Bisoprolol Fumarate and Hydrochlorothiazide
- Product NDC
- 71335-2616
- 11-digit product format
- 713352616
- Labeler code
- 71335
- Product ID
- 71335-2616_151c5d77-5e7e-4973-9a18-0a4db787b49b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Bisoprolol Fumarate and Hydrochlorothiazide
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA215995
- Marketing category
- ANDA
- Marketing start
- 2022-01-26
- Substance
- BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE
- Active strength
- 2.5; 6.25 mg/1; mg/1
- Pharmacologic classes
- Adrenergic beta-Antagonists [MoA], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS], beta-Adrenergic Blocker [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data
- Finished product
- Yes
- Brand name base
- Bisoprolol Fumarate and Hydrochlorothiazide
- Listing expiration
- 2026-12-31
Active Ingredients
| Ingredient | Strength |
|---|
| BISOPROLOL FUMARATE | 2.5 mg/1 |
| HYDROCHLOROTHIAZIDE | 6.25 mg/1 |
Harmonized Identifiers
| Field | Values |
|---|
| Unii | UR59KN573L, 0J48LPH2TH |
| Rxcui | 854916 |
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| UR59KN573L | BISOPROLOL FUMARATE | 104344-23-2 | BISOPROLOL FUMARATE |
| 0J48LPH2TH | HYDROCHLOROTHIAZIDE | 58-93-5 | HYDROCHLOROTHIAZIDE |
Packages
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 71335-2616-1 | 71335261601 | 100 TABLET, FILM COATED in 1 BOTTLE (71335-2616-1) | 2025-05-29 | No | No | Current |
| 71335-2616-2 | 71335261602 | 30 TABLET, FILM COATED in 1 BOTTLE (71335-2616-2) | 2025-05-29 | No | No | Current |
| 71335-2616-3 | 71335261603 | 90 TABLET, FILM COATED in 1 BOTTLE (71335-2616-3) | 2025-05-29 | No | No | Current |