NDC codes

FDA NDC Directory
Product NDC (as listed)43547-314Labeler and product segments. Claims need a package NDC.
Product NDC at billing width43547-0314Add 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 NDC11-digit (billing)PackageCopy
43547-314-03435470314034354703140330 TABLET, FILM COATED in 1 BOTTLE (43547-314-03)Marketed from Dec 3, 2021
43547-314-09435470314094354703140990 TABLET, FILM COATED in 1 BOTTLE (43547-314-09)Marketed from Dec 3, 2021
43547-314-504354703145043547031450500 TABLET, FILM COATED in 1 BOTTLE (43547-314-50)Marketed from Dec 3, 2021

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 — 320 mg/1Hydrochlorothiazide — 12.5 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Labeler
Solco Healthcare US, LLCNDC labeler code 43547
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 206083
Marketing start
Listing expires
Other FDA classes
Angiotensin 2 Receptor Antagonists (Mechanism)Increased Diuresis (Physiologic effect)Thiazides (Chemical structure)
Identifiers
Product ID 43547-314_2d03a607-2ffd-4df1-8c94-bec2b786709cSPL ID 2d03a607-2ffd-4df1-8c94-bec2b786709cSPL set ID f8b0a8ab-4549-4553-a127-bf2c0291a4b1RxCUI 200284, 200285, 349353, 636042, 636045UNII 80M03YXJ7I, 0J48LPH2THUPC 0343547315092, 0343547314095, 0343547313036, 0343547315030, 0343547312091, 0343547311032, 0343547314033, 0343547312039, 0343547311094, 0343547313098
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

N443547031403 followed by a unit qualifier and the quantity

Package 43547-0314-03. 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 . 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 43547-314

What is NDC 43547-314?
43547-314 is the product NDC for Valsartan And Hydrochlorothiazide, Valsartan 320 mg/1; Hydrochlorothiazide 12.5 mg/1 tablet, film coated, listed with the FDA by Solco Healthcare US, LLC. It has 3 package NDCs, 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?
Solco Healthcare US, LLC, NDC labeler code 43547. 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
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Valsartan And HydrochlorothiazideValsartan 160 mg/1; Hydrochlorothiazide 12.5 mg/1Tablet, Film coatedOralScieGen Pharmaceuticals, INC.50228-14850228-0148-1050228-0148-30
Valsartan And HydrochlorothiazideValsartan 80 mg/1; Hydrochlorothiazide 12.5 mg/1Tablet, Film coatedOralScieGen Pharmaceuticals, INC.50228-14750228-0147-1050228-0147-30
Valsartan And HydrochlorothiazideValsartan 320 mg/1; Hydrochlorothiazide 25 mg/1Tablet, Film coatedOralScieGen Pharmaceuticals, INC.50228-15150228-0151-0550228-0151-30
Valsartan And HydrochlorothiazideValsartan 160 mg/1; Hydrochlorothiazide 25 mg/1Tablet, Film coatedOralScieGen Pharmaceuticals, INC.50228-14950228-0149-1050228-0149-30
Valsartan And HydrochlorothiazideValsartan 320 mg/1; Hydrochlorothiazide 12.5 mg/1Tablet, Film coatedOralScieGen Pharmaceuticals, INC.50228-15050228-0150-0550228-0150-30
Valsartan And HydrochlorothiazideValsartan 160 mg/1; Hydrochlorothiazide 12.5 mg/1Tablet, Film coatedOralGolden State Medical Supply, Inc.84677-07384677-0073-90
Valsartan And HydrochlorothiazideValsartan 80 mg/1; Hydrochlorothiazide 12.5 mg/1Tablet, Film coatedOralGolden State Medical Supply, Inc.84677-07284677-0072-90
Valsartan And HydrochlorothiazideValsartan 320 mg/1; Hydrochlorothiazide 25 mg/1Tablet, Film coatedOralGolden State Medical Supply, Inc.84677-07684677-0076-90
Valsartan And HydrochlorothiazideValsartan 160 mg/1; Hydrochlorothiazide 25 mg/1Tablet, Film coatedOralGolden State Medical Supply, Inc.84677-07484677-0074-90
Valsartan And HydrochlorothiazideValsartan 320 mg/1; Hydrochlorothiazide 12.5 mg/1Tablet, Film coatedOralGolden State Medical Supply, Inc.84677-07584677-0075-90

All 99 Valsartan And Hydrochlorothiazide NDCs

Other NDCs under ANDA 206083

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

FDA NDC Directory listings under ANDA 206083
ProductStrengthForm · routeLabelerProduct NDC
Valsartan And HydrochlorothiazideValsartan 80 mg/1; Hydrochlorothiazide 12.5 mg/1Tablet, Film coatedOralSolco Healthcare US, LLC43547-311
Valsartan And HydrochlorothiazideValsartan 160 mg/1; Hydrochlorothiazide 12.5 mg/1Tablet, Film coatedOralSolco Healthcare US, LLC43547-312
Valsartan And HydrochlorothiazideValsartan 160 mg/1; Hydrochlorothiazide 25 mg/1Tablet, Film coatedOralSolco Healthcare US, LLC43547-313
Valsartan And HydrochlorothiazideValsartan 320 mg/1; Hydrochlorothiazide 25 mg/1Tablet, Film coatedOralSolco Healthcare US, LLC43547-315
Valsartan And HydrochlorothiazideValsartan 160 mg/1; Hydrochlorothiazide 12.5 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-6232
Valsartan And HydrochlorothiazideValsartan 320 mg/1; Hydrochlorothiazide 12.5 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-7442
Valsartan And HydrochlorothiazideValsartan 320 mg/1; Hydrochlorothiazide 25 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-7443
Valsartan And HydrochlorothiazideValsartan 160 mg/1; Hydrochlorothiazide 25 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-7444
Valsartan And HydrochlorothiazideValsartan 160 mg/1; Hydrochlorothiazide 12.5 mg/1Tablet, Film coatedOralPreferred Pharmaceuticals Inc.68788-8463
Valsartan And HydrochlorothiazideValsartan 320 mg/1; Hydrochlorothiazide 25 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-2200
Valsartan And HydrochlorothiazideValsartan 160 mg/1; Hydrochlorothiazide 12.5 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-2617
Valsartan And HydrochlorothiazideValsartan 80 mg/1; Hydrochlorothiazide 12.5 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-2618
Valsartan And HydrochlorothiazideValsartan 160 mg/1; Hydrochlorothiazide 25 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-2633
Valsartan And HydrochlorothiazideValsartan 320 mg/1; Hydrochlorothiazide 12.5 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-3070

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