Hydroxyzine Hydrochloride
- Product NDC
- 51655-589
- 11-digit product format
- 516550589
- Labeler code
- 51655
- Product ID
- 51655-589_4a658ef3-b861-8b0b-e063-6294a90a3e54
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydroxyzine Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Northwind Health Company, LLC
- Application
- ANDA088618
- Marketing category
- ANDA
- Marketing start
- 2021-02-08
- Substance
- HYDROXYZINE DIHYDROCHLORIDE
- Active strength
- 25 mg/1
- 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 | 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 |
|---|
| 51655-589-25 | Hydroxyzine Hydrochloride | 60 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 60 | | 4 |
| 51655-589-52 | Hydroxyzine Hydrochloride | 30 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 30 | | 4 |
| 51655-589-53 | Hydroxyzine Hydrochloride | 10 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 10 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 51655-589 | HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [NORTHWIND PHARMACEUTICALS, LLC] | 3 | Current NDC, 3 package rows | 20240127_db0dce55-5984-7580-e053-2a95a90a3695.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 51655-589-25 | 51655058925 | 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-589-25) | 2024-01-10 | No | No | Current |
| 51655-589-52 | 51655058952 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-589-52) | 2023-06-27 | No | No | Current |
| 51655-589-53 | 51655058953 | 10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-589-53) | 2021-02-08 | No | No | Current |