Hydroxyzine hydrochloride
- Product NDC
- 72789-378
- 11-digit product format
- 727890378
- Labeler code
- 72789
- Product ID
- 72789-378_3807de87-ff3b-f62b-e063-6294a90aca9f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydroxyzine hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- Application
- ANDA204279
- Marketing category
- ANDA
- Marketing start
- 2014-08-20
- Substance
- HYDROXYZINE DIHYDROCHLORIDE
- Active strength
- 50 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 | 50 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 76755771U3 |
| Rxcui | 995281 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 72789-378-30 | Hydroxyzine hydrochloride | 30 in 1 BOTTLE, PLASTIC | TABLET | 30 | | 23 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 72789-378 | HYDROXYZINE HYDROCHLORIDE TABLET [PD-RX PHARMACEUTICALS, INC.] | 21 | Current NDC, 1 package rows | 20240802_44c63e67-a9e0-4a4f-b34e-2ca60a981766.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 |
|---|
| 72789-378-30 | 72789037830 | 30 TABLET in 1 BOTTLE, PLASTIC (72789-378-30) | 30 tablet | 2024-02-02 | No | No | Current |