Hydroxyzine hydrochloride
- Product NDC
- 0615-8564
- 11-digit product format
- 006158564
- Labeler code
- 0615
- Product ID
- 0615-8564_1ab953e6-830e-4845-8cca-9864f8002cdf
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydroxyzine hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- NCS HealthCare of KY, LLC dba Vangard Labs
- Application
- ANDA204279
- Marketing category
- ANDA
- Marketing start
- 2014-08-20
- Substance
- HYDROXYZINE DIHYDROCHLORIDE
- Active strength
- 50 mg/1
- Pharmacologic classes
- Antihistamine [EPC], Histamine Receptor Antagonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| 76755771U3 | HYDROXYZINE HYDROCHLORIDE | 2192-20-3 | Hydroxyzine hydrochloride |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 0615-8564-39 | 00615856439 | 30 TABLET in 1 BLISTER PACK (0615-8564-39) | 30 tablet | 2025-02-06 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Rx only | NCS HealthCare of KY, LLC dba Vangard Labs | 2025-03-20 | HUMAN PRESCRIPTION DRUG LABEL | 24 |