Hydroxyzine Hydrochloride
- Product NDC
- 71335-2451
- 11-digit product format
- 713352451
- Labeler code
- 71335
- Product ID
- 71335-2451_897a39b6-65b1-4e52-85e9-2650d23a4dc0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydroxyzine Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA040786
- Marketing category
- ANDA
- Marketing start
- 2012-07-24
- 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 | 995258 |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 71335-2451-1 | 71335245101 | 30 TABLET, FILM COATED in 1 BOTTLE (71335-2451-1) | 2024-08-20 | No | No | Historical |
| 71335-2451-2 | 71335245102 | 60 TABLET, FILM COATED in 1 BOTTLE (71335-2451-2) | 2024-08-20 | No | No | Historical |
| 71335-2451-3 | 71335245103 | 20 TABLET, FILM COATED in 1 BOTTLE (71335-2451-3) | 2024-08-20 | No | No | Historical |
| 71335-2451-4 | 71335245104 | 100 TABLET, FILM COATED in 1 BOTTLE (71335-2451-4) | 2024-08-20 | No | No | Historical |
| 71335-2451-5 | 71335245105 | 15 TABLET, FILM COATED in 1 BOTTLE (71335-2451-5) | 2024-08-20 | No | No | Historical |
| 71335-2451-6 | 71335245106 | 90 TABLET, FILM COATED in 1 BOTTLE (71335-2451-6) | 2024-08-20 | No | No | Historical |
| 71335-2451-7 | 71335245107 | 19 TABLET, FILM COATED in 1 BOTTLE (71335-2451-7) | 2024-08-20 | No | No | Historical |
| 71335-2451-8 | 71335245108 | 10 TABLET, FILM COATED in 1 BOTTLE (71335-2451-8) | 2024-08-20 | No | No | Historical |