Bisoprolol Fumarate and Hydrochlorothiazide NDC 59651-678

NDC codes

FDA NDC Directory

Product NDC (as listed)59651-678Labeler and product segments. Claims need a package NDC.

Product NDC at billing width59651-0678Add 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
59651-678-01	59651067801	100 TABLET, FILM COATED in 1 BOTTLE (59651-678-01)Marketed from Jan 21, 2026
59651-678-05	59651067805	500 TABLET, FILM COATED in 1 BOTTLE (59651-678-05)Marketed from Jan 21, 2026
59651-678-30	59651067830	30 TABLET, FILM COATED in 1 BOTTLE (59651-678-30)Marketed from Jan 21, 2026

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: Aurobindo Pharma Limited
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 217922
Marketing start: Jan 21, 2026
Listing expires: Dec 31, 2027
Other FDA classes: Adrenergic beta-Antagonists (Mechanism)Increased Diuresis (Physiologic effect)Thiazides (Chemical structure)
Identifiers: Product ID 59651-678_2db1a899-f115-4da5-89fe-6e5b41086f6cSPL ID 2db1a899-f115-4da5-89fe-6e5b41086f6cSPL set ID 2db1a899-f115-4da5-89fe-6e5b41086f6cRxCUI 854908, 854916, 854919UNII UR59KN573L, 0J48LPH2TH
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

N459651067801 followed by a unit qualifier and the quantity

Package 59651-0678-01. 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 Jan 30, 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 217922

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

FDA NDC Directory listings under ANDA 217922
Product	Strength	Form · route	Labeler	Product NDC
Bisoprolol Fumarate and Hydrochlorothiazide	Bisoprolol fumarate 10 mg/1; Hydrochlorothiazide 6.25 mg/1	Tablet, Film coatedOral	Aurobindo Pharma Limited	59651-680
Bisoprolol Fumarate and Hydrochlorothiazide	Bisoprolol fumarate 5 mg/1; Hydrochlorothiazide 6.25 mg/1	Tablet, Film coatedOral	Aurobindo Pharma Limited	59651-679