What is NDC 0404-9878?

0404-9878 is the product NDC for Hydroxyzine, Hydroxyzine dihydrochloride 50 mg/mL injection, solution, listed with the FDA by Henry Schein, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

Henry Schein, Inc., NDC labeler code 0404. 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?

None: this is the only finished product listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Hydroxyzine NDC 0404-9878 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)0404-9878Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00404-9878Add 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
0404-9878-02	0040498780200404987802	1 VIAL, SINGLE-DOSE in 1 BAG (0404-9878-02) / 2 mL in 1 VIAL, SINGLE-DOSEMarketed from Jan 17, 2022

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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
Generic name (nonproprietary): hydroxyzine
Active ingredients: Hydroxyzine dihydrochloride — 50 mg/mL
Dosage form: Injection, Solution
Route: Intramuscular
Labeler: Henry Schein, Inc.NDC labeler code 0404
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 087408
Marketing start: Jan 17, 2022
Listing expires: Dec 31, 2026
Other FDA classes: Histamine Receptor Antagonists (Mechanism)
Identifiers: Product ID 0404-9878_5d9b6c38-5a58-4278-999a-f430f34aafd4SPL ID 5d9b6c38-5a58-4278-999a-f430f34aafd4SPL set ID 851e7439-bb0a-4a09-9279-e3c33bff8965RxCUI 1794552UNII 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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.

Administration

Drug administration (CPT 96360–96549)

When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.

How CPT relates to drug billing

NDC on a medical claim

N400404987802 followed by a unit qualifier and the quantity

Package 00404-9878-02. 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 31, 2025.

Indications (excerpt from the label)

Indications and Usage The total management of anxiety, tension, and psychomotor agitation in conditions of emotional stress requires in most instances a combined approach of psychotherapy and chemotherapy. Hydroxyzine has been found to be particularly useful for this latter phase of therapy in its ability to render the disturbed patient more amenable to psychotherapy in long term treatment of the psychoneurotic and psychotic, although it should not be used as the sole treatment of psychosis or of clearly demonstrated cases of depression. Hydroxyzine is also useful in alleviating the manifestations of anxiety and tension as in the preparation for dental procedures and in acute emotional probl…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0404-9878

What is NDC 0404-9878?: 0404-9878 is the product NDC for Hydroxyzine, Hydroxyzine dihydrochloride 50 mg/mL injection, solution, listed with the FDA by Henry Schein, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Hydroxyzine.
What is the active ingredient?: Hydroxyzine dihydrochloride.
Who is the labeler?: Henry Schein, Inc., NDC labeler code 0404. 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?: None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other NDCs under ANDA 087408

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

FDA NDC Directory listings under ANDA 087408
Product	Strength	Form · route	Labeler	Product NDC
Hydroxyzine Hydrochloride	Hydroxyzine dihydrochloride 50 mg/mL	Injection, SolutionIntramuscular	Henry Schein, Inc.	0404-9877
Hydroxyzine Hydrochloride	Hydroxyzine dihydrochloride 25 mg/mL	Injection, SolutionIntramuscular	American Regent, Inc.	0517-4201
Hydroxyzine Hydrochloride	Hydroxyzine dihydrochloride 50 mg/mL	Injection, SolutionIntramuscular	American Regent, Inc.	0517-5601
Hydroxyzine Hydrochloride	Hydroxyzine dihydrochloride 50 mg/mL	Injection, SolutionIntramuscular	American Regent, Inc.	0517-5602
Hydroxyzine Hydrochloride	Hydroxyzine dihydrochloride 25 mg/mL	Injection, SolutionIntramuscular	HF Acquisition Co LLC, DBA HealthFirst	51662-1649