Prescription drug · ANDA
Hydroxyzine Hydrochloride NDC 0517-4201
Hydroxyzine dihydrochloride 25 mg/mL · Injection, Solution · Intramuscular · American Regent, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0517-4201-25 | 00517420125 | 25 VIAL, SINGLE-DOSE in 1 TRAY (0517-4201-25) / 1 mL in 1 VIAL, SINGLE-DOSE (0517-4201-01)Marketed from Sep 30, 1990 |
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 Hydrochloride
- Generic name (nonproprietary)
- hydroxyzine hydrochloride
- Active ingredients
- Hydroxyzine dihydrochloride — 25 mg/mL
- Dosage form
- Injection, Solution
- Route
- Intramuscular
- Labeler
- American Regent, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 087408
- Marketing start
- Listing expires
- Other FDA classes
- Histamine Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 0517-4201_83de333d-1bf1-4168-8614-6bc79c26d5d0SPL ID 83de333d-1bf1-4168-8614-6bc79c26d5d0SPL set ID 8af7e5ce-d9d9-44cc-9f2f-4ddbc89e758aRxCUI 995270, 995285, 1794552, 1794554UNII 76755771U3UPC 0305174201254, 0305175601251, 0305175602258
- 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.
- NDC on a medical claim
N400517420125followed by a unit qualifier and the quantityPackage 00517-4201-25. 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 .
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.
Other NDCs under ANDA 087408
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Hydroxyzine Hydrochloride | Hydroxyzine dihydrochloride 50 mg/mL | Injection, SolutionIntramuscular | Henry Schein, Inc. | 0404-9877 |
| Hydroxyzine | Hydroxyzine dihydrochloride 50 mg/mL | Injection, SolutionIntramuscular | Henry Schein, Inc. | 0404-9878 |
| 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 |