Hydroxyzine Hydrochloride
- Product NDC
- 24658-781
- 11-digit product format
- 246580781
- Labeler code
- 24658
- Product ID
- 24658-781_384448bf-baa4-482b-91cd-585b03c62907
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydroxyzine Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- PURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS
- Application
- ANDA040604
- Marketing category
- ANDA
- Marketing start
- 2021-07-21
- Substance
- HYDROXYZINE DIHYDROCHLORIDE
- Active strength
- 10 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 | 10 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 |
|---|
| 24658-781-05 | Hydroxyzine Hydrochloride | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 3 |
| 24658-781-10 | Hydroxyzine Hydrochloride | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 24658-781 | HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [PURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS] | 2 | Current NDC, 2 package rows | 20250406_19fe26a9-eb1a-4c5b-a5e4-65223ee56ad1.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 24658-781-05 | 24658078105 | 500 TABLET, FILM COATED in 1 BOTTLE (24658-781-05) | 2024-10-24 | No | No | Historical |
| 24658-781-10 | 24658078110 | 1000 TABLET, FILM COATED in 1 BOTTLE (24658-781-10) | 2021-07-21 | No | No | Historical |