Prescription drug · ANDA
Bisoprolol Fumarate NDC 50268-127
Bisoprolol fumarate 5 mg/1 · Tablet, Film coated · Oral · AvPAK
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50268-127-15 | 50268012715 | 50 BLISTER PACK in 1 BOX (50268-127-15) / 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-127-11)Marketed from Jan 10, 2022 |
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, Film coated
- Route
- Oral
- Labeler
- AvPAK
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 077910
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic beta-Antagonists (Mechanism)
- Identifiers
- Product ID 50268-127_0e85a1ff-1540-187e-e063-6394a90a3b1eSPL ID 0e85a1ff-1540-187e-e063-6394a90a3b1eSPL set ID d540ef44-9016-9d66-e053-2a95a90a16a9RxCUI 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
N450268012715followed by a unit qualifier and the quantityPackage 50268-0127-15. 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
Current FDA label (SPL), effective .
Indications (excerpt from the label)
INDICATIONS AND USAGE Bisoprolol fumarate tablets are indicated in the management of hypertension. They may be used alone or in combination with other antihypertensive agents.
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 077910
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 | Tablet, Film coatedOral | NorthStar Rx LLC | 16714-530 |
| Bisoprolol Fumarate | Bisoprolol fumarate 5 mg/1 | Tablet, Film coatedOral | NorthStar Rx LLC | 16714-529 |
| Bisoprolol Fumarate | Bisoprolol fumarate 5 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 65862-086 |
| Bisoprolol Fumarate | Bisoprolol fumarate 10 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 65862-087 |