Hydroxyzine Hydrochloride
- Product NDC
- 59651-501
- 11-digit product format
- 596510501
- Labeler code
- 59651
- Product ID
- 59651-501_86a715f8-fbfb-4d28-a144-27581d6aa1bb
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydroxyzine Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Aurobindo Pharma Limited
- Application
- ANDA087871
- Marketing category
- ANDA
- Marketing start
- 2021-10-07
- Substance
- HYDROXYZINE DIHYDROCHLORIDE
- Active strength
- 50 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 | 50 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 76755771U3 |
| Rxcui | 995218, 995258, 995281 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 59651-501-01 | Hydroxyzine Hydrochloride | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 2 |
| 59651-501-05 | Hydroxyzine Hydrochloride | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 2 |
| 59651-501-99 | Hydroxyzine Hydrochloride | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 59651-501 | HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 1 | Current NDC, Legacy NDC, 3 package rows | 20220811_9de2de56-614f-4294-8794-d30758cf5f70.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 59651-501-01 | 59651050101 | 100 TABLET, FILM COATED in 1 BOTTLE (59651-501-01) | 2021-10-07 | 0000-00-00 | No | No | Current |
| 59651-501-05 | 59651050105 | 500 TABLET, FILM COATED in 1 BOTTLE (59651-501-05) | 2021-10-07 | 0000-00-00 | No | No | Current |
| 59651-501-99 | 59651050199 | 1000 TABLET, FILM COATED in 1 BOTTLE (59651-501-99) | 2021-10-07 | 0000-00-00 | No | No | Current |