Prescription drug · ANDA
Bisoprolol Fumarate NDC 70095-019
Bisoprolol fumarate 10 mg/1 · Tablet, Film coated · Oral · Sun Pharmaceutical Industries Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70095-019-01 | 7009500190170095001901 | 30 TABLET, FILM COATED in 1 BOTTLE, UNIT-DOSE (70095-019-01)Marketed from Mar 10, 2024 | |
| 70095-019-02 | 7009500190270095001902 | 100 TABLET, FILM COATED in 1 BOTTLE (70095-019-02)Marketed from Mar 10, 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, Film coated
- Route
- Oral
- Labeler
- Sun Pharmaceutical Industries LimitedNDC labeler code 70095
- 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 70095-019_6ce4dc4f-ad08-424e-b90d-400de0b7050aSPL ID 6ce4dc4f-ad08-424e-b90d-400de0b7050aSPL set ID 7556f457-c4d3-49d6-b383-0ade6d489091RxCUI 854901, 854905UNII UR59KN573LUPC 0370095019011, 0370095020017
- 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
N470095001901followed by a unit qualifier and the quantityPackage 70095-0019-01. 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 70095-019
- What is NDC 70095-019?
- 70095-019 is the product NDC for Bisoprolol Fumarate, Bisoprolol fumarate 10 mg/1 tablet, film coated, listed with the FDA by Sun Pharmaceutical Industries 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?
- Sun Pharmaceutical Industries Limited, NDC labeler code 70095. 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 | TabletOral | Harman Finochem Limited | 82638-108 | 82638-0108-0182638-0108-02 |
| 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 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 |
| Bisoprolol Fumarate | Bisoprolol fumarate 10 mg/1 | TabletOral | Harman Finochem Limited | 82638-108 |