Prescription drug · ANDA
Hydroxyzine Pamoate NDC 76420-922
Hydroxyzine pamoate 100 mg/1 · Capsule · Oral · Asclemed USA, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 76420-922-01 | 76420092201 | 100 CAPSULE in 1 BOTTLE (76420-922-01)Marketed from Feb 18, 2025 | |
| 76420-922-30 | 76420092230 | 30 CAPSULE in 1 BOTTLE (76420-922-30)Marketed from Feb 18, 2025 | |
| 76420-922-60 | 76420092260 | 60 CAPSULE in 1 BOTTLE (76420-922-60)Marketed from Feb 18, 2025 | |
| 76420-922-90 | 76420092290 | 90 CAPSULE in 1 BOTTLE (76420-922-90)Marketed from Feb 18, 2025 |
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 — 100 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Asclemed USA, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 088488
- Marketing start
- Listing expires
- Other FDA classes
- Histamine Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 76420-922_2e63fa75-efcf-d9ee-e063-6394a90ab2d0SPL ID 2e63fa75-efcf-d9ee-e063-6394a90ab2d0SPL set ID 82187031-779e-47bc-943c-eb1a1ef30a7aRxCUI 995232, 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
N476420092201followed by a unit qualifier and the quantityPackage 76420-0922-01. 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 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.
Other NDCs under ANDA 088488
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 100 mg/1 | CapsuleOral | Teva Pharmaceuticals USA, Inc. | 0555-0324 |
| Hydroxyzine Pamoate | Hydroxyzine pamoate 100 mg/1 | CapsuleOral | Bryant Ranch Prepack | 63629-9244 |
| Hydroxyzine Pamoate | Hydroxyzine pamoate 100 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-2769 |