HYDROXYZINE HYDROCHLORIDE
- Product NDC
- 71335-2636
- 11-digit product format
- 713352636
- Labeler code
- 71335
- Product ID
- 71335-2636_f3f81841-db62-4a69-b56c-466088cfa950
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- hydroxyzine hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA217652
- Marketing category
- ANDA
- Marketing start
- 2023-08-22
- Substance
- HYDROXYZINE HYDROCHLORIDE
- Active strength
- 10 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
- 71335-2636_f3f81841-db62-4a69-b56c-466088cfa950
- Product type
- HUMAN PRESCRIPTION DRUG
- Finished product
- Yes
- Brand name base
- HYDROXYZINE HYDROCHLORIDE
- Generic name
- hydroxyzine hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Marketing start
- 2023-08-22
- Marketing category
- ANDA
- Application number
- ANDA217652
- Pharmacologic classes
- Antihistamine [EPC]; Histamine Receptor Antagonists [MoA]
- Listing expiration
- 2026-12-31
openFDA Active Ingredients
| Ingredient | Strength |
|---|
| HYDROXYZINE HYDROCHLORIDE | 10 mg/1 |
openFDA Harmonized Identifiers
| Field | Values |
|---|
| Unii | 76755771U3 |
| Rxcui | 995218 |
| Spl Set Id | 6577589f-1a80-41d8-847a-70c3f38d8dc0 |
| Manufacturer Name | Bryant Ranch Prepack |
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| 76755771U3 | HYDROXYZINE HYDROCHLORIDE | 2192-20-3 | HYDROXYZINE HYDROCHLORIDE |
Packages
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 71335-2636-1 | 71335263601 | 30 TABLET, FILM COATED in 1 BOTTLE (71335-2636-1) | 2025-06-02 | No | No | Current |
| 71335-2636-2 | 71335263602 | 100 TABLET, FILM COATED in 1 BOTTLE (71335-2636-2) | 2025-06-02 | No | No | Current |
| 71335-2636-3 | 71335263603 | 20 TABLET, FILM COATED in 1 BOTTLE (71335-2636-3) | 2025-06-02 | No | No | Current |
| 71335-2636-4 | 71335263604 | 90 TABLET, FILM COATED in 1 BOTTLE (71335-2636-4) | 2025-06-02 | No | No | Current |
| 71335-2636-5 | 71335263605 | 15 TABLET, FILM COATED in 1 BOTTLE (71335-2636-5) | 2025-06-02 | No | No | Current |
| 71335-2636-6 | 71335263606 | 60 TABLET, FILM COATED in 1 BOTTLE (71335-2636-6) | 2025-06-02 | No | No | Current |
| 71335-2636-7 | 71335263607 | 120 TABLET, FILM COATED in 1 BOTTLE (71335-2636-7) | 2025-06-02 | No | No | Current |
| 71335-2636-8 | 71335263608 | 10 TABLET, FILM COATED in 1 BOTTLE (71335-2636-8) | 2025-06-02 | No | No | Current |