 BOTTLE (65162-847-50)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 — 160 mg/1Hydrochlorothiazide — 25 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Amneal Pharmaceuticals LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 204382
Marketing start: Aug 14, 2023
Listing expires: Dec 31, 2026
Other FDA classes: Angiotensin 2 Receptor Antagonists (Mechanism)Increased Diuresis (Physiologic effect)Thiazides (Chemical structure)
Identifiers: Product ID 65162-847_e40f4475-c8d3-48a6-913f-cf7c8c7b119bSPL ID e40f4475-c8d3-48a6-913f-cf7c8c7b119bSPL set ID c9acbc95-3629-4276-842b-5c074844dba7RxCUI 200284, 200285, 349353, 636042, 636045UNII 80M03YXJ7I, 0J48LPH2THUPC 0365162849097, 0365162847093, 0365162846096, 0365162848090
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

N465162084703 followed by a unit qualifier and the quantity

Package 65162-0847-03. 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 Feb 2, 2019. 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 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, including, as appropriate, lipid contr…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

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 160 mg/1; Hydrochlorothiazide 25 mg/1	Tablet, Film coatedOral	Amneal Pharmaceuticals of New York LLC	53746-847
Valsartan and Hydrochlorothiazide	Valsartan 80 mg/1; Hydrochlorothiazide 12.5 mg/1	Tablet, Film coatedOral	Amneal Pharmaceuticals of New York LLC	53746-845
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 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	AvKARE	42291-965
Valsartan and Hydrochlorothiazide	Valsartan 320 mg/1; Hydrochlorothiazide 12.5 mg/1	Tablet, Film coatedOral	AvKARE	42291-968
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 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 LLC	65162-846
Valsartan and Hydrochlorothiazide	Valsartan 80 mg/1; Hydrochlorothiazide 12.5 mg/1	Tablet, Film coatedOral	Amneal Pharmaceuticals LLC	65162-845
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