Hydroxyzine Hydrochloride
- Product NDC
- 50090-6657
- 11-digit product format
- 500906657
- Labeler code
- 50090
- Product ID
- 50090-6657_f8934174-e679-418a-a77c-9d3c57f15ce4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydroxyzine Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- A-S Medication Solutions
- Application
- ANDA040602
- Marketing category
- ANDA
- Marketing start
- 2015-03-31
- 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 |
|---|
| 50090-6657-0 | Hydroxyzine Hydrochloride | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50090-6657 | HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS] | 1 | Current NDC, 1 package rows | 20240105_e83de74d-b2e0-45c5-b072-170a96216d3a.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 50090-6657-0 | 50090665700 | 90 TABLET, FILM COATED in 1 BOTTLE (50090-6657-0) | 2023-08-30 | No | No | Current |