Prescription drug · ANDA
Bisoprolol Fumarate NDC 82638-108
Bisoprolol fumarate 10 mg/1 · Tablet · Oral · Harman Finochem Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 82638-108-01 | 8263801080182638010801 | 30 TABLET in 1 BOTTLE (82638-108-01)Marketed from Jul 30, 2024 | |
| 82638-108-02 | 8263801080282638010802 | 100 TABLET in 1 BOTTLE (82638-108-02)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 — 10 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Harman Finochem LimitedNDC labeler code 82638
- 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 82638-108_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
N482638010801followed by a unit qualifier and the quantityPackage 82638-0108-01. 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
Current FDA label (SPL), effective .
Indications (excerpt from the label)
INDICATIONS AND USAGE Bisoprolol fumarate is 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.
About NDC 82638-108
- What is NDC 82638-108?
- 82638-108 is the product NDC for Bisoprolol Fumarate, Bisoprolol fumarate 10 mg/1 tablet, listed with the FDA by Harman Finochem Limited. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Bisoprolol Fumarate.
- What is the active ingredient?
- Bisoprolol fumarate.
- Who is the labeler?
- Harman Finochem Limited, NDC labeler code 82638. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Bisoprolol Fumarate?
- 40 other product NDCs are listed under this name. See all Bisoprolol Fumarate NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Bisoprolol Fumarate products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Bisoprolol Fumarate | Bisoprolol fumarate 5 mg/1 | Tablet, Film coatedOral | Rising Pharma Holdings, Inc. | 64980-709 | 64980-0709-0164980-0709-03 |
| Bisoprolol Fumarate | Bisoprolol fumarate 10 mg/1 | Tablet, Film coatedOral | Rising Pharma Holdings, Inc. | 64980-710 | 64980-0710-0164980-0710-03 |
| Bisoprolol Fumarate | Bisoprolol fumarate 2.5 mg/1 | Tablet, Film coatedOral | TruPharma LLC | 52817-268 | 52817-0268-30 |
| Bisoprolol Fumarate | Bisoprolol fumarate 2.5 mg/1 | Tablet, Film coatedOral | Advagen Pharma Ltd | 72888-233 | 72888-0233-01 |
| Bisoprolol fumarate | Bisoprolol fumarate 5 mg/1 | TabletOral | Natco Pharma USA LLC | 69339-236 | 69339-0236-0169339-0236-03 |
| Bisoprolol fumarate | Bisoprolol fumarate 10 mg/1 | TabletOral | Natco Pharma USA LLC | 69339-237 | 69339-0237-0169339-0237-03 |
| Bisoprolol Fumarate | Bisoprolol fumarate 5 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-8671 | 68788-8671-01 |
| Bisoprolol Fumarate | Bisoprolol fumarate 5 mg/1 | TabletOral | Harman Finochem Limited | 82638-107 | 82638-0107-0182638-0107-02 |
| Bisoprolol Fumarate | Bisoprolol fumarate 10 mg/1 | Tablet, Film coatedOral | Sun Pharmaceutical Industries Limited | 70095-019 | 70095-0019-0170095-0019-02 |
| Bisoprolol Fumarate | Bisoprolol fumarate 5 mg/1 | Tablet, Film coatedOral | Sun Pharmaceutical Industries Limited | 70095-020 | 70095-0020-0170095-0020-02 |
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 | 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 |
| 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 5 mg/1 | TabletOral | Harman Finochem Limited | 82638-107 |