NDC codes

FDA NDC Directory
Product NDC (as listed)51655-389Labeler and product segments. Claims need a package NDC.
Product NDC at billing width51655-0389Add 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
51655-389-52516550389525165503895230 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-389-52)Marketed from Mar 29, 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 — 12.5 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Labeler
Northwind Health Company, LLCNDC labeler code 51655
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 078020
Marketing start
Listing expires
Other FDA classes
Angiotensin 2 Receptor Antagonists (Mechanism)Increased Diuresis (Physiologic effect)Thiazides (Chemical structure)
Identifiers
Product ID 51655-389_48fedb0d-d803-7788-e063-6294a90a03e0SPL ID 48fedb0d-d803-7788-e063-6294a90a03e0SPL set ID f835fa93-6529-c06d-e053-6394a90ad42aRxCUI 200285UNII 80M03YXJ7I, 0J48LPH2TH
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

N451655038952 followed by a unit qualifier and the quantity

Package 51655-0389-52. 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 51655-389

What is NDC 51655-389?
51655-389 is the product NDC for Valsartan and Hydrochlorothiazide, Valsartan 160 mg/1; Hydrochlorothiazide 12.5 mg/1 tablet, film coated, listed with the FDA by Northwind Health Company, 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?
Northwind Health Company, LLC, NDC labeler code 51655. 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 078020

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

FDA NDC Directory listings under ANDA 078020
ProductStrengthForm · routeLabelerProduct NDC
Valsartan and HydrochlorothiazideValsartan 80 mg/1; Hydrochlorothiazide 12.5 mg/1Tablet, Film coatedOralMylan Pharmaceuticals Inc.0378-6321
Valsartan and HydrochlorothiazideValsartan 160 mg/1; Hydrochlorothiazide 12.5 mg/1Tablet, Film coatedOralMylan Pharmaceuticals Inc.0378-6322
Valsartan and HydrochlorothiazideValsartan 160 mg/1; Hydrochlorothiazide 25 mg/1Tablet, Film coatedOralMylan Pharmaceuticals Inc.0378-6323
Valsartan and HydrochlorothiazideValsartan 320 mg/1; Hydrochlorothiazide 12.5 mg/1Tablet, Film coatedOralMylan Pharmaceuticals Inc.0378-6324
Valsartan and HydrochlorothiazideValsartan 320 mg/1; Hydrochlorothiazide 25 mg/1Tablet, Film coatedOralMylan Pharmaceuticals Inc.0378-6325
Valsartan and HydrochlorothiazideValsartan 160 mg/1; Hydrochlorothiazide 25 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-5985
Valsartan and HydrochlorothiazideValsartan 320 mg/1; Hydrochlorothiazide 25 mg/1Tablet, Film coatedOralNorthwind Health Company, LLC51655-243

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