HYDROXYZINE HYDROCHLORIDE
- Product NDC
- 10135-811
- 11-digit product format
- 101350811
- Labeler code
- 10135
- Product ID
- 10135-811_31a907fc-2be0-1219-e063-6294a90ac00f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- hydroxyzine hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Marlex Pharmaceuticals, Inc.
- Application
- ANDA207121
- Marketing category
- ANDA
- Marketing start
- 2025-03-01
- 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
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| 76755771U3 | HYDROXYZINE HYDROCHLORIDE | 2192-20-3 | hydroxyzine hydrochloride |
Packages
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 10135-811-01 | 10135081101 | 100 TABLET, FILM COATED in 1 BOTTLE (10135-811-01) | 2025-03-01 | No | No | Historical |
| 10135-811-10 | 10135081110 | 1000 TABLET, FILM COATED in 1 BOTTLE (10135-811-10) | 2025-03-01 | No | No | Historical |