Hydroxyzine Hydrochloride NDC 54838-502

NDC codes

FDA NDC Directory

Product NDC (as listed)54838-502Labeler and product segments. Claims need a package NDC.

Product NDC at billing width54838-0502Add 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	Copy
54838-502-80	54838050280	473 mL in 1 BOTTLE, PLASTIC (54838-502-80)Marketed from Aug 21, 2013

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): Hydroxyzine Hydrochloride
Generic name (nonproprietary): hydroxyzine hydrochloride
Active ingredients: Hydroxyzine dihydrochloride — 10 mg/5mL
Dosage form: Solution
Route: Oral
Labeler: Lannett Company, Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 201674
Marketing start: Aug 21, 2013
Listing expires: Dec 31, 2026
Other FDA classes: Histamine Receptor Antagonists (Mechanism)
Identifiers: Product ID 54838-502_823645dc-4e60-4279-97fa-ca0d1c1d7ad8SPL ID 823645dc-4e60-4279-97fa-ca0d1c1d7ad8SPL set ID a4fb61ae-aad6-4bd6-83fc-8b227f175df9RxCUI 995241UNII 76755771U3UPC 0354838502800
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

N454838050280 followed by a unit qualifier and the quantity

Package 54838-0502-80. 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

Label details couldn’t be retrieved right now. Open the label on DailyMed.

Other NDCs under ANDA 201674

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

FDA NDC Directory listings under ANDA 201674
Product	Strength	Form · route	Labeler	Product NDC
Hydroxyzine Hydrochloride	Hydroxyzine dihydrochloride 10 mg/5mL	SolutionOral	Chartwell RX, LLC	62135-502
Hydroxyzine Hydrochloride	Hydroxyzine dihydrochloride 10 mg/5mL	SolutionOral	ATLANTIC BIOLOGICALS CORP.	17856-0507