Hydroxyzine pamoate
- Product NDC
- 62135-816
- 11-digit product format
- 621350816
- Labeler code
- 62135
- Product ID
- 62135-816_459cbe6c-6bd5-a598-e063-6394a90ac077
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydroxyzine pamoate
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Chartwell RX, LLC
- 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, 995278 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 62135-816-12 | Hydroxyzine pamoate | 120 in 1 BOTTLE | CAPSULE | 120 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 62135-816 | HYDROXYZINE PAMOATE CAPSULE [CHARTWELL RX, LLC] | 1 | Current NDC, 1 package rows | 20240208_abe7280a-1f6a-404b-9874-7710121e2090.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 |
|---|
| 62135-816-12 | 62135081612 | 120 CAPSULE in 1 BOTTLE (62135-816-12) | 120 capsule | 2024-02-06 | No | No | Historical |