Ivabradine NDC 31722-054

NDC codes

FDA NDC Directory

Product NDC (as listed)31722-054Labeler and product segments. Claims need a package NDC.

Product NDC at billing width31722-0054Add 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
31722-054-60	31722005460	60 TABLET, FILM COATED in 1 BOTTLE (31722-054-60)Marketed from Oct 5, 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): Ivabradine
Generic name (nonproprietary): ivabradine
Active ingredients: Ivabradine hydrochloride — 7.5 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Camber Pharmaceuticals, Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 213366
Marketing start: Oct 5, 2022
Listing expires: Dec 31, 2026
Other FDA classes: Hyperpolarization-activated Cyclic Nucleotide-gated Channel Antagonists (Mechanism)
Identifiers: Product ID 31722-054_174dfa8e-391c-3a0d-e063-6294a90af7caSPL ID 174dfa8e-391c-3a0d-e063-6294a90af7caSPL set ID 602d1c55-0e4d-452a-a087-888fdbaa7568RxCUI 1649485, 1649493UNII TP19837BZKUPC 0331722054607, 0331722053600
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

N431722005460 followed by a unit qualifier and the quantity

Package 31722-0054-60. 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 Apr 30, 2024.

Indications (excerpt from the label)

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 contraindication to beta-bl…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 213366

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

FDA NDC Directory listings under ANDA 213366
Product	Strength	Form · route	Labeler	Product NDC
Ivabradine	Ivabradine hydrochloride 5 mg/1	Tablet, Film coatedOral	American Health Packaging	60687-862
Ivabradine	Ivabradine hydrochloride 5 mg/1	Tablet, Film coatedOral	Camber Pharmaceuticals, Inc.	31722-053