Hydroxyzine Hydrochloride
- Product NDC
- 43063-519
- 11-digit product format
- 430630519
- Labeler code
- 43063
- Product ID
- 43063-519_4138e87f-3fda-bee4-e063-6294a90afa2b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydroxyzine Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- Application
- ANDA040788
- Marketing category
- ANDA
- Marketing start
- 2012-07-24
- 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 | Marketing start | Sample | Exclude flag | Status |
|---|
| 43063-519-30 | 43063051930 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-519-30) | 2012-07-25 | No | No | Historical |