Hydroxyzine Hydrochloride
- Product NDC
- 68071-5133
- 11-digit product format
- 680715133
- Labeler code
- 68071
- Product ID
- 68071-5133_248b221c-df3f-dbf8-e063-6294a90a9251
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydroxyzine Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- NuCare Pharmaceuticals,Inc.
- Application
- ANDA040604
- Marketing category
- ANDA
- Marketing start
- 2015-03-31
- 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#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68071-5133-3 | Hydroxyzine Hydrochloride | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 4 |
| 68071-5133-6 | Hydroxyzine Hydrochloride | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68071-5133 | HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [NUCARE PHARMACEUTICALS,INC.] | 4 | Current NDC, Legacy NDC, 2 package rows | 20241017_99995bdb-a35f-7753-e053-2995a90a683c.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 |
|---|
| 68071-5133-3 | 68071513303 | 30 TABLET, FILM COATED in 1 BOTTLE (68071-5133-3) | 2024-10-15 | | No | No | Current |
| 68071-5133-6 | 68071513306 | 60 TABLET, FILM COATED in 1 BOTTLE (68071-5133-6) | 2019-12-13 | 0000-00-00 | No | No | Current |