hydroxyzine pamoate
- Product NDC
- 71335-1265
- 11-digit product format
- 713351265
- Labeler code
- 71335
- Product ID
- 71335-1265_d9e2251d-75ed-4306-b75c-20e1b145f931
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- hydroxyzine pamoate
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA201507
- Marketing category
- ANDA
- Marketing start
- 2013-06-03
- 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
openFDA Listing Details
- Product ID
- 71335-1265_d9e2251d-75ed-4306-b75c-20e1b145f931
- SPL ID
- d9e2251d-75ed-4306-b75c-20e1b145f931
- Product type
- HUMAN PRESCRIPTION DRUG
- Finished product
- Yes
- Brand name base
- hydroxyzine pamoate
- Generic name
- hydroxyzine pamoate
- Dosage form
- CAPSULE
- Route
- ORAL
- Marketing start
- 2013-06-03
- Marketing category
- ANDA
- Application number
- ANDA201507
- Pharmacologic classes
- Antihistamine [EPC]; Histamine Receptor Antagonists [MoA]
- Listing expiration
- 2026-12-31
openFDA Active Ingredients
| Ingredient | Strength |
|---|
| HYDROXYZINE PAMOATE | 50 mg/1 |
openFDA Harmonized Identifiers
| Field | Values |
|---|
| Unii | M20215MUFR |
| Rxcui | 995278 |
| Spl Set Id | dde576e9-fb6b-40d2-a81f-ebb8656c4c9c |
| Manufacturer Name | Bryant Ranch Prepack |
openFDA Package Details
| Package NDC | Description | Marketing start | Sample |
|---|
| 71335-1265-1 | 30 CAPSULE in 1 BOTTLE (71335-1265-1) | 2019-07-29 | No |
| 71335-1265-2 | 60 CAPSULE in 1 BOTTLE (71335-1265-2) | 2024-05-17 | No |
| 71335-1265-3 | 90 CAPSULE in 1 BOTTLE (71335-1265-3) | 2024-05-17 | No |
| 71335-1265-4 | 8 CAPSULE in 1 BOTTLE (71335-1265-4) | 2024-05-17 | No |
| 71335-1265-5 | 20 CAPSULE in 1 BOTTLE (71335-1265-5) | 2019-06-24 | No |
| 71335-1265-6 | 42 CAPSULE in 1 BOTTLE (71335-1265-6) | 2020-01-06 | No |
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| M20215MUFR | HYDROXYZINE PAMOATE | 10246-75-0 | HYDROXYZINE PAMOATE |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 71335-1265-1 | 71335126501 | 30 CAPSULE in 1 BOTTLE (71335-1265-1) | 30 capsule | 2019-07-29 | No | No | Historical |
| 71335-1265-2 | 71335126502 | 60 CAPSULE in 1 BOTTLE (71335-1265-2) | 60 capsule | 2024-05-17 | No | No | Historical |
| 71335-1265-3 | 71335126503 | 90 CAPSULE in 1 BOTTLE (71335-1265-3) | 90 capsule | 2024-05-17 | No | No | Historical |
| 71335-1265-4 | 71335126504 | 8 CAPSULE in 1 BOTTLE (71335-1265-4) | 8 capsule | 2024-05-17 | No | No | Historical |
| 71335-1265-5 | 71335126505 | 20 CAPSULE in 1 BOTTLE (71335-1265-5) | 20 capsule | 2019-06-24 | No | No | Historical |
| 71335-1265-6 | 71335126506 | 42 CAPSULE in 1 BOTTLE (71335-1265-6) | 42 capsule | 2020-01-06 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Rx only | Bryant Ranch Prepack | 2024-05-17 | HUMAN PRESCRIPTION DRUG LABEL | 6 |