Dimethyl Fumarate
- Product NDC
- 59651-083
- 11-digit product format
- 596510083
- Labeler code
- 59651
- Product ID
- 59651-083_4d4ea332-4695-4c8c-ba54-c6e24fdee31c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Dimethyl Fumarate
- Dosage form
- CAPSULE, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Aurobindo Pharma Limited
- Application
- ANDA210385
- Marketing category
- ANDA
- Marketing start
- 2022-12-22
- 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 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 59651-083-14 | Dimethyl Fumarate | 14 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 14 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 59651-083 | DIMETHYL FUMARATE CAPSULE, DELAYED RELEASE [AUROBINDO PHARMA LIMITED] | 5 | Current NDC, Legacy NDC, 1 package rows | 20240430_08f3a987-6571-42b3-854b-186d782b4494.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 |
|---|
| 59651-083-14 | 59651008314 | 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE (59651-083-14) | 2022-12-22 | 0000-00-00 | No | No | Current |