Prescription drug · ANDA
Bisoprolol fumarate NDC 43547-617
Bisoprolol fumarate 10 mg/1 · Tablet · Oral · Solco Healthcare US, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 43547-617-03 | 43547061703 | 30 TABLET in 1 BOTTLE (43547-617-03)Marketed from Jul 5, 2022 | |
| 43547-617-10 | 43547061710 | 100 TABLET in 1 BOTTLE (43547-617-10)Marketed from Jul 5, 2022 | |
| 43547-617-50 | 43547061750 | 500 TABLET in 1 BOTTLE (43547-617-50)Marketed from Jul 5, 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 — 10 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Solco Healthcare US, LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 217368
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic beta-Antagonists (Mechanism)
- Identifiers
- Product ID 43547-617_e8b6cea1-8a7f-4255-8a24-ff96d6ceece2SPL ID e8b6cea1-8a7f-4255-8a24-ff96d6ceece2SPL set ID 084308e4-3b8b-40d6-acbf-d775772a8a73RxCUI 854901, 854905UNII UR59KN573LUPC 0343547616038, 0343547617035
- 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
N443547061703followed by a unit qualifier and the quantityPackage 43547-0617-03. 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 217368
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 5 mg/1 | TabletOral | Solco Healthcare US, LLC | 43547-616 |
- openFDA data updated
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