Valsartan and Hydrochlorothiazide NDC 46708-453

NDC codes

FDA NDC Directory

Product NDC (as listed)46708-453Labeler and product segments. Claims need a package NDC.

Product NDC at billing width46708-0453Add 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
46708-453-10	46708045310	100 TABLET, FILM COATED in 1 CARTON (46708-453-10)Marketed from May 20, 2016
46708-453-30	46708045330	30 TABLET, FILM COATED in 1 BOTTLE (46708-453-30)Marketed from May 20, 2016
46708-453-71	46708045371	500 TABLET, FILM COATED in 1 BOTTLE (46708-453-71)Marketed from May 20, 2016
46708-453-90	46708045390	90 TABLET, FILM COATED in 1 BOTTLE (46708-453-90)Marketed from May 20, 2016

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: Alembic Pharmaceuticals Limited
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 201662
Marketing start: May 20, 2016
Listing expires: Dec 31, 2026
Other FDA classes: Angiotensin 2 Receptor Antagonists (Mechanism)Increased Diuresis (Physiologic effect)Thiazides (Chemical structure)
Identifiers: Product ID 46708-453_7fb28413-d2ab-4534-8f12-48ce33bbc6a9SPL ID 7fb28413-d2ab-4534-8f12-48ce33bbc6a9SPL set ID 3b80f726-9e1e-4d44-ad4f-afd10e26292fRxCUI 200284, 200285, 349353, 636042, 636045UNII 80M03YXJ7I, 0J48LPH2THUPC 0346708454302, 0346708455309, 0346708456306, 0346708457303, 0346708453305
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

N446708045310 followed by a unit qualifier and the quantity

Package 46708-0453-10. 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 Jan 27, 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 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 201662

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

FDA NDC Directory listings under ANDA 201662
Product	Strength	Form · route	Labeler	Product NDC
Valsartan and Hydrochlorothiazide	Valsartan 320 mg/1; Hydrochlorothiazide 25 mg/1	Tablet, Film coatedOral	Proficient Rx LP	71205-015
Valsartan and Hydrochlorothiazide	Valsartan 80 mg/1; Hydrochlorothiazide 12.5 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-3292
Valsartan and Hydrochlorothiazide	Valsartan 160 mg/1; Hydrochlorothiazide 25 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-4872
Valsartan and Hydrochlorothiazide	Valsartan 320 mg/1; Hydrochlorothiazide 12.5 mg/1	Tablet, Film coatedOral	Proficient Rx LP	71205-042
Valsartan and Hydrochlorothiazide	Valsartan 320 mg/1; Hydrochlorothiazide 25 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	71335-0853
Valsartan and Hydrochlorothiazide	Valsartan 320 mg/1; Hydrochlorothiazide 12.5 mg/1	Tablet, Film coatedOral	Alembic Pharmaceuticals Limited	46708-456
Valsartan and Hydrochlorothiazide	Valsartan 160 mg/1; Hydrochlorothiazide 12.5 mg/1	Tablet, Film coatedOral	Alembic Pharmaceuticals Limited	46708-454
Valsartan and Hydrochlorothiazide	Valsartan 160 mg/1; Hydrochlorothiazide 25 mg/1	Tablet, Film coatedOral	Alembic Pharmaceuticals Limited	46708-455
Valsartan and Hydrochlorothiazide	Valsartan 320 mg/1; Hydrochlorothiazide 25 mg/1	Tablet, Film coatedOral	Alembic Pharmaceuticals Limited	46708-457
Valsartan and Hydrochlorothiazide	Valsartan 80 mg/1; Hydrochlorothiazide 12.5 mg/1	Tablet, Film coatedOral	Alembic Pharmaceuticals Inc.	62332-079
Valsartan and Hydrochlorothiazide	Valsartan 80 mg/1; Hydrochlorothiazide 12.5 mg/1	Tablet, Film coatedOral	Proficient Rx LP	63187-943
Valsartan and Hydrochlorothiazide	Valsartan 320 mg/1; Hydrochlorothiazide 25 mg/1	Tablet, Film coatedOral	Alembic Pharmaceuticals Inc.	62332-083
Valsartan and Hydrochlorothiazide	Valsartan 160 mg/1; Hydrochlorothiazide 12.5 mg/1	Tablet, Film coatedOral	Alembic Pharmaceuticals Inc.	62332-080
Valsartan and Hydrochlorothiazide	Valsartan 160 mg/1; Hydrochlorothiazide 25 mg/1	Tablet, Film coatedOral	Alembic Pharmaceuticals Inc.	62332-081
Valsartan and Hydrochlorothiazide	Valsartan 320 mg/1; Hydrochlorothiazide 12.5 mg/1	Tablet, Film coatedOral	Alembic Pharmaceuticals Inc.	62332-082