Prescription drug · NDA
Corlanor (Ivabradine) NDC 55513-800
Ivabradine hydrochloride 5 mg/1 · Tablet, Film coated · Oral · Amgen Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 55513-800-60 | 5551308006055513080060 | 60 TABLET, FILM COATED in 1 BOTTLE (55513-800-60)Marketed from Apr 20, 2015 | |
| 55513-800-99 | 5551308009955513080099 | 14 TABLET, FILM COATED in 1 BOTTLE (55513-800-99)Marketed from Apr 20, 2015 · Sample package |
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)
- Corlanor
- Generic name (nonproprietary)
- ivabradine
- Active ingredients
- Ivabradine hydrochloride — 5 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Amgen IncNDC labeler code 55513
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 206143
- Marketing start
- Listing expires
- Other FDA classes
- Hyperpolarization-activated Cyclic Nucleotide-gated Channel Antagonists (Mechanism)
- Identifiers
- Product ID 55513-800_8ab000cd-0258-489a-b1bb-4cc1ca359d6cSPL ID 8ab000cd-0258-489a-b1bb-4cc1ca359d6cSPL set ID 92018a65-38f6-45f7-91d4-a34921b81d0dRxCUI 1649485, 1649491, 1649493, 1649495, 2168592, 2168596UNII TP19837BZKUPC 0355513800600, 0355513810609
- 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
N455513080060followed by a unit qualifier and the quantityPackage 55513-0800-60. 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)
1. INDICATIONS AND USAGE Corlanor (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 ) For the treatment of stable symptomatic heart failure due to dilated cardiomyopathy in pediatric patients ages 6 months and older. ( 1.2 ) 1.1 Heart Failure in Adult Patients Corlanor is 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 ar…
Excerpt only. Read the full label for complete information.
About NDC 55513-800
- What is NDC 55513-800?
- 55513-800 is the product NDC for Corlanor (ivabradine), Ivabradine hydrochloride 5 mg/1 tablet, film coated, listed with the FDA by Amgen Inc. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Corlanor (Ivabradine).
- What is the active ingredient?
- Ivabradine hydrochloride.
- Who is the labeler?
- Amgen Inc, NDC labeler code 55513. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Corlanor?
- 2 other product NDCs are listed under this name. See all Corlanor NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Corlanor products
Other finished products listed under the same name: strengths, forms and labelers.
Other NDCs under NDA 206143
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.