Hydroxyzine
- Product NDC
- 0404-9878
- 11-digit product format
- 004049878
- Labeler code
- 0404
- Product ID
- 0404-9878_5d9b6c38-5a58-4278-999a-f430f34aafd4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydroxyzine
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAMUSCULAR
- Labeler
- Henry Schein, Inc.
- Application
- ANDA087408
- Marketing category
- ANDA
- Marketing start
- 2022-01-17
- 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
- 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 | 1794552 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0404-9878-02 | Hydroxyzine | 2 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION | 2 | | 5 |
| 0404-9878-02 | Hydroxyzine | 1 in 1 BAG | INJECTION, SOLUTION | 1 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0404-9878 | HYDROXYZINE INJECTION, SOLUTION [HENRY SCHEIN, INC.] | 4 | Current NDC, Legacy NDC, 2 package rows | 20240806_851e7439-bb0a-4a09-9279-e3c33bff8965.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0404-9878-02 | 00404987802 | 1 VIAL, SINGLE-DOSE in 1 BAG (0404-9878-02) / 2 mL in 1 VIAL, SINGLE-DOSE | 2022-01-17 | 0000-00-00 | No | No | Current |