HYDROXYZINE HYDROCHLORIDE
- Product NDC
- 83745-232
- 11-digit product format
- 837450232
- Labeler code
- 83745
- Product ID
- 83745-232_832542b8-0454-465e-a50d-a749dcd1a84d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- HYDROXYZINE HYDROCHLORIDE
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- APOZEAL PHARMACEUTICALS INC
- Application
- ANDA210634
- Marketing category
- ANDA
- Marketing start
- 2024-07-16
- Substance
- HYDROXYZINE DIHYDROCHLORIDE
- Active strength
- 10 mg/5mL
- Pharmacologic classes
- Antihistamine [EPC], Histamine Receptor Antagonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- HYDROXYZINE HYDROCHLORIDE
- Listing expiration
- 2027-12-31
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 |
|---|
| 83745-232-16 | HYDROXYZINE HYDROCHLORIDE | 473 mL in 1 BOTTLE | SOLUTION | 473 | | 8 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 83745-232 | HYDROXYZINE HYDROCHLORIDE SOLUTION [APOZEAL PHARMACEUTICALS INC] | 7 | Current NDC, 1 package rows | 20240730_87d4bbff-0498-4c26-86cb-7ce173afa0b6.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 83745-232-16 | 83745023216 | 473 mL in 1 BOTTLE (83745-232-16) | 473 ml | 2024-07-16 | No | No | Current |