Hydroxyzine Hydrochloride NDC 81033-031

NDC codes

FDA NDC Directory

Product NDC (as listed)81033-031Labeler and product segments. Claims need a package NDC.

Product NDC at billing width81033-0031Add 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
81033-031-44	81033003144	40 CUP, UNIT-DOSE in 1 CARTON (81033-031-44) / 5 mL in 1 CUP, UNIT-DOSE (81033-031-05)Marketed from Feb 27, 2026
81033-031-45	81033003145	40 CUP, UNIT-DOSE in 1 CARTON (81033-031-45) / 12.5 mL in 1 CUP, UNIT-DOSE (81033-031-12)Marketed from Feb 27, 2026

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: Kesin Pharma
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 219289
Marketing start: Jul 17, 2025
Listing expires: Dec 31, 2027
Other FDA classes: Histamine Receptor Antagonists (Mechanism)
Identifiers: Product ID 81033-031_4cac7248-0970-077a-e063-6294a90a782dSPL ID 4cac7248-0970-077a-e063-6294a90a782dSPL set ID 4b094d1b-97b2-6ca6-e063-6294a90a2437RxCUI 995241UNII 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

N481033003144 followed by a unit qualifier and the quantity

Package 81033-0031-44. 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 Mar 10, 2026.

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 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)

Other NDCs under ANDA 219289

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

FDA NDC Directory listings under ANDA 219289
Product	Strength	Form · route	Labeler	Product NDC
Hydroxyzine Hydrochloridehydroxyzine hydrochloride oral	Hydroxyzine dihydrochloride 10 mg/5mL	SolutionOral	Bionpharma Inc.	69452-395