Hydroxyzine Hydrochloride
- Product NDC
- 70954-912
- 11-digit product format
- 709540912
- Labeler code
- 70954
- Product ID
- 70954-912_43889411-a303-41a1-b03b-1ee46f452c54
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydroxyzine Hydrochloride
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- ANI Pharmaceuticals, Inc.
- Application
- ANDA219648
- Marketing category
- ANDA
- Marketing start
- 2026-01-15
- Substance
- HYDROXYZINE DIHYDROCHLORIDE
- Active strength
- 10 mg/5mL
- 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 | 10 mg/5mL |
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 |
|---|
| 70954-912-10 | Hydroxyzine Hydrochloride | 473 mL in 1 BOTTLE | SOLUTION | 473 | | 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 |
|---|
| 70954-912-10 | 70954091210 | 473 mL in 1 BOTTLE (70954-912-10) | 473 ml | 2026-01-15 | No | No | Historical |