Hydroxyzine Hydrochloride NDC 71335-0246

NDC codes

FDA NDC Directory

Product NDC (as listed)71335-0246Labeler and product segments. Claims need a package NDC.

Product NDC at billing width71335-0246Add 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
71335-0246-1	71335024601	120 TABLET, FILM COATED in 1 BOTTLE (71335-0246-1)Marketed from Oct 4, 2017
71335-0246-2	71335024602	20 TABLET, FILM COATED in 1 BOTTLE (71335-0246-2)Marketed from Oct 4, 2017
71335-0246-3	71335024603	30 TABLET, FILM COATED in 1 BOTTLE (71335-0246-3)Marketed from Oct 4, 2017
71335-0246-4	71335024604	60 TABLET, FILM COATED in 1 BOTTLE (71335-0246-4)Marketed from Oct 4, 2017
71335-0246-5	71335024605	90 TABLET, FILM COATED in 1 BOTTLE (71335-0246-5)Marketed from Oct 4, 2017

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 Hydrochloride
Generic name (nonproprietary): hydroxyzine hydrochloride
Active ingredients: Hydroxyzine dihydrochloride — 50 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Bryant Ranch Prepack
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 088619
Marketing start: Oct 22, 2012
Listing expires: Dec 31, 2026
Other FDA classes: Histamine Receptor Antagonists (Mechanism)
Identifiers: Product ID 71335-0246_8a3da07e-0bfc-4d10-9dd9-11a19486fff7SPL ID 8a3da07e-0bfc-4d10-9dd9-11a19486fff7SPL set ID 93d117dd-e2bf-4daa-abe3-d4fefed3313cRxCUI 995218, 995258, 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

N471335024601 followed by a unit qualifier and the quantity

Package 71335-0246-01. 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 Sep 11, 2025.

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 i…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

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
Product	Strength	Form · route	Labeler	Product NDC
Hydroxyzine Hydrochloride	Hydroxyzine dihydrochloride 50 mg/1	Tablet, Film coatedOral	PD-Rx Pharmaceuticals, Inc.	72789-269
Hydroxyzine HCL	Hydroxyzine dihydrochloride 50 mg/1	Tablet, Film coatedOral	Advanced Rx Pharmacy of Tennessee, LLC	80425-0173
Hydroxyzine Hydrochloride	Hydroxyzine dihydrochloride 50 mg/1	Tablet, Film coatedOral	Proficient Rx LP	71205-083
Hydroxyzine Hydrochloride	Hydroxyzine dihydrochloride 50 mg/1	Tablet, Film coatedOral	Teva Pharmaceuticals USA, Inc.	0093-5062
Hydroxyzine Hydrochloride	Hydroxyzine dihydrochloride 50 mg/1	Tablet, Film coatedOral	Northwind Health Company, LLC	51655-467