Hydroxyzine hydrochloride
- Product NDC
- 43063-779
- 11-digit product format
- 430630779
- Labeler code
- 43063
- Product ID
- 43063-779_39fa1f3a-e737-577e-e063-6294a90a8d32
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydroxyzine hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- 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 |
|---|
| 43063-779-30 | 43063077930 | 30 TABLET in 1 BOTTLE, PLASTIC (43063-779-30) | 30 tablet | 2017-08-07 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Rx only | PD-Rx Pharmaceuticals, Inc. | 2025-07-15 | HUMAN PRESCRIPTION DRUG LABEL | 25 |