DIMETHYL FUMARATE
- Product NDC
- 50090-5288
- 11-digit product format
- 500905288
- Labeler code
- 50090
- Product ID
- 50090-5288_43b9bf3a-1ec7-4ca5-9931-61528baadc39
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- DIMETHYL FUMARATE
- Dosage form
- CAPSULE, DELAYED RELEASE
- Route
- ORAL
- Labeler
- A-S Medication Solutions
- Application
- ANDA210500
- Marketing category
- ANDA
- Marketing start
- 2020-09-24
- Substance
- DIMETHYL FUMARATE
- Active strength
- 240 mg/1
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- DIMETHYL FUMARATE
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DIMETHYL FUMARATE | 240 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | FO2303MNI2 |
| Rxcui | 1373491 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 50090-5288-0 | DIMETHYL FUMARATE | 1 in 1 KIT | CAPSULE, DELAYED RELEASE | 1 | | 12 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50090-5288 | DIMETHYL FUMARATE CAPSULE, DELAYED RELEASE [A-S MEDICATION SOLUTIONS] | 9 | Current NDC, Legacy NDC, 1 package rows | 20231217_c2b19329-5c1d-4879-85a9-36ffec3ff5cb.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 |
|---|
| 50090-5288-0 | 50090528800 | 1 CAPSULE, DELAYED RELEASE in 1 KIT (50090-5288-0) | 2020-10-23 | 0000-00-00 | No | No | Current |