Hydroxyzine hydrochloride
- Product NDC
- 43063-779
- 11-digit product format
- 430630779
- Labeler code
- 43063
- Product ID
- 43063-779_39fa1f3a-e737-577e-e063-6294a90a8d32
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydroxyzine hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- Application
- ANDA204279
- Marketing category
- ANDA
- Marketing start
- 2014-08-20
- Substance
- HYDROXYZINE DIHYDROCHLORIDE
- Active strength
- 50 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 | 50 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 76755771U3 |
| Rxcui | 995281 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 43063-779-30 | Hydroxyzine hydrochloride | 30 in 1 BOTTLE, PLASTIC | TABLET | 30 | | 25 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43063-779 | HYDROXYZINE HYDROCHLORIDE TABLET [PD-RX PHARMACEUTICALS, INC.] | 24 | Current NDC, Legacy NDC, 1 package rows | 20240608_ca015a35-1f94-4f92-9143-3f149982d316.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 |
|---|
| 43063-779-30 | 43063077930 | 30 TABLET in 1 BOTTLE, PLASTIC (43063-779-30) | 30 tablet | 2017-08-07 | 0000-00-00 | No | No | Current |