Hydroxyzine Hydrochloride
- Product NDC
- 10544-227
- 11-digit product format
- 105440227
- Labeler code
- 10544
- Product ID
- 10544-227_31a005d8-7b61-4cac-bac5-78b0c09d46ca
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydroxyzine
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Blenheim Pharmacal, Inc.
- Application
- ANDA040808
- Marketing category
- ANDA
- Marketing start
- 2013-11-18
- Marketing end
- 0000-00-00
- Substance
- HYDROXYZINE HYDROCHLORIDE
- Active strength
- 50 mg/1
- Pharmacologic classes
- Antihistamine [EPC],Histamine Receptor Antagonists [MoA]
- NDC exclude flag
- E
- Listing certified through
- 2017-12-31
- Current FDA listing
- Historical FDA.report record
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 |
|---|
| 10544-227-30 | Hydroxyzine Hydrochloride | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 1 |
| 10544-227-90 | Hydroxyzine Hydrochloride | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 1 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| HYDROXYZINE HYDROCHLORIDE | ACTIVE INGREDIENT | 76755771U3 | HYDROXYZINE HYDROCHLORIDE (HYDROXYZINE) TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] | 1 | |
| HYDROXYZINE | ACTIVE MOIETY | 30S50YM8OG | HYDROXYZINE HYDROCHLORIDE (HYDROXYZINE) TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] | 1 | |
| ANHYDROUS LACTOSE | INACTIVE INGREDIENT | 3SY5LH9PMK | HYDROXYZINE HYDROCHLORIDE (HYDROXYZINE) TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] | 1 | |
| CARNAUBA WAX | INACTIVE INGREDIENT | R12CBM0EIZ | HYDROXYZINE HYDROCHLORIDE (HYDROXYZINE) TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | HYDROXYZINE HYDROCHLORIDE (HYDROXYZINE) TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] | 1 | |
| CROSPOVIDONE | INACTIVE INGREDIENT | 68401960MK | HYDROXYZINE HYDROCHLORIDE (HYDROXYZINE) TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] | 1 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | HYDROXYZINE HYDROCHLORIDE (HYDROXYZINE) TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | HYDROXYZINE HYDROCHLORIDE (HYDROXYZINE) TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] | 1 | |
| POLYDEXTROSE | INACTIVE INGREDIENT | VH2XOU12IE | HYDROXYZINE HYDROCHLORIDE (HYDROXYZINE) TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] | 1 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | HYDROXYZINE HYDROCHLORIDE (HYDROXYZINE) TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | HYDROXYZINE HYDROCHLORIDE (HYDROXYZINE) TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] | 1 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | HYDROXYZINE HYDROCHLORIDE (HYDROXYZINE) TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | HYDROXYZINE HYDROCHLORIDE (HYDROXYZINE) TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] | 1 | |
| TRIACETIN | INACTIVE INGREDIENT | XHX3C3X673 | HYDROXYZINE HYDROCHLORIDE (HYDROXYZINE) TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 10544-227 | HYDROXYZINE HYDROCHLORIDE (HYDROXYZINE) TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] | 1 | Legacy NDC, 2 package rows | 20140205_31a005d8-7b61-4cac-bac5-78b0c09d46ca.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 10544-227-30 | 10544022730 | 30 in 1 BOTTLE | Historical |
| 10544-227-90 | 10544022790 | 90 in 1 BOTTLE | Historical |