Prescription drug · ANDA
Ivabradine NDC 50742-362
Ivabradine hydrochloride 5 mg/1 · Tablet, Film coated · Oral · Ingenus Pharmaceuticals, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50742-362-60 | 5074203626050742036260 | 60 TABLET, FILM COATED in 1 BOTTLE (50742-362-60)Marketed from Jul 15, 2024 |
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
- Ingenus Pharmaceuticals, LLCNDC labeler code 50742
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 214051
- Marketing start
- Listing expires
- Other FDA classes
- Hyperpolarization-activated Cyclic Nucleotide-gated Channel Antagonists (Mechanism)
- Identifiers
- Product ID 50742-362_6d23c13f-f81d-4bc9-9ded-be94c025e8f7SPL ID 6d23c13f-f81d-4bc9-9ded-be94c025e8f7SPL set ID 2e70f883-8c01-4ac2-815d-4a6d561c711aRxCUI 1649485, 1649493UNII TP19837BZKUPC 0350742363605, 0350742362608
- 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
N450742036260followed by a unit qualifier and the quantityPackage 50742-0362-60. 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 .
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-bloc…
Excerpt only. Read the full label for complete information.
About NDC 50742-362
- What is NDC 50742-362?
- 50742-362 is the product NDC for Ivabradine, Ivabradine hydrochloride 5 mg/1 tablet, film coated, listed with the FDA by Ingenus Pharmaceuticals, 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?
- Ingenus Pharmaceuticals, LLC, NDC labeler code 50742. 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 5 mg/1 | Tablet, Film coatedOral | Northstar Rx LLC | 72603-934 | 72603-0934-01 |
| 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 |
Other NDCs under ANDA 214051
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 7.5 mg/1 | Tablet, Film coatedOral | Ingenus Pharmaceuticals, LLC | 50742-363 |
| Ivabradine | Ivabradine hydrochloride 5 mg/1 | Tablet, Film coatedOral | Golden State Medical Supply, Inc. | 51407-592 |
| Ivabradine | Ivabradine hydrochloride 7.5 mg/1 | Tablet, Film coatedOral | Golden State Medical Supply, Inc. | 51407-593 |