hydroxyzine pamoate
- Product NDC
- 82868-046
- 11-digit product format
- 828680046
- Labeler code
- 82868
- Product ID
- 82868-046_47a6efa2-c61a-654f-e063-6294a90af3d2
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- hydroxyzine pamoate
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Northwind Health Company, LLC
- Application
- ANDA201507
- Marketing category
- ANDA
- Marketing start
- 2024-02-19
- Substance
- HYDROXYZINE PAMOATE
- Active strength
- 50 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 pamoate
- Listing expiration
- 2027-12-31
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 |
|---|
| 82868-046-30 | hydroxyzine pamoate | 30 in 1 BOTTLE, PLASTIC | CAPSULE | 30 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 82868-046 | HYDROXYZINE PAMOATE CAPSULE [NORTHWIND PHARMACEUTICALS, LLC] | 1 | Current NDC, 1 package rows | 20240302_127617c2-9775-3859-e063-6394a90a77cd.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 |
|---|
| 82868-046-30 | 82868004630 | 30 CAPSULE in 1 BOTTLE, PLASTIC (82868-046-30) | 30 capsule | 2024-02-19 | No | No | Historical |