ivabradine NDC 69452-190

NDC codes

FDA NDC Directory

Product NDC (as listed)69452-190Labeler and product segments. Claims need a package NDC.

Product NDC at billing width69452-0190Add 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
69452-190-17	69452019017	60 TABLET, FILM COATED in 1 BOTTLE (69452-190-17)Marketed from Mar 1, 2025
69452-190-30	69452019030	500 TABLET, FILM COATED in 1 BOTTLE (69452-190-30)Marketed from Mar 1, 2025

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): ivabradine
Generic name (nonproprietary): ivabradine
Active ingredients: Ivabradine hydrochloride — 5 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Bionpharma Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 213276
Marketing start: Mar 1, 2025
Listing expires: Dec 31, 2026
Other FDA classes: Hyperpolarization-activated Cyclic Nucleotide-gated Channel Antagonists (Mechanism)
Identifiers: Product ID 69452-190_2eacec81-3528-a573-e063-6394a90a6da4SPL ID 2eacec81-3528-a573-e063-6394a90a6da4SPL set ID 2ead1cf3-e61a-49c4-e063-6294a90a330fRxCUI 1649485, 1649493UNII TP19837BZK
Pharmacologic class: Hyperpolarization-activated Cyclic Nucleotide-gated Channel 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

N469452019017 followed by a unit qualifier and the quantity

Package 69452-0190-17. 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 Feb 24, 2025.

Indications (excerpt from the label)

1. INDICATIONS AND USAGE Ivabradine is a hyperpolarization-activated cyclic nucleotide‑gated channel blocker indicated: To reduce the risk of hospitalization for worsening heart failure in adult patients with stable, symptomatic chronic heart failure with reduced left ventricular ejection fraction. ( 1.1 ) 1.1 Heart Failure in Adult Patients Ivabradine tablets are indicated to reduce the risk of hospitalization for worsening heart failure in adult patients with stable, symptomatic chronic heart failure with left ventricular ejection fraction ≤ 35%, who are in sinus rhythm with resting heart rate ≥ 70 beats per minute and either are on maximally tolerated doses of beta‑blockers or have a cont…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 213276

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

FDA NDC Directory listings under ANDA 213276
Product	Strength	Form · route	Labeler	Product NDC
ivabradine	Ivabradine hydrochloride 7.5 mg/1	Tablet, Film coatedOral	Bionpharma Inc.	69452-191