DIMETHYL FUMARATE
- Product NDC
- 82009-138
- 11-digit product format
- 820090138
- Labeler code
- 82009
- Product ID
- 82009-138_425dfa4b-ae5d-578b-e063-6394a90a4d3b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- DIMETHYL FUMARATE
- Dosage form
- CAPSULE, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Quallent Pharmaceuticals Health LLC
- Application
- ANDA210500
- Marketing category
- ANDA
- Marketing start
- 2024-06-15
- 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 | 1373491 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 82009-138-60 | DIMETHYL FUMARATE | 1 in 1 CARTON | CAPSULE, DELAYED RELEASE | 1 | | 2 |
| 82009-138-60 | DIMETHYL FUMARATE | 60 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 60 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 82009-138 | DIMETHYL FUMARATE (DIMETHYL FUMARATE) CAPSULE, DELAYED RELEASE [QUALLENT PHARMACEUTICALS HEALTH LLC] | 1 | Current NDC, 2 package rows | 20240616_39150ef0-ba48-4719-b7fd-9beb4d4ad3ce.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 |
|---|
| 82009-138-60 | 82009013860 | 1 BOTTLE in 1 CARTON (82009-138-60) / 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE | 1 bottle | 2024-06-15 | No | No | Current |