HYDROXYZINE HYDROCHLORIDE
- Product NDC
- 68999-050
- 11-digit product format
- 689990050
- Labeler code
- 68999
- Product ID
- 68999-050_4356ec2d-ecb8-1aed-e063-6394a90ad74e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- HYDROXYZINE HYDROCHLORIDE
- Dosage form
- SYRUP
- Route
- ORAL
- Labeler
- Chartwell Governmental & Specialty RX, LLC.
- Application
- ANDA087294
- Marketing category
- ANDA
- Marketing start
- 1982-04-12
- Substance
- HYDROXYZINE DIHYDROCHLORIDE
- Active strength
- 50 mg/25mL
- 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 | 50 mg/25mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 76755771U3 |
| Rxcui | 995241 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68999-050-24 | HYDROXYZINE HYDROCHLORIDE | 2 in 1 BOX | SYRUP | 2 | | 1 |
| 68999-050-24 | HYDROXYZINE HYDROCHLORIDE | 10 in 1 TRAY | SYRUP | 10 | | 1 |
| 68999-050-52 | HYDROXYZINE HYDROCHLORIDE | 25 mL in 1 CUP | SYRUP | 25 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 68999-050-24 | 68999005024 | 2 TRAY in 1 BOX (68999-050-24) / 10 CUP in 1 TRAY / 25 mL in 1 CUP (68999-050-52) | 2 tray | 2025-10-31 | No | No | Historical |
| 68999-050-52 | 68999005052 | 25 mL in 1 CUP | 25 ml | | | | Historical |