Hydroxyzine Hydrochloride
- Product NDC
- 43063-960
- 11-digit product format
- 430630960
- Labeler code
- 43063
- Product ID
- 43063-960_415f3642-ef05-3671-e063-6294a90ab7a7
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- hydroxyzine hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- PD-Rx Pharmaceuticals, 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 |
|---|
| 43063-960-01 | Hydroxyzine Hydrochloride | 100 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 100 | | 22 |
| 43063-960-82 | Hydroxyzine Hydrochloride | 500 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 500 | | 22 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43063-960 | HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 21 | Current NDC, Legacy NDC, 2 package rows | 20241018_1a3e389f-391d-4f37-9e34-ce3c6f5fe8c1.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 |
|---|
| 43063-960-01 | 43063096001 | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-960-01) | 2019-04-01 | 0000-00-00 | No | No | Current |
| 43063-960-82 | 43063096082 | 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-960-82) | 2019-04-01 | 0000-00-00 | No | No | Current |