Bisoprolol Fumarate and Hydrochlorothiazide
- Product NDC
- 72578-113
- 11-digit product format
- 725780113
- Labeler code
- 72578
- Product ID
- 72578-113_550e6ac5-3ece-461f-a9c5-2e4050a5eabb
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- bisoprolol fumarate and hydrochlorothiazide
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Viona Pharmaceuticals Inc
- Application
- ANDA215666
- Marketing category
- ANDA
- Marketing start
- 2023-03-01
- 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 table| Ingredient | Strength |
|---|
| BISOPROLOL FUMARATE | 2.5 mg/1 |
| HYDROCHLOROTHIAZIDE | 6.25 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 0J48LPH2TH, UR59KN573L |
| Rxcui | 854908, 854916, 854919 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 72578-113-01 | Bisoprolol Fumarate and Hydrochlorothiazide | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 3 |
| 72578-113-05 | Bisoprolol Fumarate and Hydrochlorothiazide | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 3 |
| 72578-113-06 | Bisoprolol Fumarate and Hydrochlorothiazide | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 72578-113 | BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [VIONA PHARMACEUTICALS INC] | 3 | Current NDC, 3 package rows | 20240112_57505d73-f2a8-430b-8703-a0a6bb733c7d.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 72578-113-01 | 72578011301 | 100 TABLET, FILM COATED in 1 BOTTLE (72578-113-01) | 2023-03-01 | No | No | Historical |
| 72578-113-05 | 72578011305 | 500 TABLET, FILM COATED in 1 BOTTLE (72578-113-05) | 2023-03-01 | No | No | Historical |
| 72578-113-06 | 72578011306 | 30 TABLET, FILM COATED in 1 BOTTLE (72578-113-06) | 2023-03-01 | No | No | Historical |