Dimethyl Fumarate
- Product NDC
- 33342-579
- 11-digit product format
- 333420579
- Labeler code
- 33342
- Product ID
- 33342-579_ef3e9cf5-b172-4e67-b621-dc94e9e9d93f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Dimethyl Fumarate
- Dosage form
- KIT
- Labeler
- Macleods Pharmaceuticals Limited
- Application
- ANDA210377
- Marketing category
- ANDA
- Marketing start
- 2025-06-27
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| FO2303MNI2 | DIMETHYL FUMARATE | 624-49-7 | Dimethyl Fumarate |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 33342-579-96 | 33342057996 | 1 KIT in 1 KIT (33342-579-96) * 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE (33342-349-94) * 46 CAPSULE, DELAYED RELEASE in 1 BOTTLE (33342-350-95) | 1 kit | 2025-06-27 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Dimethyl Fumarate | Macleods Pharmaceuticals Limited | 2025-07-29 | Human Prescription Drug Label | 2 |