Multaq
- Product NDC
- 53360-4142
- 11-digit product format
- 533604142
- Labeler code
- 53360
- Product ID
- 53360-4142_fecbdf4d-7761-4945-a23c-5edcc2ed0e4d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- dronedarone
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Sanofi Winthrop Industries
- Application
- NDA022425
- Marketing category
- NDA
- Marketing start
- 2009-07-01
- Marketing end
- 0000-00-00
- Substance
- DRONEDARONE
- Active strength
- 400 mg/1
- Pharmacologic classes
- Antiarrhythmic [EPC],Cytochrome P450 3A Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA]
- NDC exclude flag
- E
- Listing certified through
- 2018-12-31
- Current FDA listing
- Historical FDA.report record
Additional Listing Data#
- Finished product
- No
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DRONEDARONE | 400 mg/1 |
FDA-Initiated Inactive NDC Indexing#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Status |
|---|
| 53360-4142-1 | 53360414201 | 50 BLISTER PACK in 1 BOX (53360-4142-1) / 6 TABLET, FILM COATED in 1 BLISTER PACK | 50 blister pack | 01-JUL-09 | Current |
| 53360-4142-6 | 53360414206 | 50 BLISTER PACK in 1 BOX (53360-4142-6) / 6 TABLET, FILM COATED in 1 BLISTER PACK | 50 blister pack | 01-JUL-09 | Current |