Hydroxyzine Hydrochloride
- Product NDC
- 42806-159
- 11-digit product format
- 428060159
- Labeler code
- 42806
- Product ID
- 42806-159_5e33c30d-cf33-4d61-98ca-eab9aab2ddf3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydroxyzine Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Epic Pharma, LLC
- Application
- ANDA040604
- Marketing category
- ANDA
- Marketing start
- 2015-03-31
- 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 |
|---|
| 42806-159-01 | Hydroxyzine Hydrochloride | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 12 |
| 42806-159-05 | Hydroxyzine Hydrochloride | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 12 |
| 42806-159-10 | Hydroxyzine Hydrochloride | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | | 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 [EPIC PHARMA, LLC] | 3 | |
| HYDROXYZINE | ACTIVE MOIETY | 30S50YM8OG | HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [EPIC PHARMA, LLC] | 3 | |
| CARNAUBA WAX | INACTIVE INGREDIENT | R12CBM0EIZ | HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [EPIC PHARMA, LLC] | 3 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [EPIC PHARMA, LLC] | 3 | |
| CROSPOVIDONE | INACTIVE INGREDIENT | 68401960MK | HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [EPIC PHARMA, LLC] | 3 | |
| D&C YELLOW NO. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [EPIC PHARMA, LLC] | 3 | |
| FD&C BLUE NO. 2 | INACTIVE INGREDIENT | L06K8R7DQK | HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [EPIC PHARMA, LLC] | 3 | |
| FD&C RED NO. 40 | INACTIVE INGREDIENT | WZB9127XOA | HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [EPIC PHARMA, LLC] | 3 | |
| FD&C YELLOW NO. 6 | INACTIVE INGREDIENT | H77VEI93A8 | HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [EPIC PHARMA, LLC] | 3 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [EPIC PHARMA, LLC] | 3 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [EPIC PHARMA, LLC] | 3 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [EPIC PHARMA, LLC] | 3 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [EPIC PHARMA, LLC] | 3 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [EPIC PHARMA, LLC] | 3 | |
| POLYVINYL ALCOHOL | INACTIVE INGREDIENT | 532B59J990 | HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [EPIC PHARMA, LLC] | 3 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [EPIC PHARMA, LLC] | 3 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [EPIC PHARMA, LLC] | 3 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [EPIC PHARMA, LLC] | 3 | |
| TRIACETIN | INACTIVE INGREDIENT | XHX3C3X673 | HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [EPIC PHARMA, LLC] | 3 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 42806-159 | HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [EPIC PHARMA, LLC] | 12 | Current NDC, Legacy NDC, 3 package rows | 20250209_82b015dc-999c-46a4-bcaa-a4c81a193b68.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 |
|---|
| 42806-159-01 | 42806015901 | 100 TABLET, FILM COATED in 1 BOTTLE (42806-159-01) | 2015-03-31 | 0000-00-00 | No | No | Current |
| 42806-159-05 | 42806015905 | 500 TABLET, FILM COATED in 1 BOTTLE (42806-159-05) | 2015-03-31 | 0000-00-00 | No | No | Current |
| 42806-159-10 | 42806015910 | 1000 TABLET, FILM COATED in 1 BOTTLE (42806-159-10) | 2015-03-31 | 0000-00-00 | No | No | Current |