Dimethyl fumarate
- Product NDC
- 0378-0399
- 11-digit product format
- 003780399
- Labeler code
- 0378
- Product ID
- 0378-0399_2c91a409-14e1-40cc-97b1-4df7efa2ae98
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Dimethyl fumarate
- Dosage form
- CAPSULE, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Mylan Pharmaceuticals Inc.
- Application
- ANDA210531
- Marketing category
- ANDA
- Marketing start
- 2020-08-18
- Marketing end
- 0000-00-00
- Substance
- DIMETHYL FUMARATE
- Active strength
- 240 mg/1
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0378-0399 | DIMETHYL FUMARATE CAPSULE, DELAYED RELEASE [MYLAN PHARMACEUTICALS INC.] | 12 | Legacy NDC | 20240719_6745e790-b4e7-47bd-b636-87bc977ccff3.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0378-0399-18 | 00378039918 | 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (0378-0399-18) | 2021-07-16 | 2022-10-31 | No | No | Current |
| 0378-0399-91 | 00378039991 | 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (0378-0399-91) | 2020-08-18 | 0000-00-00 | No | No | Current |