Hydroxyzine Hydrochloride
- Product NDC
- 55154-7994
- 11-digit product format
- 551547994
- Labeler code
- 55154
- Product ID
- 55154-7994_9db03a3f-e0ed-46b1-948d-667383a6bf61
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydroxyzine Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Cardinal Health 107, LLC
- Application
- ANDA040604
- Marketing category
- ANDA
- Marketing start
- 2015-03-31
- Marketing end
- 2026-08-31
- Substance
- HYDROXYZINE DIHYDROCHLORIDE
- Active strength
- 25 mg/1
- Pharmacologic classes
- Antihistamine [EPC], Histamine Receptor Antagonists [MoA]
- NDC exclude flag
- No
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Hydroxyzine Hydrochloride
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| HYDROXYZINE HYDROCHLORIDE | 25 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 76755771U3 |
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 |
|---|
| 55154-7994-0 | Hydroxyzine Hydrochloride | 1 in 1 BLISTER PACK | TABLET, FILM COATED | 1 | | 7 |
| 55154-7994-0 | Hydroxyzine Hydrochloride | 10 in 1 BAG | TABLET, FILM COATED | 10 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 55154-7994 | HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [CARDINAL HEALTH 107, LLC] | 6 | Current NDC, Legacy NDC, 2 package rows | 20250514_157fbedc-b65d-455f-adb5-e7554282e033.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 |
|---|
| 55154-7994-0 | 55154799400 | 10 BLISTER PACK in 1 BAG (55154-7994-0) / 1 TABLET, FILM COATED in 1 BLISTER PACK | 10 blister pack | 2015-03-31 | 2026-08-31 | No | No | Current |