Hydroxyzine hydrochloride
- Product NDC
- 76420-881
- 11-digit product format
- 764200881
- Labeler code
- 76420
- Product ID
- 76420-881_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
- 10 mg/1
- Pharmacologic classes
- Antihistamine [EPC], Histamine Receptor Antagonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data
- Finished product
- Yes
- Brand name base
- Hydroxyzine hydrochloride
- Listing expiration
- 2026-12-31
Active Ingredients
| Ingredient | Strength |
|---|
| HYDROXYZINE DIHYDROCHLORIDE | 10 mg/1 |
Harmonized Identifiers
| Field | Values |
|---|
| Unii | 76755771U3 |
| Rxcui | 995218, 995258, 995281 |
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 |
|---|
| 76420-881-01 | 76420088101 | 100 TABLET in 1 BOTTLE (76420-881-01) | 100 tablet | 2024-12-17 | No | No | Current |
| 76420-881-05 | 76420088105 | 500 TABLET in 1 BOTTLE (76420-881-05) | 500 tablet | 2024-12-17 | No | No | Current |
| 76420-881-10 | 76420088110 | 1000 TABLET in 1 BOTTLE (76420-881-10) | 1000 tablet | 2024-12-17 | No | No | Current |
| 76420-881-30 | 76420088130 | 30 TABLET in 1 BOTTLE (76420-881-30) | 30 tablet | 2024-12-17 | No | No | Current |
| 76420-881-60 | 76420088160 | 60 TABLET in 1 BOTTLE (76420-881-60) | 60 tablet | 2024-12-17 | No | No | Current |
| 76420-881-90 | 76420088190 | 90 TABLET in 1 BOTTLE (76420-881-90) | 90 tablet | 2024-12-17 | No | No | Current |
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 |