DIMETHYL FUMARATE
- Product NDC
- 43547-024
- 11-digit product format
- 435470024
- Labeler code
- 43547
- Product ID
- 43547-024_870120b7-7d68-4e5f-98cc-ac646624feb4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- dimethyl fumarate
- Dosage form
- CAPSULE, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Solco Healthcare US, LLC
- Application
- ANDA210414
- Marketing category
- ANDA
- Marketing start
- 2022-10-18
- 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 |
|---|
| 43547-024-14 | DIMETHYL FUMARATE | 14 in 1 BOTTLE, PLASTIC | CAPSULE, DELAYED RELEASE | 14 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43547-024 | DIMETHYL FUMARATE CAPSULE, DELAYED RELEASE [SOLCO HEALTHCARE US, LLC] | 5 | Current NDC, Legacy NDC, 1 package rows | 20240927_a3677dce-a44b-481f-8a76-9ff3a4d42105.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 |
|---|
| 43547-024-14 | 43547002414 | 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (43547-024-14) | 2022-10-18 | 0000-00-00 | No | No | Current |