Bisoprolol Fumarate
- Product NDC
- 82638-108
- 11-digit product format
- 826380108
- Labeler code
- 82638
- Product ID
- 82638-108_189028b6-aef4-6dd5-e063-6394a90afeed
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Bisoprolol Fumarate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Harman Finochem Limited
- Application
- ANDA217617
- Marketing category
- ANDA
- Marketing start
- 2024-05-12
- Substance
- BISOPROLOL FUMARATE
- Active strength
- 10 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 | 10 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 |
|---|
| 82638-108-01 | Bisoprolol Fumarate | 30 in 1 BOTTLE | TABLET | 30 | | 3 |
| 82638-108-02 | Bisoprolol Fumarate | 100 in 1 BOTTLE | TABLET | 100 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 82638-108 | BISOPROLOL FUMARATE TABLET [HARMAN FINOCHEM LIMITED] | 3 | Current NDC, 2 package rows | 20240517_65da2d2e-cce8-4bf6-a12d-3565b4b6b7c8.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 82638-108-01 | 82638010801 | 30 TABLET in 1 BOTTLE (82638-108-01) | 30 tablet | 2024-07-30 | No | No | Historical |
| 82638-108-02 | 82638010802 | 100 TABLET in 1 BOTTLE (82638-108-02) | 100 tablet | 2024-07-30 | No | No | Historical |