HydrOXYzine Hydrochloride
- Product NDC
- 68071-3450
- 11-digit product format
- 680713450
- Labeler code
- 68071
- Product ID
- 68071-3450_2d674f1c-812e-5feb-e063-6294a90a2aeb
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- HydrOXYzine Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- NuCare Pharmaceuticals,Inc.
- Application
- ANDA040840
- Marketing category
- ANDA
- Marketing start
- 2009-11-11
- 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 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68071-3450-4 | HydrOXYzine Hydrochloride | 4 in 1 BOTTLE | TABLET | 4 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68071-3450 | HYDROXYZINE HYDROCHLORIDE TABLET [NUCARE PHARMACEUTICALS,INC.] | 2 | Current NDC, 1 package rows | 20250207_ffd33207-3f35-3486-e053-6394a90ac0ae.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 |
|---|
| 68071-3450-4 | 68071345004 | 4 TABLET in 1 BOTTLE (68071-3450-4) | 4 tablet | 2023-07-06 | No | No | Historical |