Hydroxyzine hydrochloride
- Product NDC
- 68788-7854
- 11-digit product format
- 687887854
- Labeler code
- 68788
- Product ID
- 68788-7854_e3a724e1-eb77-4678-898d-d3ad022b19b8
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydroxyzine hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Preferred Pharmaceuticals Incl
- Application
- ANDA204279
- Marketing category
- ANDA
- Marketing start
- 2021-01-29
- Substance
- HYDROXYZINE HYDROCHLORIDE
- 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 HYDROCHLORIDE | 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 |
|---|
| 68788-7854-3 | Hydroxyzine hydrochloride | 30 in 1 BOTTLE | TABLET | 30 | | 6 |
| 68788-7854-6 | Hydroxyzine hydrochloride | 60 in 1 BOTTLE | TABLET | 60 | | 6 |
| 68788-7854-9 | Hydroxyzine hydrochloride | 90 in 1 BOTTLE | TABLET | 90 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68788-7854 | HYDROXYZINE HYDROCHLORIDE TABLET [PREFERRED PHARMACEUTICALS INCL] | 4 | Current NDC, Legacy NDC, 3 package rows | 20240601_63fdf791-1a58-45ba-8ef2-15b80bb24f23.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 68788-7854-3 | 68788785403 | 30 TABLET in 1 BOTTLE (68788-7854-3) | 30 tablet | 2021-01-29 | 0000-00-00 | No | No | Current |
| 68788-7854-6 | 68788785406 | 60 TABLET in 1 BOTTLE (68788-7854-6) | 60 tablet | 2021-01-29 | 0000-00-00 | No | No | Current |
| 68788-7854-9 | 68788785409 | 90 TABLET in 1 BOTTLE (68788-7854-9) | 90 tablet | 2021-01-29 | 0000-00-00 | No | No | Current |