Hydroxyzine hydrochloride
- Product NDC
- 76420-883
- 11-digit product format
- 764200883
- Labeler code
- 76420
- Product ID
- 76420-883_2979cc3d-941b-4936-e063-6394a90ab8f8
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydroxyzine hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Asclemed USA, 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 |
|---|
| 76420-883-01 | 76420088301 | 100 TABLET in 1 BOTTLE (76420-883-01) | 100 tablet | 2024-12-17 | No | No | Historical |
| 76420-883-05 | 76420088305 | 500 TABLET in 1 BOTTLE (76420-883-05) | 500 tablet | 2024-12-17 | No | No | Historical |
| 76420-883-10 | 76420088310 | 1000 TABLET in 1 BOTTLE (76420-883-10) | 1000 tablet | 2024-12-17 | No | No | Historical |
| 76420-883-30 | 76420088330 | 30 TABLET in 1 BOTTLE (76420-883-30) | 30 tablet | 2024-12-17 | No | No | Historical |
| 76420-883-60 | 76420088360 | 60 TABLET in 1 BOTTLE (76420-883-60) | 60 tablet | 2024-12-17 | No | No | Historical |
| 76420-883-90 | 76420088390 | 90 TABLET in 1 BOTTLE (76420-883-90) | 90 tablet | 2024-12-17 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Rx only | Asclemed USA, Inc. | ASCLEMED USA INC. DBA ENOVACHEM | 2024-12-17 | HUMAN PRESCRIPTION DRUG LABEL | 1 |