hydroxyzine pamoate
- Product NDC
- 43063-406
- 11-digit product format
- 430630406
- Labeler code
- 43063
- Product ID
- 43063-406_4d52a1c6-bbc2-0b02-e063-6294a90afa45
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- hydroxyzine pamoate
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- Application
- ANDA087479
- Marketing category
- ANDA
- Marketing start
- 1981-12-14
- 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 |
|---|
| 43063-406-01 | hydroxyzine pamoate | 100 in 1 BOTTLE, PLASTIC | CAPSULE | 100 | | 43 |
| 43063-406-10 | hydroxyzine pamoate | 10 in 1 BOTTLE, PLASTIC | CAPSULE | 10 | | 43 |
| 43063-406-15 | hydroxyzine pamoate | 15 in 1 BOTTLE, PLASTIC | CAPSULE | 15 | | 43 |
| 43063-406-30 | hydroxyzine pamoate | 30 in 1 BOTTLE, PLASTIC | CAPSULE | 30 | | 43 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| HYDROXYZINE PAMOATE | ACTIVE INGREDIENT | M20215MUFR | HYDROXYZINE PAMOATE CAPSULE [PD-RX PHARMACEUTICALS, INC.] | 17 | |
| HYDROXYZINE | ACTIVE MOIETY | 30S50YM8OG | HYDROXYZINE PAMOATE CAPSULE [PD-RX PHARMACEUTICALS, INC.] | 17 | |
| D&C YELLOW NO. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | HYDROXYZINE PAMOATE CAPSULE [PD-RX PHARMACEUTICALS, INC.] | 17 | |
| FD&C GREEN NO. 3 | INACTIVE INGREDIENT | 3P3ONR6O1S | HYDROXYZINE PAMOATE CAPSULE [PD-RX PHARMACEUTICALS, INC.] | 17 | |
| FD&C YELLOW NO. 6 | INACTIVE INGREDIENT | H77VEI93A8 | HYDROXYZINE PAMOATE CAPSULE [PD-RX PHARMACEUTICALS, INC.] | 17 | |
| GELATIN | INACTIVE INGREDIENT | 2G86QN327L | HYDROXYZINE PAMOATE CAPSULE [PD-RX PHARMACEUTICALS, INC.] | 17 | |
| HYDROXYPROPYL CELLULOSE (TYPE H) | INACTIVE INGREDIENT | RFW2ET671P | HYDROXYZINE PAMOATE CAPSULE [PD-RX PHARMACEUTICALS, INC.] | 17 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | HYDROXYZINE PAMOATE CAPSULE [PD-RX PHARMACEUTICALS, INC.] | 17 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | HYDROXYZINE PAMOATE CAPSULE [PD-RX PHARMACEUTICALS, INC.] | 17 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | HYDROXYZINE PAMOATE CAPSULE [PD-RX PHARMACEUTICALS, INC.] | 17 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | HYDROXYZINE PAMOATE CAPSULE [PD-RX PHARMACEUTICALS, INC.] | 17 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | HYDROXYZINE PAMOATE CAPSULE [PD-RX PHARMACEUTICALS, INC.] | 17 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | HYDROXYZINE PAMOATE CAPSULE [PD-RX PHARMACEUTICALS, INC.] | 17 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | HYDROXYZINE PAMOATE CAPSULE [PD-RX PHARMACEUTICALS, INC.] | 17 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43063-406 | HYDROXYZINE PAMOATE CAPSULE [PD-RX PHARMACEUTICALS, INC.] | 41 | Current NDC, Legacy NDC, 4 package rows | 20240906_98a1c161-5728-4626-a6b0-5414935e4eef.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 |
|---|
| 43063-406-01 | 43063040601 | 100 CAPSULE in 1 BOTTLE, PLASTIC (43063-406-01) | 100 capsule | 2014-07-01 | 0000-00-00 | No | No | Current |
| 43063-406-04 | 43063040604 | 4 CAPSULE in 1 BOTTLE, PLASTIC (43063-406-04) | 4 capsule | 2014-07-01 | 0000-00-00 | No | No | Current |
| 43063-406-10 | 43063040610 | 10 CAPSULE in 1 BOTTLE, PLASTIC (43063-406-10) | 10 capsule | 2014-07-01 | 0000-00-00 | No | No | Current |
| 43063-406-15 | 43063040615 | 15 CAPSULE in 1 BOTTLE, PLASTIC (43063-406-15) | 15 capsule | 2014-07-01 | 0000-00-00 | No | No | Current |
| 43063-406-30 | 43063040630 | 30 CAPSULE in 1 BOTTLE, PLASTIC (43063-406-30) | 30 capsule | 2014-07-01 | 0000-00-00 | No | No | Current |