Prescription drug · NDA
Multaq (Dronedarone) NDC 55154-8104
Dronedarone 400 mg/1 · Tablet, Film coated · Oral · Cardinal Health 107, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 55154-8104-2 | 55154810402 | 1260 TABLET, FILM COATED in 1 BOTTLE (55154-8104-2)Marketed from Jul 1, 2009 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
- Multaq
- Generic name (nonproprietary)
- dronedarone
- Active ingredients
- Dronedarone — 400 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Cardinal Health 107, LLCNDC labeler code 55154
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 022425
- Marketing start
- Listing expires
- Other FDA classes
- Cytochrome P450 2D6 Inhibitors (Mechanism)Cytochrome P450 3A Inhibitors (Mechanism)P-Glycoprotein Inhibitors (Mechanism)
- Identifiers
- Product ID 55154-8104_913e2175-cc98-4f39-8941-1a46cc80b888SPL ID 913e2175-cc98-4f39-8941-1a46cc80b888SPL set ID 3bd4006a-8bad-4909-ac6d-b6d84390155cRxCUI 854856, 854859UNII JQZ1L091Y2
- Pharmacologic class
- Antiarrhythmic
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
N455154810402followed by a unit qualifier and the quantityPackage 55154-8104-02. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
MULTAQ ® is indicated to reduce the risk of hospitalization for atrial fibrillation in patients in sinus rhythm with a history of paroxysmal or persistent atrial fibrillation (AF) [see Clinical Studies (14) ] . MULTAQ is an antiarrhythmic drug indicated to reduce the risk of hospitalization for atrial fibrillation (AF) in patients in sinus rhythm with a history of paroxysmal or persistent AF ( 1 , 14 ).
Excerpt only. Read the full label for complete information.
About NDC 55154-8104
- What is NDC 55154-8104?
- 55154-8104 is the product NDC for Multaq (dronedarone), Dronedarone 400 mg/1 tablet, film coated, listed with the FDA by Cardinal Health 107, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Multaq (Dronedarone).
- What is the active ingredient?
- Dronedarone.
- Who is the labeler?
- Cardinal Health 107, LLC, NDC labeler code 55154. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Multaq?
- 1 other product NDC are listed under this name. See all Multaq NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Multaq products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Multaqdronedarone | Dronedarone 400 mg/1 | Tablet, Film coatedOral | Sanofi-Aventis U.S. LLC | 0024-4142 | 00024-4142-0000024-4142-0600024-4142-60 |
Other NDCs under NDA 022425
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 |
|---|---|---|---|---|
| Multaqdronedarone | Dronedarone 400 mg/1 | Tablet, Film coatedOral | Sanofi-Aventis U.S. LLC | 0024-4142 |