Dimethyl fumarate
- Product NDC
- 67877-555
- 11-digit product format
- 678770555
- Labeler code
- 67877
- Product ID
- 67877-555_75f80267-a5b2-4117-8003-05da3e461217
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Dimethyl fumarate
- Dosage form
- CAPSULE, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Ascend Laboratories, LLC
- Application
- ANDA210440
- Marketing category
- ANDA
- Marketing start
- 2020-09-26
- Substance
- DIMETHYL FUMARATE
- Active strength
- 120 mg/1
- 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
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DIMETHYL FUMARATE | 120 mg/1 |
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 |
|---|
| 67877-555-10 | Dimethyl fumarate | 1000 in 1 BOTTLE, PLASTIC | CAPSULE, DELAYED RELEASE | 1000 | | 16 |
| 67877-555-14 | Dimethyl fumarate | 14 in 1 BOTTLE, PLASTIC | CAPSULE, DELAYED RELEASE | 14 | | 16 |
| 67877-555-33 | Dimethyl fumarate | 10 in 1 BLISTER PACK | CAPSULE, DELAYED RELEASE | 10 | | 16 |
| 67877-555-90 | Dimethyl fumarate | 90 in 1 BOTTLE, PLASTIC | CAPSULE, DELAYED RELEASE | 90 | | 16 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 67877-555 | DIMETHYL FUMARATE CAPSULE, DELAYED RELEASE DIMETHYL FUMARATE KIT [ASCEND LABORATORIES, LLC] | 15 | Current NDC, Legacy NDC, 4 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 | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 67877-555-10 | 67877055510 | 1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (67877-555-10) | 2020-09-26 | 0000-00-00 | No | No | Current |
| 67877-555-14 | 67877055514 | 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (67877-555-14) | 2020-09-26 | 0000-00-00 | No | No | Current |
| 67877-555-33 | 67877055533 | 10 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (67877-555-33) | 2020-09-26 | 0000-00-00 | No | No | Current |
| 67877-555-90 | 67877055590 | 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (67877-555-90) | 2020-09-26 | 0000-00-00 | No | No | Current |