Hydroxyzine hydrochloride
- Product NDC
- 63187-354
- 11-digit product format
- 631870354
- Labeler code
- 63187
- Product ID
- 63187-354_10a1ea3e-48ca-4dd5-8808-a4be16048c3e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydroxyzine hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Proficient Rx LP
- Application
- ANDA204279
- Marketing category
- ANDA
- Marketing start
- 2014-08-20
- Substance
- HYDROXYZINE DIHYDROCHLORIDE
- Active strength
- 50 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 | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 63187-354-15 | 63187035415 | 15 TABLET in 1 BOTTLE (63187-354-15) | 15 tablet | 2016-08-01 | No | No | Historical |
| 63187-354-30 | 63187035430 | 30 TABLET in 1 BOTTLE (63187-354-30) | 30 tablet | 2016-08-01 | No | No | Historical |
| 63187-354-60 | 63187035460 | 60 TABLET in 1 BOTTLE (63187-354-60) | 60 tablet | 2016-08-01 | No | No | Historical |
| 63187-354-90 | 63187035490 | 90 TABLET in 1 BOTTLE (63187-354-90) | 90 tablet | 2016-08-01 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Rx only | Proficient Rx LP | 2022-06-01 | HUMAN PRESCRIPTION DRUG LABEL | 4 |