Prescription drug · ANDA
hydroxyzine pamoate NDC 14539-675
Hydroxyzine pamoate 50 mg/1 · Capsule · Oral · Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 14539-675-01 | 14539067501 | 100 CAPSULE in 1 CONTAINER (14539-675-01)Marketed from Apr 23, 2019 | |
| 14539-675-05 | 14539067505 | 500 CAPSULE in 1 CONTAINER (14539-675-05)Marketed from Apr 23, 2019 |
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 pamoate
- Generic name (nonproprietary)
- hydroxyzine pamoate
- Active ingredients
- Hydroxyzine pamoate — 50 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 201507
- Marketing start
- Listing expires
- Other FDA classes
- Histamine Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 14539-675_843627c2-146c-4715-b5b5-8c5c80a8f615SPL ID 843627c2-146c-4715-b5b5-8c5c80a8f615SPL set ID 734d32c8-38d3-430f-a2b3-539e03a3687aRxCUI 995253, 995278UNII M20215MUFR
- 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
N414539067501followed by a unit qualifier and the quantityPackage 14539-0675-01. 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 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 premedication and following general anesthesia, Hydroxyzine may potentiate meperidine (Demerol®) 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.
Other NDCs under ANDA 201507
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 pamoate | Hydroxyzine pamoate 50 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-1265 |
| hydroxyzine pamoate | Hydroxyzine pamoate 25 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-1325 |
| Hydroxyzine Pamoate | Hydroxyzine pamoate 25 mg/1 | CapsuleOral | Direct_Rx | 72189-009 |
| hydroxyzine pamoate | Hydroxyzine pamoate 50 mg/1 | CapsuleOral | Golden State Medical Supply, Inc. | 51407-002 |
| hydroxyzine pamoate | Hydroxyzine pamoate 25 mg/1 | CapsuleOral | Golden State Medical Supply, Inc. | 51407-001 |
| hydroxyzine pamoate | Hydroxyzine pamoate 25 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-4385 |
| hydroxyzine pamoate | Hydroxyzine pamoate 50 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-4463 |
| hydroxyzine pamoate | Hydroxyzine pamoate 25 mg/1 | CapsuleOral | Coupler LLC | 67046-2086 |
| hydroxyzine pamoate | Hydroxyzine pamoate 25 mg/1 | CapsuleOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-773 |
| hydroxyzine pamoate | Hydroxyzine pamoate 50 mg/1 | CapsuleOral | Preferred Pharmaceuticals Inc. | 68788-8789 |
| Hydroxyzine pamoate | Hydroxyzine pamoate 50 mg/1 | CapsuleOral | Chartwell RX, LLC | 62135-817 |
| Hydroxyzine pamoate | Hydroxyzine pamoate 25 mg/1 | CapsuleOral | Chartwell RX, LLC | 62135-816 |
| hydroxyzine pamoate | Hydroxyzine pamoate 50 mg/1 | CapsuleOral | Northwind Health Company, LLC | 82868-046 |
| hydroxyzine pamoate | Hydroxyzine pamoate 25 mg/1 | CapsuleOral | Major Pharmaceuticals | 0904-7065 |
| hydroxyzine pamoate | Hydroxyzine pamoate 50 mg/1 | CapsuleOral | NuCare Pharmaceuticals,Inc. | 68071-3583 |
| hydroxyzine pamoate | Hydroxyzine pamoate 25 mg/1 | CapsuleOral | Proficient Rx LP | 71205-433 |
| hydroxyzine pamoate | Hydroxyzine pamoate 25 mg/1 | CapsuleOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-883 |
| hydroxyzine pamoate | Hydroxyzine pamoate 25 mg/1 | CapsuleOral | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 14539-674 |
| hydroxyzine pamoate | Hydroxyzine pamoate 25 mg/1 | CapsuleOral | Northwind Health Company, LLC | 51655-725 |
| hydroxyzine pamoate | Hydroxyzine pamoate 25 mg/1 | CapsuleOral | Preferred Pharmaceuticals, Inc. | 68788-7767 |
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