Hydroxyzine Hydrochloride
- Product NDC
- 65162-671
- 11-digit product format
- 651620671
- Labeler code
- 65162
- Product ID
- 65162-671_6c929cf4-2a16-4956-b410-8e44db920604
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydroxyzine
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Amneal Pharmaceuticals LLC
- Application
- ANDA040808
- Marketing category
- ANDA
- Marketing start
- 2008-09-24
- 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 | 995218, 995258, 995281 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 65162-671-10 | Hydroxyzine Hydrochloride | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 5 |
| 65162-671-11 | Hydroxyzine Hydrochloride | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | | 5 |
| 65162-671-50 | Hydroxyzine Hydrochloride | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 65162-671 | HYDROXYZINE HYDROCHLORIDE (HYDROXYZINE) TABLET, FILM COATED [AMNEAL PHARMACEUTICALS LLC] | 5 | Current NDC, Legacy NDC, 3 package rows | 20241027_89901966-724b-4773-98b8-ea663ceabd53.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 |
|---|
| 65162-671-10 | 65162067110 | 100 TABLET, FILM COATED in 1 BOTTLE (65162-671-10) | 2008-09-24 | 0000-00-00 | No | No | Current |
| 65162-671-11 | 65162067111 | 1000 TABLET, FILM COATED in 1 BOTTLE (65162-671-11) | 2008-09-24 | 0000-00-00 | No | No | Current |
| 65162-671-50 | 65162067150 | 500 TABLET, FILM COATED in 1 BOTTLE (65162-671-50) | 2008-09-24 | 0000-00-00 | No | No | Current |