dimethyl fumarate
- Product NDC
- 70710-1204
- 11-digit product format
- 707101204
- Labeler code
- 70710
- Product ID
- 70710-1204_548169c7-23fb-46e1-9a8d-556a00ee5cbc
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- dimethyl fumarate
- Dosage form
- CAPSULE, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Zydus Pharmaceuticals USA Inc.
- Application
- ANDA210538
- Marketing category
- ANDA
- Marketing start
- 2020-09-28
- 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 |
|---|
| 70710-1204-7 | 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 |
|---|
| 70710-1204 | DIMETHYL FUMARATE (DIMETHYL FUMARATE) KIT DIMETHYL FUMARATE CAPSULE, DELAYED RELEASE [ZYDUS PHARMACEUTICALS USA INC.] | 5 | Current NDC, Legacy NDC, 1 package rows | 20250403_e7ef9b9e-d97a-4a56-b792-a1a255613156.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 |
|---|
| 70710-1204-7 | 70710120407 | 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE (70710-1204-7) | 2020-09-28 | 0000-00-00 | Yes | No | Current |