Hydroxyzine Hydrochloride
- Product NDC
- 68071-5133
- 11-digit product format
- 680715133
- Labeler code
- 68071
- Product ID
- 68071-5133_248b221c-df3f-dbf8-e063-6294a90a9251
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydroxyzine Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- NuCare Pharmaceuticals,Inc.
- Application
- ANDA040604
- Marketing category
- ANDA
- Marketing start
- 2015-03-31
- 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 |
|---|
| 68071-5133-3 | 68071513303 | 30 TABLET, FILM COATED in 1 BOTTLE (68071-5133-3) | 2024-10-15 | No | No | Historical |
| 68071-5133-6 | 68071513306 | 60 TABLET, FILM COATED in 1 BOTTLE (68071-5133-6) | 2019-12-13 | No | No | Historical |