Bisoprolol Fumarate
- Product NDC
- 70954-455
- 11-digit product format
- 709540455
- Labeler code
- 70954
- Product ID
- 70954-455_6517d564-ea55-4084-a8ab-34fea548c24e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Bisoprolol Fumarate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Novitium Pharma LLC
- Application
- ANDA215563
- Marketing category
- ANDA
- Marketing start
- 2021-10-29
- Substance
- BISOPROLOL FUMARATE
- Active strength
- 5 mg/1
- Pharmacologic classes
- Adrenergic beta-Antagonists [MoA], 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
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| BISOPROLOL FUMARATE | 5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | UR59KN573L |
| Rxcui | 854901, 854905 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70954-455-10 | Bisoprolol Fumarate | 30 in 1 BOTTLE | TABLET | 30 | | 1 |
| 70954-455-20 | Bisoprolol Fumarate | 100 in 1 BOTTLE | TABLET | 100 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70954-455 | BISOPROLOL FUMARATE TABLET [NOVITIUM PHARMA LLC] | 1 | Current NDC, Legacy NDC, 2 package rows | 20211106_6517d564-ea55-4084-a8ab-34fea548c24e.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 70954-455-10 | 70954045510 | 30 TABLET in 1 BOTTLE (70954-455-10) | 30 tablet | 2021-10-29 | 0000-00-00 | No | No | Current |
| 70954-455-20 | 70954045520 | 100 TABLET in 1 BOTTLE (70954-455-20) | 100 tablet | 2021-10-29 | 0000-00-00 | No | No | Current |