Hydroxyzine Hydrochloride
- Product NDC
- 54838-502
- 11-digit product format
- 548380502
- Labeler code
- 54838
- Product ID
- 54838-502_823645dc-4e60-4279-97fa-ca0d1c1d7ad8
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydroxyzine Hydrochloride
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Lannett Company, Inc.
- Application
- ANDA201674
- Marketing category
- ANDA
- Marketing start
- 2013-08-21
- Substance
- HYDROXYZINE DIHYDROCHLORIDE
- Active strength
- 10 mg/5mL
- 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 table| Ingredient | Strength |
|---|
| HYDROXYZINE DIHYDROCHLORIDE | 10 mg/5mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 76755771U3 |
| Rxcui | 995241 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 54838-502-80 | Hydroxyzine Hydrochloride | 473 mL in 1 BOTTLE, PLASTIC | SOLUTION | 473 | | 21 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 54838-502 | HYDROXYZINE HYDROCHLORIDE SOLUTION [LANNETT COMPANY, INC.] | 21 | Current NDC, Legacy NDC, 1 package rows | 20240809_a4fb61ae-aad6-4bd6-83fc-8b227f175df9.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 54838-502-80 | 54838050280 | 473 mL in 1 BOTTLE, PLASTIC (54838-502-80) | 473 ml | 2013-08-21 | 0000-00-00 | No | No | Current |