Hydroxyzine Hydrochloride
- Product NDC
- 0093-5062
- 11-digit product format
- 000935062
- Labeler code
- 0093
- Product ID
- 0093-5062_ce53cc7b-dd6d-4a1b-b64b-ca0b45f67512
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydroxyzine Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Teva Pharmaceuticals USA, Inc.
- Application
- ANDA088619
- Marketing category
- ANDA
- Marketing start
- 2012-10-22
- 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 | 995218, 995258, 995281 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0093-5062-01 | Hydroxyzine Hydrochloride | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 17 |
| 0093-5062-05 | Hydroxyzine Hydrochloride | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 17 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| HYDROXYZINE HYDROCHLORIDE | ACTIVE INGREDIENT | 76755771U3 | HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] | 6 | |
| HYDROXYZINE | ACTIVE MOIETY | 30S50YM8OG | HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] | 6 | |
| ANHYDROUS LACTOSE | INACTIVE INGREDIENT | 3SY5LH9PMK | HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] | 6 | |
| CARNAUBA WAX | INACTIVE INGREDIENT | R12CBM0EIZ | HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] | 6 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] | 6 | |
| CROSPOVIDONE | INACTIVE INGREDIENT | 68401960MK | HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] | 6 | |
| HYPROMELLOSE 2910 (3 MPA.S) | INACTIVE INGREDIENT | 0VUT3PMY82 | HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] | 6 | |
| HYPROMELLOSE 2910 (50 MPA.S) | INACTIVE INGREDIENT | 1IVH67816N | HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] | 6 | |
| HYPROMELLOSE 2910 (6 MPA.S) | INACTIVE INGREDIENT | 0WZ8WG20P6 | HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] | 6 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] | 6 | |
| POLYDEXTROSE | INACTIVE INGREDIENT | VH2XOU12IE | HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] | 6 | |
| POLYETHYLENE GLYCOL 8000 | INACTIVE INGREDIENT | Q662QK8M3B | HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] | 6 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] | 6 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] | 6 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] | 6 | |
| TRIACETIN | INACTIVE INGREDIENT | XHX3C3X673 | HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] | 6 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0093-5062 | HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA, INC.] | 16 | Current NDC, Legacy NDC, 2 package rows | 20220601_80309ec1-e5d5-4454-b8ce-67d7e6805e44.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 |
|---|
| 0093-5062-01 | 00093506201 | 100 TABLET, FILM COATED in 1 BOTTLE (0093-5062-01) | 2013-03-11 | 0000-00-00 | No | No | Current |
| 0093-5062-05 | 00093506205 | 500 TABLET, FILM COATED in 1 BOTTLE (0093-5062-05) | 2012-10-22 | 0000-00-00 | No | No | Current |