Hydroxyzine hydrochloride
- Product NDC
- 0904-7378
- 11-digit product format
- 009047378
- Labeler code
- 0904
- Product ID
- 0904-7378_462940f7-5dba-4ca2-829d-e0a8a72579e5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydroxyzine hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Major Pharmaceuticals
- Application
- ANDA204279
- Marketing category
- ANDA
- Marketing start
- 2023-08-01
- Substance
- HYDROXYZINE DIHYDROCHLORIDE
- Active strength
- 25 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 |
|---|
| 0904-7378-40 | 00904737840 | 500 TABLET in 1 BOTTLE (0904-7378-40) | 500 tablet | 2023-08-01 | No | No | Historical |
| 0904-7378-80 | 00904737880 | 1000 TABLET in 1 BOTTLE (0904-7378-80) | 1000 tablet | 2023-08-01 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Rx only | Major Pharmaceuticals | 2025-11-10 | HUMAN PRESCRIPTION DRUG LABEL | 4 |
| Rx only | Aphena Pharma Solutions - Tennessee, LLC | 2024-06-28 | HUMAN PRESCRIPTION DRUG LABEL | 1 |