HYDROXYZINE HYDROCHLORIDE
- Product NDC
- 80425-0394
- 11-digit product format
- 804250394
- Labeler code
- 80425
- Product ID
- 80425-0394_19b094e5-8afa-94c1-e063-6294a90a297f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- hydroxyzine hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Advanced Rx of Tennessee, LLC
- Application
- ANDA217652
- Marketing category
- ANDA
- Marketing start
- 2024-05-24
- 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 |
|---|
| 80425-0394-1 | HYDROXYZINE HYDROCHLORIDE | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 1 |
| 80425-0394-2 | HYDROXYZINE HYDROCHLORIDE | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 80425-0394 | HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [ADVANCED RX OF TENNESSEE, LLC] | 1 | Current NDC, 2 package rows | 20240601_19b08f92-da63-021f-e063-6394a90a16e2.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 80425-0394-1 | 80425039401 | 30 TABLET, FILM COATED in 1 BOTTLE (80425-0394-1) | 2024-05-24 | No | No | Historical |
| 80425-0394-2 | 80425039402 | 60 TABLET, FILM COATED in 1 BOTTLE (80425-0394-2) | 2024-05-24 | No | No | Historical |