Dimethyl Fumarate
- Product NDC
- 70512-853
- 11-digit product format
- 705120853
- Labeler code
- 70512
- Product ID
- 70512-853_457243f3-2d22-3222-e063-6394a90ae21e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Dimethyl Fumarate
- Dosage form
- CAPSULE, DELAYED RELEASE
- Route
- ORAL
- Labeler
- SOLA Pharmaceuticals, LLC
- Application
- ANDA210436
- Marketing category
- ANDA
- Marketing start
- 2023-01-31
- Substance
- DIMETHYL FUMARATE
- Active strength
- 240 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 | 240 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 |
|---|
| 70512-853-60 | Dimethyl Fumarate | 60 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 60 | | 8 |
| 70512-853-60 | Dimethyl Fumarate | 1 in 1 CARTON | CAPSULE, DELAYED RELEASE | 1 | | 8 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70512-853 | DIMETHYL FUMARATE CAPSULE, DELAYED RELEASE [SOLA PHARMACEUTICALS, LLC] | 7 | Current NDC, 2 package rows | 20240522_b4a200c1-f25a-4aa8-8770-06182fdeda9d.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 70512-853-60 | 70512085360 | 1 BOTTLE in 1 CARTON (70512-853-60) / 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE | 1 bottle | 2023-03-12 | No | No | Historical |