NDC codes

FDA NDC Directory
Product NDC (as listed)80425-0173Labeler and product segments. Claims need a package NDC.
Product NDC at billing width80425-0173Add 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
80425-0173-1804250173018042501730130 TABLET, FILM COATED in 1 BOTTLE (80425-0173-1)Marketed from Feb 19, 2013
80425-0173-2804250173028042501730260 TABLET, FILM COATED in 1 BOTTLE (80425-0173-2)Marketed from Apr 25, 2024

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)
Hydroxyzine HCL
Generic name (nonproprietary)
hydroxyzine hcl
Active ingredients
Hydroxyzine dihydrochloride — 50 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Labeler
Advanced Rx Pharmacy of Tennessee, LLCNDC labeler code 80425
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 088619
Marketing start
Listing expires
Other FDA classes
Histamine Receptor Antagonists (Mechanism)
Identifiers
Product ID 80425-0173_16edd342-ced2-eeb7-e063-6394a90a35efSPL ID 16edd342-ced2-eeb7-e063-6394a90a35efSPL set ID cd4ea0ea-0d92-b70c-e053-2995a90a62ceRxCUI 995281UNII 76755771U3
Pharmacologic class
Antihistamine

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

N480425017301 followed by a unit qualifier and the quantity

Package 80425-0173-01. 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 .

Indications (excerpt from the label)

Indications and Usage For symptomatic relief of anxiety and tension associated with psychoneurosis and as an adjunct in organic disease states in which anxiety is manifested. Useful in the management of pruritus due to allergic conditions such as chronic urticaria and atopic and contact dermatoses and in histamine-mediated pruritus. As a sedative when used as a premedication and following general anesthesia, hydroxyzine may potentiate meperidine and barbiturates, so their use in pre-anesthetic adjunctive therapy should be modified on an individual basis. Atropine and other belladonna alkaloids are not affected by the drug. Hydroxyzine is not known to interfere with the action of digitalis in…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 80425-0173

What is NDC 80425-0173?
80425-0173 is the product NDC for Hydroxyzine HCL, Hydroxyzine dihydrochloride 50 mg/1 tablet, film coated, listed with the FDA by Advanced Rx Pharmacy of Tennessee, LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Hydroxyzine HCL.
What is the active ingredient?
Hydroxyzine dihydrochloride.
Who is the labeler?
Advanced Rx Pharmacy of Tennessee, LLC, NDC labeler code 80425. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Hydroxyzine HCL?
1 other product NDC are listed under this name. See all Hydroxyzine HCL 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 Hydroxyzine HCL NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Hydroxyzine HCLHydroxyzine dihydrochloride 50 mg/1Tablet, Film coatedOralDirect_rx72189-57772189-0577-60

Other NDCs under ANDA 088619

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

FDA NDC Directory listings under ANDA 088619
ProductStrengthForm · routeLabelerProduct NDC
Hydroxyzine HydrochlorideHydroxyzine dihydrochloride 50 mg/1Tablet, Film coatedOralTeva Pharmaceuticals USA, Inc.0093-5062
Hydroxyzine HydrochlorideHydroxyzine dihydrochloride 50 mg/1Tablet, Film coatedOralNorthwind Health Company, LLC51655-467
Hydroxyzine HydrochlorideHydroxyzine dihydrochloride 50 mg/1Tablet, Film coatedOralProficient Rx LP71205-083
Hydroxyzine HydrochlorideHydroxyzine dihydrochloride 50 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-0246
Hydroxyzine HydrochlorideHydroxyzine dihydrochloride 50 mg/1Tablet, Film coatedOralPD-Rx Pharmaceuticals, Inc.72789-269

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