Hydroxyzine Hydrochloride
- Product NDC
- 10702-010
- 11-digit product format
- 107020010
- Labeler code
- 10702
- Product ID
- 10702-010_eff46bea-a884-5878-e053-2a95a90ae664
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- hydroxyzine hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- KVK-Tech, Inc.
- Application
- ANDA040786
- Marketing category
- ANDA
- Marketing start
- 2012-07-24
- Substance
- HYDROXYZINE DIHYDROCHLORIDE
- Active strength
- 10 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 | 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 |
|---|
| 10702-010-01 | Hydroxyzine Hydrochloride | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 12 |
| 10702-010-10 | Hydroxyzine Hydrochloride | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | | 12 |
| 10702-010-50 | Hydroxyzine Hydrochloride | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 12 |
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 HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [KVK-TECH, INC.] | 2 | |
| HYDROXYZINE | ACTIVE MOIETY | 30S50YM8OG | HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [KVK-TECH, INC.] | 2 | |
| CARNAUBA WAX | INACTIVE INGREDIENT | R12CBM0EIZ | HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [KVK-TECH, INC.] | 2 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [KVK-TECH, INC.] | 2 | |
| CROSPOVIDONE | INACTIVE INGREDIENT | 68401960MK | HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [KVK-TECH, INC.] | 2 | |
| GLYCERYL MONOSTEARATE | INACTIVE INGREDIENT | 230OU9XXE4 | HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [KVK-TECH, INC.] | 2 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [KVK-TECH, INC.] | 2 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [KVK-TECH, INC.] | 2 | |
| POLYVINYL ALCOHOL | INACTIVE INGREDIENT | 532B59J990 | HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [KVK-TECH, INC.] | 2 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [KVK-TECH, INC.] | 2 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [KVK-TECH, INC.] | 2 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [KVK-TECH, INC.] | 2 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [KVK-TECH, INC.] | 2 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [KVK-TECH, INC.] | 2 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 10702-010 | HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [KVK-TECH, INC.] | 12 | Current NDC, Legacy NDC, 3 package rows | 20230126_adc4cb73-77c6-48ff-aaf2-b3568d53de1f.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 |
|---|
| 10702-010-01 | 10702001001 | 100 TABLET, FILM COATED in 1 BOTTLE (10702-010-01) | 2012-07-24 | 0000-00-00 | No | No | Current |
| 10702-010-10 | 10702001010 | 1000 TABLET, FILM COATED in 1 BOTTLE (10702-010-10) | 2012-07-24 | 0000-00-00 | No | No | Current |
| 10702-010-50 | 10702001050 | 500 TABLET, FILM COATED in 1 BOTTLE (10702-010-50) | 2012-07-24 | 0000-00-00 | No | No | Current |