HYDROXYZINE HYDROCHLORIDE
- Product NDC
- 70518-4141
- 11-digit product format
- 705184141
- Labeler code
- 70518
- Product ID
- 70518-4141_3a0b52a9-eb8c-08fe-e063-6394a90a6f9f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- hydroxyzine hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA217652
- Marketing category
- ANDA
- Marketing start
- 2024-07-16
- 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 |
|---|
| 70518-4141-0 | 70518414100 | 30 TABLET, FILM COATED in 1 BLISTER PACK (70518-4141-0) | 2024-07-16 | No | No | Historical |
| 70518-4141-1 | 70518414101 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4141-1) | 2025-03-26 | No | No | Historical |
| 70518-4141-2 | 70518414102 | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4141-2) | 2025-07-15 | No | No | Historical |