hydroxyzine pamoate
- Product NDC
- 70518-0209
- 11-digit product format
- 705180209
- Labeler code
- 70518
- Product ID
- 70518-0209_47e4f8ab-3450-47af-e063-6294a90acd5d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- hydroxyzine pamoate
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA087479
- Marketing category
- ANDA
- Marketing start
- 2017-02-09
- Substance
- HYDROXYZINE PAMOATE
- Active strength
- 25 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 | 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 |
|---|
| 70518-0209-0 | hydroxyzine pamoate | 30 in 1 BOTTLE, PLASTIC | CAPSULE | 30 | | 20 |
| 70518-0209-1 | hydroxyzine pamoate | 30 in 1 BLISTER PACK | CAPSULE | 30 | | 20 |
| 70518-0209-2 | hydroxyzine pamoate | 10 in 1 BOTTLE, PLASTIC | CAPSULE | 10 | | 20 |
| 70518-0209-3 | hydroxyzine pamoate | 100 in 1 BOTTLE | CAPSULE | 100 | | 20 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70518-0209 | HYDROXYZINE PAMOATE CAPSULE [REMEDYREPACK INC.] | 17 | Current NDC, Legacy NDC, 4 package rows | 20250425_2e59dc14-7e17-4663-bc1f-7ee8e104dbfa.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 |
|---|
| 70518-0209-0 | 70518020900 | 30 CAPSULE in 1 BOTTLE, PLASTIC (70518-0209-0) | 30 capsule | 2017-02-09 | 0000-00-00 | No | No | Current |
| 70518-0209-1 | 70518020901 | 30 CAPSULE in 1 BLISTER PACK (70518-0209-1) | 30 capsule | 2017-02-16 | 0000-00-00 | No | No | Current |
| 70518-0209-2 | 70518020902 | 10 in 1 BOTTLE, PLASTIC | | | | | | Historical |
| 70518-0209-3 | 70518020903 | 100 CAPSULE in 1 BOTTLE (70518-0209-3) | 100 capsule | 2020-05-13 | 0000-00-00 | No | No | Current |