hydroxyzine pamoate
- Product NDC
- 68788-7767
- 11-digit product format
- 687887767
- Labeler code
- 68788
- Product ID
- 68788-7767_c3b04bc3-c236-4ada-ad96-03e0e0327c9d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- hydroxyzine pamoate
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Preferred Pharmaceuticals, Inc.
- Application
- ANDA201507
- Marketing category
- ANDA
- Marketing start
- 2020-08-03
- Substance
- HYDROXYZINE PAMOATE
- 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 pamoate
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| HYDROXYZINE PAMOATE | 25 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | M20215MUFR |
| Rxcui | 995253 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68788-7767-1 | hydroxyzine pamoate | 100 in 1 CONTAINER | CAPSULE | 100 | | 6 |
| 68788-7767-3 | hydroxyzine pamoate | 30 in 1 CONTAINER | CAPSULE | 30 | | 6 |
| 68788-7767-5 | hydroxyzine pamoate | 15 in 1 CONTAINER | CAPSULE | 15 | | 6 |
| 68788-7767-6 | hydroxyzine pamoate | 60 in 1 CONTAINER | CAPSULE | 60 | | 6 |
| 68788-7767-9 | hydroxyzine pamoate | 90 in 1 CONTAINER | CAPSULE | 90 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68788-7767 | HYDROXYZINE PAMOATE CAPSULE [PREFERRED PHARMACEUTICALS, INC.] | 5 | Current NDC, Legacy NDC, 5 package rows | 20240524_2a66117a-fcd4-4094-927c-3a7699ef9660.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 |
|---|
| 68788-7767-1 | 68788776701 | 100 CAPSULE in 1 CONTAINER (68788-7767-1) | 100 capsule | 2020-08-03 | 0000-00-00 | No | No | Current |
| 68788-7767-3 | 68788776703 | 30 CAPSULE in 1 CONTAINER (68788-7767-3) | 30 capsule | 2020-08-03 | 0000-00-00 | No | No | Current |
| 68788-7767-5 | 68788776705 | 15 CAPSULE in 1 CONTAINER (68788-7767-5) | 15 capsule | 2020-08-03 | 0000-00-00 | No | No | Current |
| 68788-7767-6 | 68788776706 | 60 CAPSULE in 1 CONTAINER (68788-7767-6) | 60 capsule | 2020-08-03 | 0000-00-00 | No | No | Current |
| 68788-7767-9 | 68788776709 | 90 CAPSULE in 1 CONTAINER (68788-7767-9) | 90 capsule | 2020-08-03 | 0000-00-00 | No | No | Current |