Prescription drug · ANDA
Hydroxyzine hydrochloride NDC 50090-6624
Hydroxyzine dihydrochloride 25 mg/1 · Tablet · Oral · A-S Medication Solutions
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50090-6624-0 | 50090662400 | 90 TABLET in 1 BOTTLE (50090-6624-0)Marketed from Aug 25, 2023 |
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 hydrochloride
- Generic name (nonproprietary)
- hydroxyzine hydrochloride
- Active ingredients
- Hydroxyzine dihydrochloride — 25 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- A-S Medication Solutions
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 204279
- Marketing start
- Listing expires
- Other FDA classes
- Histamine Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 50090-6624_48b45350-d5c4-4266-aed3-8dce028edde9SPL ID 48b45350-d5c4-4266-aed3-8dce028edde9SPL set ID 2e346b0c-9407-4346-82c2-d9755cbcd8b0RxCUI 995258UNII 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
N450090662400followed by a unit qualifier and the quantityPackage 50090-6624-00. 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 204279
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 25 mg/1 | TabletOral | Medsource Pharmaceuticals | 45865-675 |
| Hydroxyzine hydrochloride | Hydroxyzine dihydrochloride 25 mg/1 | TabletOral | A-S Medication Solutions | 50090-5297 |
| Hydroxyzine hydrochloride | Hydroxyzine hydrochloride 50 mg/1 | TabletOral | Major Pharmaceuticals | 0904-7379 |
| Hydroxyzine hydrochloride | Hydroxyzine dihydrochloride 25 mg/1 | TabletOral | Golden State Medical Supply, Inc. | 51407-970 |
| Hydroxyzine hydrochloride | Hydroxyzine dihydrochloride 10 mg/1 | TabletOral | Golden State Medical Supply, Inc. | 51407-969 |
| Hydroxyzine hydrochloride | Hydroxyzine dihydrochloride 50 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-0487 |
| Hydroxyzine hydrochloride | Hydroxyzine dihydrochloride 50 mg/1 | TabletOral | Golden State Medical Supply, Inc. | 51407-971 |
| Hydroxyzine hydrochloride | Hydroxyzine dihydrochloride 10 mg/1 | TabletOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8563 |
| Hydroxyzine hydrochloride | Hydroxyzine dihydrochloride 50 mg/1 | TabletOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8564 |
| Hydroxyzine hydrochloride | Hydroxyzine dihydrochloride 25 mg/1 | TabletOral | Northwind Health Company, LLC | 51655-080 |
| Hydroxyzine hydrochloride | Hydroxyzine hydrochloride 50 mg/1 | TabletOral | Unit Dose Solutions, Inc. | 87441-039 |
| Hydroxyzine hydrochloride | Hydroxyzine dihydrochloride 25 mg/1 | TabletOral | Proficient Rx LP | 63187-733 |
| Hydroxyzine hydrochloride | Hydroxyzine dihydrochloride 50 mg/1 | TabletOral | Northwind Health Company, LLC | 51655-119 |
| Hydroxyzine hydrochloride | Hydroxyzine dihydrochloride 25 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-844 |
| Hydroxyzine hydrochloride | Hydroxyzine dihydrochloride 50 mg/1 | TabletOral | Proficient Rx LP | 63187-354 |
| Hydroxyzine Hydrochloride | Hydroxyzine dihydrochloride 50 mg/1 | TabletOral | Chartwell RX, LLC | 62135-575 |
| Hydroxyzine Hydrochloride | Hydroxyzine dihydrochloride 10 mg/1 | TabletOral | Chartwell RX, LLC | 62135-573 |
| Hydroxyzine hydrochloride | Hydroxyzine dihydrochloride 50 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 63629-4929 |
| Hydroxyzine Hydrochloride | Hydroxyzine dihydrochloride 25 mg/1 | TabletOral | Chartwell RX, LLC | 62135-574 |
| Hydroxyzine hydrochloride | Hydroxyzine dihydrochloride 25 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-851 |
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