Bisoprolol Fumarate and Hydrochlorothiazide NDC 72578-113

NDC codes

FDA NDC Directory

Product NDC (as listed)72578-113Labeler and product segments. Claims need a package NDC.

Product NDC at billing width72578-0113Add 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
72578-113-01	72578011301	100 TABLET, FILM COATED in 1 BOTTLE (72578-113-01)Marketed from Mar 1, 2023
72578-113-05	72578011305	500 TABLET, FILM COATED in 1 BOTTLE (72578-113-05)Marketed from Mar 1, 2023
72578-113-06	72578011306	30 TABLET, FILM COATED in 1 BOTTLE (72578-113-06)Marketed from Mar 1, 2023

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 and Hydrochlorothiazide
Generic name (nonproprietary): bisoprolol fumarate and hydrochlorothiazide
Active ingredients: Bisoprolol fumarate — 2.5 mg/1Hydrochlorothiazide — 6.25 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Viona Pharmaceuticals Inc
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 215666
Marketing start: Mar 1, 2023
Listing expires: Dec 31, 2027
Other FDA classes: Adrenergic beta-Antagonists (Mechanism)Increased Diuresis (Physiologic effect)Thiazides (Chemical structure)
Identifiers: Product ID 72578-113_3466b097-8648-4110-a130-8754da1f2739SPL ID 3466b097-8648-4110-a130-8754da1f2739SPL set ID 57505d73-f2a8-430b-8703-a0a6bb733c7dRxCUI 854908, 854916, 854919UNII UR59KN573L, 0J48LPH2THUPC 0372578114060, 0372578115067
Pharmacologic class: Thiazide Diuretic; 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

N472578011301 followed by a unit qualifier and the quantity

Package 72578-0113-01. 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 Jul 31, 2026.

Indications (excerpt from the label)

INDICATIONS AND USAGE Bisoprolol fumarate and hydrochlorothiazide tablets are indicated in the management of hypertension.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 215666

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

FDA NDC Directory listings under ANDA 215666
Product	Strength	Form · route	Labeler	Product NDC
Bisoprolol Fumarate and Hydrochlorothiazide	Bisoprolol fumarate 10 mg/1; Hydrochlorothiazide 6.25 mg/1	Tablet, Film coatedOral	Viona Pharmaceuticals Inc	72578-115
Bisoprolol Fumarate and Hydrochlorothiazide	Bisoprolol fumarate 5 mg/1; Hydrochlorothiazide 6.25 mg/1	Tablet, Film coatedOral	Viona Pharmaceuticals Inc	72578-114
Bisoprolol Fumarate and Hydrochlorothiazide	Bisoprolol fumarate 2.5 mg/1; Hydrochlorothiazide 6.25 mg/1	Tablet, Film coatedOral	Zydus Lifesciences Limited	70771-1760
Bisoprolol Fumarate and Hydrochlorothiazide	Bisoprolol fumarate 5 mg/1; Hydrochlorothiazide 6.25 mg/1	Tablet, Film coatedOral	Zydus Lifesciences Limited	70771-1761
Bisoprolol Fumarate and Hydrochlorothiazide	Bisoprolol fumarate 10 mg/1; Hydrochlorothiazide 6.25 mg/1	Tablet, Film coatedOral	Zydus Lifesciences Limited	70771-1762