Prescription drug · ANDA
Bisoprolol Fumarate NDC 68788-8671
Bisoprolol fumarate 5 mg/1 · Tablet · Oral · Preferred Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68788-8671-1 | 6878886710168788867101 | 100 TABLET in 1 BOTTLE, PLASTIC (68788-8671-1)Marketed from May 21, 2024 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
- Preferred Pharmaceuticals Inc.NDC labeler code 68788
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 078635
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic beta-Antagonists (Mechanism)
- Identifiers
- Product ID 68788-8671_56ee5e1d-4ca1-44de-be60-34563e10c2a0SPL ID 56ee5e1d-4ca1-44de-be60-34563e10c2a0SPL set ID c0e309f3-82c3-4629-b790-fb8538b87369RxCUI 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
N468788867101followed by a unit qualifier and the quantityPackage 68788-8671-01. 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 68788-8671
- What is NDC 68788-8671?
- 68788-8671 is the product NDC for Bisoprolol Fumarate, Bisoprolol fumarate 5 mg/1 tablet, listed with the FDA by Preferred Pharmaceuticals Inc.. It has 1 package NDC, 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?
- Preferred Pharmaceuticals Inc., NDC labeler code 68788. 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 | Harman Finochem Limited | 82638-107 | 82638-0107-0182638-0107-02 |
| Bisoprolol Fumarate | Bisoprolol fumarate 10 mg/1 | TabletOral | Harman Finochem Limited | 82638-108 | 82638-0108-0182638-0108-02 |
| 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 078635
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 | Unichem Pharmaceuticals (USA), Inc. | 29300-126 |
| Bisoprolol Fumarate | Bisoprolol fumarate 10 mg/1 | TabletOral | Unichem Pharmaceuticals (USA), Inc. | 29300-127 |
| Bisoprolol Fumarate | Bisoprolol fumarate 5 mg/1 | TabletOral | American Health Packaging | 60687-679 |
| Bisoprolol Fumarate | Bisoprolol fumarate 5 mg/1 | TabletOral | Proficient Rx LP | 63187-871 |
| Bisoprolol Fumarate | Bisoprolol fumarate 5 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-5173 |
| Bisoprolol Fumarate | Bisoprolol fumarate 10 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2244 |