Hydroxyzine Hydrochloride
- Product NDC
- 53002-3900
- 11-digit product format
- 530023900
- Labeler code
- 53002
- Product ID
- 53002-3900_7e49822c-67af-4e66-a3bb-b13ce0feb92e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydroxyzine Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- RPK Pharmaceuticals, Inc.
- Application
- ANDA088618
- Marketing category
- ANDA
- Marketing start
- 2012-10-09
- Marketing end
- 0000-00-00
- Substance
- HYDROXYZINE HYDROCHLORIDE
- Active strength
- 25 mg/1
- Pharmacologic classes
- Antihistamine [EPC],Histamine Receptor Antagonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2021-12-31
- 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 |
|---|
| 53002-3900-1 | Hydroxyzine Hydrochloride | 10 in 1 BOTTLE | TABLET, FILM COATED | 10 | | 3 |
| 53002-3900-2 | Hydroxyzine Hydrochloride | 20 in 1 BOTTLE | TABLET, FILM COATED | 20 | | 3 |
| 53002-3900-3 | Hydroxyzine Hydrochloride | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 53002-3900 | HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [RPK PHARMACEUTICALS, INC.] | 3 | Legacy NDC, 3 package rows | 20201217_d307dc62-a7fb-4013-8f3c-28280e2d650b.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 |
|---|
| 53002-3900-1 | 53002390001 | 10 TABLET, FILM COATED in 1 BOTTLE (53002-3900-1) | 2018-10-01 | 0000-00-00 | No | No | Current |
| 53002-3900-2 | 53002390002 | 20 TABLET, FILM COATED in 1 BOTTLE (53002-3900-2) | 2018-10-01 | 0000-00-00 | No | No | Current |
| 53002-3900-3 | 53002390003 | 30 TABLET, FILM COATED in 1 BOTTLE (53002-3900-3) | 2018-10-01 | 0000-00-00 | No | No | Current |