Prescription drug · ANDA
Bisoprolol Fumarate NDC 82638-107
Bisoprolol fumarate 5 mg/1 · Tablet · Oral · Harman Finochem Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 82638-107-01 | 82638010701 | 30 TABLET in 1 BOTTLE (82638-107-01)Marketed from Jul 30, 2024 | |
| 82638-107-02 | 82638010702 | 100 TABLET in 1 BOTTLE (82638-107-02)Marketed from Jul 30, 2024 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Bisoprolol Fumarate
- Generic name (nonproprietary)
- bisoprolol fumarate
- Active ingredients
- Bisoprolol fumarate — 5 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Harman Finochem Limited
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 217617
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic beta-Antagonists (Mechanism)
- Identifiers
- Product ID 82638-107_189028b6-aef4-6dd5-e063-6394a90afeedSPL ID 189028b6-aef4-6dd5-e063-6394a90afeedSPL set ID 65da2d2e-cce8-4bf6-a12d-3565b4b6b7c8RxCUI 854901, 854905UNII UR59KN573L
- Pharmacologic class
- beta-Adrenergic Blocker
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N482638010701followed by a unit qualifier and the quantityPackage 82638-0107-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Label details couldn’t be retrieved right now. Open the label on DailyMed.
Other NDCs under ANDA 217617
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Bisoprolol Fumarate | Bisoprolol fumarate 10 mg/1 | TabletOral | Harman Finochem Limited | 82638-108 |
| Bisoprolol Fumarate | Bisoprolol fumarate 5 mg/1 | Tablet, Film coatedOral | PD-Rx Pharmaceuticals, Inc. | 72789-392 |
| Bisoprolol Fumarate | Bisoprolol fumarate 10 mg/1 | Tablet, Film coatedOral | PD-Rx Pharmaceuticals, Inc. | 72789-395 |
| Bisoprolol Fumarate | Bisoprolol fumarate 10 mg/1 | Tablet, Film coatedOral | Sun Pharmaceutical Industries Limited | 70095-019 |
| Bisoprolol Fumarate | Bisoprolol fumarate 5 mg/1 | Tablet, Film coatedOral | Sun Pharmaceutical Industries Limited | 70095-020 |