Hydroxyzine Hydrochloride
- Product NDC
- 62135-546
- 11-digit product format
- 621350546
- Labeler code
- 62135
- Product ID
- 62135-546_258a2adf-df42-7a34-e063-6294a90a84ca
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydroxyzine Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Chartwell RX, LLC
- Application
- ANDA040804
- Marketing category
- ANDA
- Marketing start
- 2008-06-30
- Substance
- HYDROXYZINE DIHYDROCHLORIDE
- Active strength
- 25 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 | 25 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 |
|---|
| 62135-546-05 | Hydroxyzine Hydrochloride | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 2 |
| 62135-546-12 | Hydroxyzine Hydrochloride | 120 in 1 BOTTLE | TABLET, FILM COATED | 120 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 62135-546 | HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [CHARTWELL RX, LLC] | 2 | Current NDC, 2 package rows | 20241030_934afb42-fee8-415b-8090-2265bb299afe.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 62135-546-05 | 62135054605 | 500 TABLET, FILM COATED in 1 BOTTLE (62135-546-05) | 2023-06-28 | No | No | Historical |
| 62135-546-12 | 62135054612 | 120 TABLET, FILM COATED in 1 BOTTLE (62135-546-12) | 2023-06-28 | No | No | Historical |