HydrOXYzine Hydrochloride
- Product NDC
- 50090-7582
- 11-digit product format
- 500907582
- Labeler code
- 50090
- Product ID
- 50090-7582_d0abf9e3-d92e-445f-b626-a81b499d6e47
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- HydrOXYzine Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- A-S Medication Solutions
- Application
- ANDA040840
- Marketing category
- ANDA
- Marketing start
- 2009-11-11
- 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 |
|---|
| 50090-7582-1 | HydrOXYzine Hydrochloride | 28 in 1 BOTTLE | TABLET | 28 | | 5 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 50090-7582-1 | 50090758201 | 28 TABLET in 1 BOTTLE (50090-7582-1) | 28 tablet | 2025-06-18 | No | No | Current |