Hydroxyzine Hydrochloride NDC 62135-502

NDC codes

FDA NDC Directory

Product NDC (as listed)62135-502Labeler and product segments. Claims need a package NDC.

Product NDC at billing width62135-0502Add 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
62135-502-47	62135050247	473 mL in 1 BOTTLE (62135-502-47)Marketed from Oct 3, 2022

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: Chartwell RX, LLC
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 62135-502_0770c6f3-a76a-819c-e063-6294a90a3cd8SPL ID 0770c6f3-a76a-819c-e063-6294a90a3cd8SPL set ID 4590101d-7fb2-478b-acc5-bc9bdbb38ca9RxCUI 995241UNII 76755771U3UPC 0362135502478
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

N462135050247 followed by a unit qualifier and the quantity

Package 62135-0502-47. 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 Oct 11, 2023.

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 in premedication and following general anesthesia, Hydroxyzine may potentiate meperidine (Demerol ® ) 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 …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

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	Lannett Company, Inc.	54838-502
Hydroxyzine Hydrochloride	Hydroxyzine dihydrochloride 10 mg/5mL	SolutionOral	ATLANTIC BIOLOGICALS CORP.	17856-0507