HYDROXYZINE HYDROCHLORIDE
- Product NDC
- 50090-7331
- 11-digit product format
- 500907331
- Labeler code
- 50090
- Product ID
- 50090-7331_fe69a194-e17b-4a41-b273-85e126eb7619
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- hydroxyzine hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- A-S Medication Solutions
- Application
- ANDA217652
- Marketing category
- ANDA
- Marketing start
- 2023-08-22
- Substance
- HYDROXYZINE DIHYDROCHLORIDE
- Active strength
- 25 mg/1
- 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 | 25 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 76755771U3 |
| Rxcui | 995258 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 50090-7331-0 | HYDROXYZINE HYDROCHLORIDE | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 50090-7331-0 | 50090733100 | 30 TABLET, FILM COATED in 1 BOTTLE (50090-7331-0) | 2024-10-15 | No | No | Current |