Hydroxyzine Hydrochloride
- Product NDC
- 0121-1034
- 11-digit product format
- 001211034
- Labeler code
- 0121
- Product ID
- 0121-1034_44c48714-8f0c-4628-9783-ff32360b457d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- hydroxyzine hydrochloride
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- PAI Holdings, LLC dba PAI Pharma
- Application
- ANDA040391
- Marketing category
- ANDA
- Marketing start
- 2002-04-10
- 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 |
|---|
| 0121-1034-16 | Hydroxyzine Hydrochloride | 473 mL in 1 BOTTLE | SOLUTION | 473 | | 10 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0121-1034 | HYDROXYZINE HYDROCHLORIDE SOLUTION [PAI HOLDINGS, LLC DBA PAI PHARMA] | 9 | Current NDC, 1 package rows | 20241115_2a343906-0bea-4bd8-bd35-c3f199d9b266.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 0121-1034-16 | 00121103416 | 473 mL in 1 BOTTLE (0121-1034-16) | 473 ml | 2024-11-14 | No | No | Current |