Prescription drug · ANDA
Ivabradine NDC 72603-934
Ivabradine hydrochloride 5 mg/1 · Tablet, Film coated · Oral · Northstar Rx LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72603-934-01 | 7260309340172603093401 | 60 TABLET, FILM COATED in 1 BOTTLE (72603-934-01)Marketed from Jul 1, 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)
- Ivabradine
- Generic name (nonproprietary)
- ivabradine
- Active ingredients
- Ivabradine hydrochloride — 5 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Northstar Rx LLCNDC labeler code 72603
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 213483
- Marketing start
- Listing expires
- Other FDA classes
- Hyperpolarization-activated Cyclic Nucleotide-gated Channel Antagonists (Mechanism)
- Identifiers
- Product ID 72603-934_a7fb4728-1c41-4c01-8adb-a22dca0b1b1bSPL ID a7fb4728-1c41-4c01-8adb-a22dca0b1b1bSPL set ID 5157767b-16d5-4a69-b6bd-95d360d19fdaRxCUI 1649485, 1649493UNII TP19837BZKUPC 0372603935011, 0372603934014
- 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
N472603093401followed by a unit qualifier and the quantityPackage 72603-0934-01. 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 .
Indications (excerpt from the label)
Ivabradine tablets are 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 …
Excerpt only. Read the full label for complete information.
About NDC 72603-934
- What is NDC 72603-934?
- 72603-934 is the product NDC for Ivabradine, Ivabradine hydrochloride 5 mg/1 tablet, film coated, listed with the FDA by Northstar Rx LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Ivabradine.
- What is the active ingredient?
- Ivabradine hydrochloride.
- Who is the labeler?
- Northstar Rx LLC, NDC labeler code 72603. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Ivabradine?
- 20 other product NDCs are listed under this name. See all Ivabradine NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Ivabradine products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Ivabradine | Ivabradine hydrochloride 5 mg/1 | Tablet, Film coatedOral | American Health Packaging | 60687-862 | 60687-0862-21 |
| Ivabradine | Ivabradine hydrochloride 5 mg/1 | Tablet, Film coatedOral | Novadoz Pharmaceuticals LLC | 72205-336 | 72205-0336-1872205-0336-60 |
| Ivabradine | Ivabradine hydrochloride 7.5 mg/1 | Tablet, Film coatedOral | Novadoz Pharmaceuticals LLC | 72205-337 | 72205-0337-1872205-0337-60 |
| Ivabradine | Ivabradine hydrochloride 7.5 mg/1 | Tablet, Film coatedOral | Northstar Rx LLC | 72603-935 | 72603-0935-01 |
| ivabradine | Ivabradine hydrochloride 5 mg/1 | Tablet, Film coatedOral | Bionpharma Inc. | 69452-190 | 69452-0190-1769452-0190-30 |
| ivabradine | Ivabradine hydrochloride 7.5 mg/1 | Tablet, Film coatedOral | Bionpharma Inc. | 69452-191 | 69452-0191-1769452-0191-30 |
| Ivabradine | Ivabradine hydrochloride 5 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Limited | 46708-679 | 46708-0679-4546708-0679-60 |
| Ivabradine | Ivabradine hydrochloride 7.5 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Limited | 46708-680 | 46708-0680-4546708-0680-60 |
| Ivabradine | Ivabradine hydrochloride 5 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Inc. | 62332-679 | 62332-0679-4562332-0679-60 |
| Ivabradine | Ivabradine hydrochloride 7.5 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Inc. | 62332-680 | 62332-0680-4562332-0680-60 |
Other NDCs under ANDA 213483
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Ivabradine | Ivabradine hydrochloride 5 mg/1 | Tablet, Film coatedOral | Novadoz Pharmaceuticals LLC | 72205-336 |
| Ivabradine | Ivabradine hydrochloride 7.5 mg/1 | Tablet, Film coatedOral | Novadoz Pharmaceuticals LLC | 72205-337 |
| Ivabradine | Ivabradine hydrochloride 7.5 mg/1 | Tablet, Film coatedOral | Northstar Rx LLC | 72603-935 |