HydrOXYzine Hydrochloride
- Product NDC
- 16714-082
- 11-digit product format
- 167140082
- Labeler code
- 16714
- Product ID
- 16714-082_1a8febc0-9d51-4026-8ea6-6cba69e841c5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- HydrOXYzine Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Northstar RxLLC
- 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- HydrOXYzine Hydrochloride
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| HYDROXYZINE DIHYDROCHLORIDE | 25 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 76755771U3 |
| Rxcui | 995218, 995258, 995281 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 16714-082-10 | HydrOXYzine Hydrochloride | 100 in 1 BOTTLE | TABLET | 100 | | 19 |
| 16714-082-11 | HydrOXYzine Hydrochloride | 500 in 1 BOTTLE | TABLET | 500 | | 19 |
| 16714-082-12 | HydrOXYzine Hydrochloride | 1000 in 1 BOTTLE | TABLET | 1000 | | 19 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 16714-082 | HYDROXYZINE HYDROCHLORIDE TABLET [NORTHSTAR RXLLC] | 18 | Current NDC, Legacy NDC, 3 package rows | 20250206_8e5fce17-936e-46ea-a969-518c952c2091.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 16714-082-10 | 16714008210 | 100 TABLET in 1 BOTTLE (16714-082-10) | 100 tablet | 2009-11-11 | 0000-00-00 | No | No | Current |
| 16714-082-11 | 16714008211 | 500 TABLET in 1 BOTTLE (16714-082-11) | 500 tablet | 2009-11-11 | 0000-00-00 | No | No | Current |
| 16714-082-12 | 16714008212 | 1000 TABLET in 1 BOTTLE (16714-082-12) | 1000 tablet | 2009-11-11 | 0000-00-00 | No | No | Current |