Hydroxyzine Hydrochloride
- Product NDC
- 50090-6653
- 11-digit product format
- 500906653
- Labeler code
- 50090
- Product ID
- 50090-6653_ef41a70f-c61b-4096-8566-0f08256a198c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydroxyzine Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- A-S Medication Solutions
- Application
- ANDA040602
- Marketing category
- ANDA
- Marketing start
- 2015-03-31
- 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 | Marketing start | Sample | Exclude flag | Status |
|---|
| 50090-6653-1 | 50090665301 | 28 TABLET, FILM COATED in 1 BOTTLE (50090-6653-1) | 2023-08-30 | No | No | Historical |