Bisoprolol (bisoprolol fumarate) NDC 71335-1678

NDC codes

FDA NDC Directory

Product NDC (as listed)71335-1678Labeler and product segments. Claims need a package NDC.

Product NDC at billing width71335-1678Add 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
71335-1678-1	71335167801	30 TABLET, FILM COATED in 1 BOTTLE (71335-1678-1)Marketed from Jul 28, 2020
71335-1678-2	71335167802	100 TABLET, FILM COATED in 1 BOTTLE (71335-1678-2)Marketed from Dec 29, 2021
71335-1678-3	71335167803	90 TABLET, FILM COATED in 1 BOTTLE (71335-1678-3)Marketed from Dec 29, 2021
71335-1678-4	71335167804	28 TABLET, FILM COATED in 1 BOTTLE (71335-1678-4)Marketed from Dec 29, 2021
71335-1678-5	71335167805	120 TABLET, FILM COATED in 1 BOTTLE (71335-1678-5)Marketed from Dec 29, 2021

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
Generic name (nonproprietary): bisoprolol fumarate
Active ingredients: Bisoprolol fumarate — 5 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Bryant Ranch Prepack
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 075474
Marketing start: Jun 20, 2019
Listing expires: Dec 31, 2026
Other FDA classes: Adrenergic beta-Antagonists (Mechanism)
Identifiers: Product ID 71335-1678_4bb725ef-4484-4f1a-a2b4-471633683660SPL ID 4bb725ef-4484-4f1a-a2b4-471633683660SPL set ID 91d114ce-5551-455e-82df-d058eb222ac1RxCUI 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

N471335167801 followed by a unit qualifier and the quantity

Package 71335-1678-01. 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 17, 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)

Other NDCs under ANDA 075474

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

FDA NDC Directory listings under ANDA 075474
Product	Strength	Form · route	Labeler	Product NDC
Bisoprololbisoprolol fumarate	Bisoprolol fumarate 5 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	72162-2177
Bisoprololbisoprolol fumarate	Bisoprolol fumarate 5 mg/1	Tablet, Film coatedOral	TruPharma, LLC	52817-270
Bisoprololbisoprolol fumarate	Bisoprolol fumarate 10 mg/1	Tablet, Film coatedOral	TruPharma, LLC	52817-271
Bisoprololbisoprolol fumarate	Bisoprolol fumarate 10 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	63629-6907