hydroxyzine pamoate
- Product NDC
- 70518-4463
- 11-digit product format
- 705184463
- Labeler code
- 70518
- Product ID
- 70518-4463_3e8556f2-6164-e13b-e063-6294a90afae3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- hydroxyzine pamoate
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA201507
- Marketing category
- ANDA
- Marketing start
- 2025-08-30
- 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 |
|---|
| 70518-4463-0 | hydroxyzine pamoate | 21 in 1 BLISTER PACK | CAPSULE | 21 | | 2 |
| 70518-4463-1 | hydroxyzine pamoate | 30 in 1 BLISTER PACK | CAPSULE | 30 | | 2 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 70518-4463-0 | 70518446300 | 21 CAPSULE in 1 BLISTER PACK (70518-4463-0) | 21 capsule | 2025-08-30 | No | No | Historical |
| 70518-4463-1 | 70518446301 | 30 CAPSULE in 1 BLISTER PACK (70518-4463-1) | 30 capsule | 2025-09-11 | No | No | Historical |