Prescription drug · ANDA
Hydroxyzine hydrochloride NDC 76420-881
Hydroxyzine dihydrochloride 10 mg/1 · Tablet · Oral · Asclemed USA, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 76420-881-01 | 76420088101 | 100 TABLET in 1 BOTTLE (76420-881-01)Marketed from Dec 17, 2024 | |
| 76420-881-05 | 76420088105 | 500 TABLET in 1 BOTTLE (76420-881-05)Marketed from Dec 17, 2024 | |
| 76420-881-10 | 76420088110 | 1000 TABLET in 1 BOTTLE (76420-881-10)Marketed from Dec 17, 2024 | |
| 76420-881-30 | 76420088130 | 30 TABLET in 1 BOTTLE (76420-881-30)Marketed from Dec 17, 2024 | |
| 76420-881-60 | 76420088160 | 60 TABLET in 1 BOTTLE (76420-881-60)Marketed from Dec 17, 2024 | |
| 76420-881-90 | 76420088190 | 90 TABLET in 1 BOTTLE (76420-881-90)Marketed from Dec 17, 2024 |
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 hydrochloride
- Generic name (nonproprietary)
- hydroxyzine hydrochloride
- Active ingredients
- Hydroxyzine dihydrochloride — 10 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Asclemed USA, Inc.
- 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 76420-881_2979cc3d-941b-4936-e063-6394a90ab8f8SPL ID 2979cc3d-941b-4936-e063-6394a90ab8f8SPL set ID 4f3266f4-00a6-4c0c-bff2-e606913de894RxCUI 995218, 995258, 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
N476420088101followed by a unit qualifier and the quantityPackage 76420-0881-01. 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 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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