What is NDC 72578-112?

72578-112 is the product NDC for Bisoprolol Fumarate, Bisoprolol fumarate 10 mg/1 tablet, film coated, listed with the FDA by Viona Pharmaceuticals Inc. It has 2 package NDCs, shown above in 10- and 11-digit form.

Viona Pharmaceuticals Inc, NDC labeler code 72578. 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.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Bisoprolol Fumarate NDC 72578-112 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)72578-112Labeler and product segments. Claims need a package NDC.

Product NDC at billing width72578-0112Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
72578-112-01	7257801120172578011201	100 TABLET, FILM COATED in 1 BOTTLE (72578-112-01)Marketed from Sep 15, 2022
72578-112-06	7257801120672578011206	30 TABLET, FILM COATED in 1 BOTTLE (72578-112-06)Marketed from Sep 15, 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, Film coated
Route: Oral
Labeler: Viona Pharmaceuticals IncNDC labeler code 72578
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 215680
Marketing start: Sep 15, 2022
Listing expires: Dec 31, 2027
Other FDA classes: Adrenergic beta-Antagonists (Mechanism)
Identifiers: Product ID 72578-112_d47ca4c0-7783-43d1-a951-5adca27ea13cSPL ID d47ca4c0-7783-43d1-a951-5adca27ea13cSPL set ID 3c393b41-9423-4ea6-8a79-0cbff0693471RxCUI 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

N472578011201 followed by a unit qualifier and the quantity

Package 72578-0112-01. 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 Nov 10, 2023.

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.

Full label on DailyMed (opens in a new tab)

About NDC 72578-112

What is NDC 72578-112?: 72578-112 is the product NDC for Bisoprolol Fumarate, Bisoprolol fumarate 10 mg/1 tablet, film coated, listed with the FDA by Viona Pharmaceuticals Inc. 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?: Viona Pharmaceuticals Inc, NDC labeler code 72578. 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.

Other finished products listed under the same name: strengths, forms and labelers.

Other Bisoprolol Fumarate NDCs
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

All 41 Bisoprolol Fumarate NDCs

Other NDCs under ANDA 215680

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 215680
Product	Strength	Form · route	Labeler	Product NDC
Bisoprolol Fumarate	Bisoprolol fumarate 5 mg/1	Tablet, Film coatedOral	Zydus Lifesciences Limited	70771-1726
Bisoprolol Fumarate	Bisoprolol fumarate 10 mg/1	Tablet, Film coatedOral	Zydus Lifesciences Limited	70771-1727
Bisoprolol Fumarate	Bisoprolol fumarate 5 mg/1	Tablet, Film coatedOral	Viona Pharmaceuticals Inc	72578-111