Hydroxyzine hydrochloride
- Product NDC
- 53002-3901
- 11-digit product format
- 530023901
- Labeler code
- 53002
- Product ID
- 53002-3901_28053007-d310-4068-bf75-80451033d0e3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydroxyzine hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- RPK Pharmaceuticals, Inc.
- Application
- ANDA204279
- Marketing category
- ANDA
- Marketing start
- 2014-08-20
- Marketing end
- 0000-00-00
- Substance
- HYDROXYZINE HYDROCHLORIDE
- Active strength
- 10 mg/1
- Pharmacologic classes
- Antihistamine [EPC],Histamine Receptor Antagonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2021-12-31
- Current FDA listing
- Historical FDA.report record
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 | Marketing end | Sample | Exclude flag | Status |
|---|
| 53002-3901-1 | 53002390101 | 10 TABLET in 1 BOTTLE (53002-3901-1) | 10 tablet | 2020-01-01 | 0000-00-00 | No | No | Current |
| 53002-3901-2 | 53002390102 | 20 TABLET in 1 BOTTLE (53002-3901-2) | 20 tablet | 2020-01-01 | 0000-00-00 | No | No | Current |
| 53002-3901-3 | 53002390103 | 30 TABLET in 1 BOTTLE (53002-3901-3) | 30 tablet | 2020-01-01 | 0000-00-00 | No | No | Current |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Rx only | RPK Pharmaceuticals, Inc. | 2020-12-21 | HUMAN PRESCRIPTION DRUG LABEL | 1 |