Prescription drug · ANDA
Hydroxyzine Pamoate NDC 71205-483
Hydroxyzine pamoate 25 mg/1 · Capsule · Oral · Proficient Rx LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71205-483-30 | 7120504833071205048330 | 30 CAPSULE in 1 BOTTLE (71205-483-30)Marketed from Oct 8, 2020 | |
| 71205-483-60 | 7120504836071205048360 | 60 CAPSULE in 1 BOTTLE (71205-483-60)Marketed from Oct 8, 2020 | |
| 71205-483-90 | 7120504839071205048390 | 90 CAPSULE in 1 BOTTLE (71205-483-90)Marketed from Oct 8, 2020 |
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 — 25 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Proficient Rx LPNDC labeler code 71205
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 088496
- Marketing start
- Listing expires
- Other FDA classes
- Histamine Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 71205-483_66af6524-9e2e-41b4-b531-42ff21e350f1SPL ID 66af6524-9e2e-41b4-b531-42ff21e350f1SPL set ID b098e287-e489-4cdc-9171-7daf50380c1cRxCUI 995253UNII 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
N471205048330followed by a unit qualifier and the quantityPackage 71205-0483-30. 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 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…
Excerpt only. Read the full label for complete information.
About NDC 71205-483
- What is NDC 71205-483?
- 71205-483 is the product NDC for Hydroxyzine Pamoate, Hydroxyzine pamoate 25 mg/1 capsule, listed with the FDA by Proficient Rx LP. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Hydroxyzine Pamoate.
- What is the active ingredient?
- Hydroxyzine pamoate.
- Who is the labeler?
- Proficient Rx LP, NDC labeler code 71205. 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 Pamoate?
- 81 other product NDCs are listed under this name. See all Hydroxyzine Pamoate NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Hydroxyzine Pamoate products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| hydroxyzine pamoate | Hydroxyzine pamoate 25 mg/1 | CapsuleOral | Unit Dose Solutions, Inc. | 87441-087 | 87441-0087-01 |
| hydroxyzine pamoate | Hydroxyzine pamoate 25 mg/1 | CapsuleOral | Unit Dose Solutions, Inc. | 87441-040 | 87441-0040-01 |
| Hydroxyzine pamoate | Hydroxyzine pamoate 50 mg/1 | CapsuleOral | Unit Dose Solutions, Inc. | 87441-041 | 87441-0041-01 |
| Hydroxyzine pamoate | Hydroxyzine pamoate 50 mg/1 | CapsuleOral | Unit Dose Solutions, Inc. | 87441-042 | 87441-0042-01 |
| hydroxyzine pamoate | Hydroxyzine pamoate 25 mg/1 | CapsuleOral | Coupler LLC | 67046-0281 | 67046-0281-03 |
| Hydroxyzine pamoate | Hydroxyzine pamoate 50 mg/1 | CapsuleOral | Coupler LLC | 67046-0831 | 67046-0831-03 |
| hydroxyzine pamoate | Hydroxyzine pamoate 25 mg/1 | CapsuleOral | Coupler LLC | 67046-2086 | 67046-2086-03 |
| hydroxyzine pamoate | Hydroxyzine pamoate 50 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-4463 | 70518-4463-0070518-4463-01 |
| hydroxyzine pamoate | Hydroxyzine pamoate 25 mg/1 | CapsuleOral | Bryant Ranch Prepack | 72162-1054 | 72162-1054-03 |
| hydroxyzine pamoate | Hydroxyzine pamoate 50 mg/1 | CapsuleOral | Preferred Pharmaceuticals Inc. | 68788-8789 | 68788-8789-03 |
Other NDCs under ANDA 088496
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 25 mg/1 | CapsuleOral | Teva Pharmaceuticals USA, Inc. | 0555-0323 |
| Hydroxyzine Pamoate | Hydroxyzine pamoate 25 mg/1 | CapsuleOral | American Health Packaging | 60687-696 |
| Hydroxyzine Pamoate | Hydroxyzine pamoate 25 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-2187 |
| Hydroxyzine Pamoate | Hydroxyzine pamoate 25 mg/1 | CapsuleOral | Asclemed USA, Inc. | 76420-920 |