Prescription drug · ANDA
Bisoprolol (bisoprolol fumarate) NDC 52817-270
Bisoprolol fumarate 5 mg/1 · Tablet, Film coated · Oral · TruPharma, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 52817-270-10 | 52817027010 | 100 TABLET, FILM COATED in 1 BOTTLE (52817-270-10)Marketed from Jun 20, 2019 | |
| 52817-270-30 | 52817027030 | 30 TABLET, FILM COATED in 1 BOTTLE (52817-270-30)Marketed from Jun 20, 2019 |
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
- Generic name (nonproprietary)
- bisoprolol fumarate
- Active ingredients
- Bisoprolol fumarate — 5 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- TruPharma, LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 075474
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic beta-Antagonists (Mechanism)
- Identifiers
- Product ID 52817-270_2a9e4180-cb1c-f924-e063-6394a90a60c6SPL ID 2a9e4180-cb1c-f924-e063-6394a90a60c6SPL set ID bba0bc2b-602f-4df1-a761-85bd3c80c7deRxCUI 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
N452817027010followed by a unit qualifier and the quantityPackage 52817-0270-10. 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. It may be used alone or in combination with other antihypertensive agents.
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 075474
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 |
|---|---|---|---|---|
| Bisoprololbisoprolol fumarate | Bisoprolol fumarate 5 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 72162-2177 |
| Bisoprololbisoprolol fumarate | Bisoprolol fumarate 10 mg/1 | Tablet, Film coatedOral | TruPharma, LLC | 52817-271 |
| Bisoprololbisoprolol fumarate | Bisoprolol fumarate 10 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 63629-6907 |
| Bisoprololbisoprolol fumarate | Bisoprolol fumarate 5 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-1678 |