hydroxyzine pamoate
- Product NDC
- 71335-1325
- 11-digit product format
- 713351325
- Labeler code
- 71335
- Product ID
- 71335-1325_fc20de76-1328-4c44-a143-d25ec5845187
- 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
- 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
openFDA Listing Details
- Product ID
- 71335-1325_fc20de76-1328-4c44-a143-d25ec5845187
- SPL ID
- fc20de76-1328-4c44-a143-d25ec5845187
- 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 | 25 mg/1 |
openFDA Harmonized Identifiers
| Field | Values |
|---|
| Unii | M20215MUFR |
| Rxcui | 995253 |
| Spl Set Id | 7996dfa3-7f34-4d20-acaa-7f6fc021fc80 |
| Manufacturer Name | Bryant Ranch Prepack |
openFDA Package Details
| Package NDC | Description | Marketing start | Sample |
|---|
| 71335-1325-1 | 20 CAPSULE in 1 BOTTLE (71335-1325-1) | 2019-08-28 | No |
| 71335-1325-2 | 30 CAPSULE in 1 BOTTLE (71335-1325-2) | 2019-08-28 | No |
| 71335-1325-3 | 100 CAPSULE in 1 BOTTLE (71335-1325-3) | 2022-09-19 | No |
| 71335-1325-4 | 10 CAPSULE in 1 BOTTLE (71335-1325-4) | 2022-09-19 | No |
| 71335-1325-5 | 15 CAPSULE in 1 BOTTLE (71335-1325-5) | 2022-09-19 | No |
| 71335-1325-6 | 60 CAPSULE in 1 BOTTLE (71335-1325-6) | 2021-12-22 | No |
| 71335-1325-7 | 90 CAPSULE in 1 BOTTLE (71335-1325-7) | 2021-09-30 | No |
| 71335-1325-8 | 120 CAPSULE in 1 BOTTLE (71335-1325-8) | 2022-09-19 | No |
| 71335-1325-9 | 42 CAPSULE in 1 BOTTLE (71335-1325-9) | 2022-09-19 | 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 |
|---|
| 71335-1325-1 | 71335132501 | 20 CAPSULE in 1 BOTTLE (71335-1325-1) | 20 capsule | 2019-08-28 | No | No | Historical |
| 71335-1325-2 | 71335132502 | 30 CAPSULE in 1 BOTTLE (71335-1325-2) | 30 capsule | 2019-08-28 | No | No | Historical |
| 71335-1325-3 | 71335132503 | 100 CAPSULE in 1 BOTTLE (71335-1325-3) | 100 capsule | 2022-09-19 | No | No | Historical |
| 71335-1325-4 | 71335132504 | 10 CAPSULE in 1 BOTTLE (71335-1325-4) | 10 capsule | 2022-09-19 | No | No | Historical |
| 71335-1325-5 | 71335132505 | 15 CAPSULE in 1 BOTTLE (71335-1325-5) | 15 capsule | 2022-09-19 | No | No | Historical |
| 71335-1325-6 | 71335132506 | 60 CAPSULE in 1 BOTTLE (71335-1325-6) | 60 capsule | 2021-12-22 | No | No | Historical |
| 71335-1325-7 | 71335132507 | 90 CAPSULE in 1 BOTTLE (71335-1325-7) | 90 capsule | 2021-09-30 | No | No | Historical |
| 71335-1325-8 | 71335132508 | 120 CAPSULE in 1 BOTTLE (71335-1325-8) | 120 capsule | 2022-09-19 | No | No | Historical |
| 71335-1325-9 | 71335132509 | 42 CAPSULE in 1 BOTTLE (71335-1325-9) | 42 capsule | 2022-09-19 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Rx only | Bryant Ranch Prepack | 2025-09-23 | HUMAN PRESCRIPTION DRUG LABEL | 106 |
| Rx only | Bryant Ranch Prepack | 2024-05-24 | HUMAN PRESCRIPTION DRUG LABEL | 105 |