Dimethyl Fumarate
- Product NDC
- 43598-429
- 11-digit product format
- 435980429
- Labeler code
- 43598
- Product ID
- 43598-429_fcfea8cf-7720-664c-345c-b8baeff438ee
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Dimethyl fumarate
- Dosage form
- CAPSULE, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Dr. Reddy's Laboratories Inc.
- Application
- ANDA210460
- Marketing category
- ANDA
- Marketing start
- 2020-09-25
- 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 |
|---|
| 43598-429-52 | Dimethyl Fumarate | 1 in 1 CARTON | CAPSULE, DELAYED RELEASE | 1 | | 6 |
| 43598-429-52 | Dimethyl Fumarate | 14 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 14 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43598-429 | DIMETHYL FUMARATE CAPSULE, DELAYED RELEASE [DR. REDDY'S LABORATORIES INC.] | 5 | Current NDC, Legacy NDC, 2 package rows | 20240831_b00dcf89-59d3-9ab2-fd9b-16b9ec2d677b.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 |
|---|
| 43598-429-52 | 43598042952 | 1 BOTTLE in 1 CARTON (43598-429-52) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE | 1 bottle | 2020-09-25 | 0000-00-00 | No | No | Current |