Hydroxyzine Hydrochloride
- Product NDC
- 0517-5601
- 11-digit product format
- 005175601
- Labeler code
- 0517
- Product ID
- 0517-5601_83de333d-1bf1-4168-8614-6bc79c26d5d0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydroxyzine Hydrochloride
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAMUSCULAR
- Labeler
- American Regent, Inc.
- Application
- ANDA087408
- Marketing category
- ANDA
- Marketing start
- 1990-09-30
- Substance
- HYDROXYZINE DIHYDROCHLORIDE
- Active strength
- 50 mg/mL
- 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 | 50 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 76755771U3 |
| Rxcui | 995270, 995285, 1794552, 1794554 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0517-5601-01 | Hydroxyzine Hydrochloride | 1 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION | 1 | | 18 |
| 0517-5601-25 | Hydroxyzine Hydrochloride | 25 in 1 TRAY | INJECTION, SOLUTION | 25 | | 18 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| HYDROXYZINE HYDROCHLORIDE | ACTIVE INGREDIENT | 76755771U3 | HYDROXYZINE HYDROCHLORIDE INJECTION, SOLUTION [AMERICAN REGENT, INC.] | 8 | |
| HYDROXYZINE | ACTIVE MOIETY | 30S50YM8OG | HYDROXYZINE HYDROCHLORIDE INJECTION, SOLUTION [AMERICAN REGENT, INC.] | 8 | |
| BENZYL ALCOHOL | INACTIVE INGREDIENT | LKG8494WBH | HYDROXYZINE HYDROCHLORIDE INJECTION, SOLUTION [AMERICAN REGENT, INC.] | 8 | |
| HYDROCHLORIC ACID | INACTIVE INGREDIENT | QTT17582CB | HYDROXYZINE HYDROCHLORIDE INJECTION, SOLUTION [AMERICAN REGENT, INC.] | 8 | |
| SODIUM HYDROXIDE | INACTIVE INGREDIENT | 55X04QC32I | HYDROXYZINE HYDROCHLORIDE INJECTION, SOLUTION [AMERICAN REGENT, INC.] | 8 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | HYDROXYZINE HYDROCHLORIDE INJECTION, SOLUTION [AMERICAN REGENT, INC.] | 8 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0517-5601 | HYDROXYZINE HYDROCHLORIDE INJECTION, SOLUTION [AMERICAN REGENT, INC.] | 17 | Current NDC, Legacy NDC, 2 package rows | 20240607_8af7e5ce-d9d9-44cc-9f2f-4ddbc89e758a.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 |
|---|
| 0517-5601-01 | 00517560101 | 1 mL in 1 VIAL, SINGLE-DOSE | 1 ml | | | | | Historical |
| 0517-5601-25 | 00517560125 | 25 VIAL, SINGLE-DOSE in 1 TRAY (0517-5601-25) / 1 mL in 1 VIAL, SINGLE-DOSE (0517-5601-01) | | 1990-09-30 | 0000-00-00 | No | No | Current |