hydroxyzine pamoate
- Product NDC
- 68071-3583
- 11-digit product format
- 680713583
- Labeler code
- 68071
- Product ID
- 68071-3583_1302e0e1-cff5-2a38-e063-6294a90ae178
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- hydroxyzine pamoate
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- NuCare Pharmaceuticals,Inc.
- Application
- ANDA201507
- Marketing category
- ANDA
- Marketing start
- 2013-06-03
- Substance
- HYDROXYZINE PAMOATE
- 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 pamoate
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| HYDROXYZINE PAMOATE | 50 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | M20215MUFR |
| Rxcui | 995278 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68071-3583-9 | hydroxyzine pamoate | 90 in 1 CONTAINER | CAPSULE | 90 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68071-3583 | HYDROXYZINE PAMOATE CAPSULE [NUCARE PHARMACEUTICALS,INC.] | 1 | Current NDC, 1 package rows | 20240308_1302c511-eb25-5818-e063-6394a90a9225.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 |
|---|
| 68071-3583-9 | 68071358309 | 90 CAPSULE in 1 CONTAINER (68071-3583-9) | 90 capsule | 2024-03-06 | No | No | Current |