Hydroxyzine Hydrochloride
- Product NDC
- 63187-494
- 11-digit product format
- 631870494
- Labeler code
- 63187
- Product ID
- 63187-494_ee6acff5-b3af-457d-bc54-b822635405a3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydroxyzine Hydrochloride
- Dosage form
- SYRUP
- Route
- ORAL
- Labeler
- Proficient Rx LP
- Application
- ANDA087294
- Marketing category
- ANDA
- Marketing start
- 1995-03-09
- 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 |
|---|
| 63187-494-04 | Hydroxyzine Hydrochloride | 118 mL in 1 BOTTLE, PLASTIC | SYRUP | 118 | | 5 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63187-494 | HYDROXYZINE HYDROCHLORIDE SYRUP [PROFICIENT RX LP] | 5 | Current NDC, Legacy NDC, 1 package rows | 20221020_bcddc5ce-6cfb-4a09-8e6c-c956b65e3188.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 |
|---|
| 63187-494-04 | 63187049404 | 118 mL in 1 BOTTLE, PLASTIC (63187-494-04) | 118 ml | 2015-02-02 | 0000-00-00 | No | No | Current |