NDC codes

FDA NDC Directory
Product NDC (as listed)50090-5985Labeler and product segments. Claims need a package NDC.
Product NDC at billing width50090-5985Add 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
50090-5985-0500905985005009059850090 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50090-5985-0)Marketed from May 27, 2022

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
A-S Medication SolutionsNDC labeler code 50090
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 50090-5985_67e8d1ee-ea2c-48ad-911f-696692652d2eSPL ID 67e8d1ee-ea2c-48ad-911f-696692652d2eSPL set ID 1b72ecfd-a08d-48c5-a853-d3bc9ff882f1RxCUI 349353UNII 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

N450090598500 followed by a unit qualifier and the quantity

Package 50090-5985-00. 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 50090-5985

What is NDC 50090-5985?
50090-5985 is the product NDC for Valsartan and Hydrochlorothiazide, Valsartan 160 mg/1; Hydrochlorothiazide 25 mg/1 tablet, film coated, listed with the FDA by A-S Medication Solutions. 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?
A-S Medication Solutions, NDC labeler code 50090. 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 320 mg/1; Hydrochlorothiazide 25 mg/1Tablet, Film coatedOralNorthwind Health Company, LLC51655-243
Valsartan and HydrochlorothiazideValsartan 160 mg/1; Hydrochlorothiazide 12.5 mg/1Tablet, Film coatedOralNorthwind Health Company, LLC51655-389

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