Prescription drug · ANDA
Hydroxyzine HCL NDC 80425-0173
Hydroxyzine dihydrochloride 50 mg/1 · Tablet, Film coated · Oral · Advanced Rx Pharmacy of Tennessee, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 80425-0173-1 | 80425017301 | 30 TABLET, FILM COATED in 1 BOTTLE (80425-0173-1)Marketed from Feb 19, 2013 | |
| 80425-0173-2 | 80425017302 | 60 TABLET, FILM COATED in 1 BOTTLE (80425-0173-2)Marketed from Apr 25, 2024 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 HCL
- Generic name (nonproprietary)
- hydroxyzine hcl
- Active ingredients
- Hydroxyzine dihydrochloride — 50 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 088619
- Marketing start
- Listing expires
- Other FDA classes
- Histamine Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 80425-0173_16edd342-ced2-eeb7-e063-6394a90a35efSPL ID 16edd342-ced2-eeb7-e063-6394a90a35efSPL set ID cd4ea0ea-0d92-b70c-e053-2995a90a62ceRxCUI 995281UNII 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
N480425017301followed by a unit qualifier and the quantityPackage 80425-0173-01. 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 .
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 in…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 088619
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/1 | Tablet, Film coatedOral | PD-Rx Pharmaceuticals, Inc. | 72789-269 |
| Hydroxyzine Hydrochloride | Hydroxyzine dihydrochloride 50 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 71205-083 |
| Hydroxyzine Hydrochloride | Hydroxyzine dihydrochloride 50 mg/1 | Tablet, Film coatedOral | Teva Pharmaceuticals USA, Inc. | 0093-5062 |
| Hydroxyzine Hydrochloride | Hydroxyzine dihydrochloride 50 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-0246 |
| Hydroxyzine Hydrochloride | Hydroxyzine dihydrochloride 50 mg/1 | Tablet, Film coatedOral | Northwind Health Company, LLC | 51655-467 |