hydroxyzine pamoate
- Product NDC
- 0904-7065
- 11-digit product format
- 009047065
- Labeler code
- 0904
- Product ID
- 0904-7065_52c2f407-7a34-4a45-88ab-d4db6e4dd4c1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- hydroxyzine pamoate
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Major Pharmaceuticals
- Application
- ANDA201507
- Marketing category
- ANDA
- Marketing start
- 2013-06-03
- 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 |
|---|
| 0904-7065-61 | hydroxyzine pamoate | 1 in 1 BLISTER PACK | CAPSULE | 1 | | 6 |
| 0904-7065-61 | hydroxyzine pamoate | 100 in 1 CARTON | CAPSULE | 100 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0904-7065 | HYDROXYZINE PAMOATE CAPSULE [MAJOR PHARMACEUTICALS] | 4 | Current NDC, Legacy NDC, 2 package rows | 20241108_f28f2a1b-8d65-4646-bd99-6e77617f9e1f.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 |
|---|
| 0904-7065-61 | 00904706561 | 100 BLISTER PACK in 1 CARTON (0904-7065-61) / 1 CAPSULE in 1 BLISTER PACK | 100 blister pack | 2013-06-03 | 0000-00-00 | No | No | Current |