Prescription drug · ANDA
Bisoprolol Fumarate NDC 29300-127
Bisoprolol fumarate 10 mg/1 · Tablet · Oral · Unichem Pharmaceuticals (USA), Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 29300-127-01 | 2930001270129300012701 | 100 TABLET in 1 BOTTLE, PLASTIC (29300-127-01)Marketed from Sep 21, 2009 | |
| 29300-127-05 | 2930001270529300012705 | 500 TABLET in 1 BOTTLE, PLASTIC (29300-127-05)Marketed from Aug 19, 2016 | |
| 29300-127-13 | 2930001271329300012713 | 30 TABLET in 1 BOTTLE, PLASTIC (29300-127-13)Marketed from Sep 21, 2009 |
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
- Unichem Pharmaceuticals (USA), Inc.NDC labeler code 29300
- 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 29300-127_958d523d-b040-4475-ad89-6278e5cf0f60SPL ID 958d523d-b040-4475-ad89-6278e5cf0f60SPL set ID 4f20df45-3f9c-4a91-b394-e93a08111ec3RxCUI 854901, 854905UNII UR59KN573LUPC 0329300126136, 0329300127133
- 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
N429300012701followed by a unit qualifier and the quantityPackage 29300-0127-01. 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 29300-127
- What is NDC 29300-127?
- 29300-127 is the product NDC for Bisoprolol Fumarate, Bisoprolol fumarate 10 mg/1 tablet, listed with the FDA by Unichem Pharmaceuticals (USA), Inc.. It has 3 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?
- Unichem Pharmaceuticals (USA), Inc., NDC labeler code 29300. 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 10 mg/1 | Tablet, Film coatedOral | Sun Pharmaceutical Industries Limited | 70095-019 | 70095-0019-0170095-0019-02 |
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 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 5 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-8671 |
| Bisoprolol Fumarate | Bisoprolol fumarate 10 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2244 |