Hydroxyzine Hydrochloride NDC 31722-500

NDC codes

FDA NDC Directory

Product NDC (as listed)31722-500Labeler and product segments. Claims need a package NDC.

Product NDC at billing width31722-0500Add 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
31722-500-01	31722050001	100 TABLET, FILM COATED in 1 BOTTLE (31722-500-01)Marketed from May 29, 2008
31722-500-05	31722050005	500 TABLET, FILM COATED in 1 BOTTLE (31722-500-05)Marketed from May 29, 2008
31722-500-10	31722050010	1000 TABLET, FILM COATED in 1 BOTTLE (31722-500-10)Marketed from May 29, 2008

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/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Camber Pharmaceuticals, Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 040805
Marketing start: May 29, 2008
Listing expires: Dec 31, 2026
Other FDA classes: Histamine Receptor Antagonists (Mechanism)
Identifiers: Product ID 31722-500_ee32d5bd-38fb-4a93-e053-2a95a90a0464SPL ID ee32d5bd-38fb-4a93-e053-2a95a90a0464SPL set ID f7e527fe-2f67-45ad-a3ec-146ead819514RxCUI 995218, 995258, 995281UNII 76755771U3UPC 0331722502016, 0331722501019, 0331722500012
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

N431722050001 followed by a unit qualifier and the quantity

Package 31722-0500-01. 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 Nov 24, 2022.

Indications (excerpt from the label)

INDICATIONS & 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 a…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 040805

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

FDA NDC Directory listings under ANDA 040805
Product	Strength	Form · route	Labeler	Product NDC
Hydroxyzine Hydrochloride	Hydroxyzine dihydrochloride 50 mg/1	Tablet, Film coatedOral	Camber Pharmaceuticals, Inc.	31722-502
Hydroxyzine Hydrochloride	Hydroxyzine dihydrochloride 25 mg/1	Tablet, Film coatedOral	Camber Pharmaceuticals, Inc.	31722-501