What is NDC 11534-204?

11534-204 is the product NDC for Hydroxyzine Hydrochloride, Hydroxyzine dihydrochloride 10 mg/1 tablet, film coated, listed with the FDA by Sunrise Pharmaceutical, Inc.. It has 3 package NDCs, shown above in 10- and 11-digit form.

Sunrise Pharmaceutical, Inc., NDC labeler code 11534. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Hydroxyzine Hydrochloride?

194 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Hydroxyzine Hydrochloride NDC 11534-204

NDC codes

FDA NDC Directory

Product NDC (as listed)11534-204Labeler and product segments. Claims need a package NDC.

Product NDC at billing width11534-0204Add 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
11534-204-01	1153402040111534020401	100 TABLET, FILM COATED in 1 BOTTLE (11534-204-01)Marketed from Apr 16, 2024
11534-204-03	1153402040311534020403	1000 TABLET, FILM COATED in 1 BOTTLE (11534-204-03)Marketed from Apr 16, 2024
11534-204-04	1153402040411534020404	500 TABLET, FILM COATED in 1 BOTTLE (11534-204-04)Marketed from Jan 10, 2025

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: Sunrise Pharmaceutical, Inc.NDC labeler code 11534
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 207121
Marketing start: Apr 16, 2024
Listing expires: Dec 31, 2026
Other FDA classes: Histamine Receptor Antagonists (Mechanism)
Identifiers: Product ID 11534-204_4f0e9eea-4f47-49fe-a609-790dada173d0SPL ID 4f0e9eea-4f47-49fe-a609-790dada173d0SPL set ID 94561525-a565-4193-b64d-e1459ab05678RxCUI 995218, 995258, 995281UNII 76755771U3UPC 0311534204032, 0311534206036
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

N411534020401 followed by a unit qualifier and the quantity

Package 11534-0204-01. 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 Dec 9, 2024.

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)

About NDC 11534-204

What is NDC 11534-204?: 11534-204 is the product NDC for Hydroxyzine Hydrochloride, Hydroxyzine dihydrochloride 10 mg/1 tablet, film coated, listed with the FDA by Sunrise Pharmaceutical, Inc.. It has 3 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Hydroxyzine Hydrochloride.
What is the active ingredient?: Hydroxyzine dihydrochloride.
Who is the labeler?: Sunrise Pharmaceutical, Inc., NDC labeler code 11534. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Hydroxyzine Hydrochloride?: 194 other product NDCs are listed under this name. See all Hydroxyzine Hydrochloride NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Hydroxyzine Hydrochloride NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Hydroxyzine Hydrochloride	Hydroxyzine hydrochloride 10 mg/5mL	SolutionOral	Advagen Pharma Limited	72888-218	72888-0218-13
Hydroxyzine hydrochloride	Hydroxyzine hydrochloride 50 mg/1	TabletOral	Coupler LLC	67046-0566	67046-0566-03
Hydroxyzine hydrochloride	Hydroxyzine hydrochloride 10 mg/1	TabletOral	Coupler LLC	67046-0833	67046-0833-03
Hydroxyzine Hydrochloride	Hydroxyzine dihydrochloride 25 mg/1	Tablet, Film coatedOral	Advanced Rx of Tennessee, LLC	80425-0590	80425-0590-0180425-0590-0280425-0590-03
Hydroxyzine hydrochloride	Hydroxyzine hydrochloride 50 mg/1	TabletOral	Unit Dose Solutions, Inc.	87441-039	87441-0039-01
Hydroxyzine Hydrochloride	Hydroxyzine hydrochloride 10 mg/5mL	SolutionOral	Saptalis Pharmaceuticals, LLC.	71656-090	71656-0090-16
Hydroxyzine Hydrochloride	Hydroxyzine dihydrochloride 25 mg/1	Tablet, Film coatedOral	Coupler LLC	67046-1311	67046-1311-03
Hydroxyzine hydrochloride	Hydroxyzine dihydrochloride 25 mg/1	TabletOral	Coupler LLC	67046-0713	67046-0713-03
Hydroxyzine Hydrochloride	Hydroxyzine dihydrochloride 10 mg/5mL	SolutionOral	ANI Pharmaceuticals, Inc.	70954-912	70954-0912-10
Hydroxyzine Hydrochloride	Hydroxyzine hydrochloride 25 mg/1	Tablet, Film coatedOral	Cardinal Health 107, LLC	55154-2148	55154-2148-00

All 195 Hydroxyzine Hydrochloride NDCs

Other NDCs under ANDA 207121

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

FDA NDC Directory listings under ANDA 207121
Product	Strength	Form · route	Labeler	Product NDC
Hydroxyzine Hydrochloride	Hydroxyzine dihydrochloride 10 mg/1	Tablet, Film coatedOral	Marlex Pharmaceuticals, Inc.	10135-810
Hydroxyzine Hydrochloride	Hydroxyzine dihydrochloride 25 mg/1	Tablet, Film coatedOral	Marlex Pharmaceuticals, Inc.	10135-811
Hydroxyzine Hydrochloride	Hydroxyzine dihydrochloride 50 mg/1	Tablet, Film coatedOral	Marlex Pharmaceuticals, Inc.	10135-812
Hydroxyzine Hydrochloride	Hydroxyzine dihydrochloride 25 mg/1	Tablet, Film coatedOral	Sunrise Pharmaceutical, Inc.	11534-205
Hydroxyzine Hydrochloride	Hydroxyzine dihydrochloride 50 mg/1	Tablet, Film coatedOral	Sunrise Pharmaceutical, Inc.	11534-206