Dimethyl Fumarate
- Product NDC
- 67877-557
- 11-digit product format
- 678770557
- Labeler code
- 67877
- Product ID
- 67877-557_75f80267-a5b2-4117-8003-05da3e461217
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Dimethyl Fumarate
- Dosage form
- KIT
- Labeler
- Ascend Laboratories, LLC
- Application
- ANDA210440
- Marketing category
- ANDA
- Marketing start
- 2020-09-26
- 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 |
|---|
| 67877-557-39 | Dimethyl Fumarate | 1 in 1 KIT | KIT | 1 | | 16 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 67877-557 | DIMETHYL FUMARATE CAPSULE, DELAYED RELEASE DIMETHYL FUMARATE KIT [ASCEND LABORATORIES, LLC] | 15 | Current NDC, Legacy NDC, 1 package rows | 20240730_e12d8fee-bd18-4f84-8333-c890f1d132b7.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 67877-557-39 | 67877055739 | 1 KIT in 1 KIT (67877-557-39) * 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC * 46 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC | 1 kit | 2020-09-26 | 0000-00-00 | No | No | Current |