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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Dimethyl Fumarate
- Listing expiration
- 2026-12-31
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | FO2303MNI2 |
| Rxcui | 1373483, 1373491, 1373497 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 33342-349-94 | Dimethyl Fumarate | 14 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 14 | 120 mg | 2 |
| 33342-350-95 | Dimethyl Fumarate | 46 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 46 | 240 mg | 2 |
| 33342-579-96 | Dimethyl Fumarate | 1 in 1 KIT | KIT | 1 | | 2 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 33342-349-94 | 33342034994 | 14 in 1 BOTTLE | | | | | Historical |
| 33342-350-95 | 33342035095 | 46 in 1 BOTTLE | | | | | Historical |
| 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 | Current |