DIMETHYL FUMARATE
- Product NDC
- 69238-1626
- 11-digit product format
- 692381626
- Labeler code
- 69238
- Product ID
- 69238-1626_76c5e6b0-c799-45cf-adb6-2d3845639b62
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- DIMETHYL FUMARATE
- Dosage form
- KIT
- Labeler
- Amneal Pharmaceuticals NY LLC
- Application
- ANDA210402
- Marketing category
- ANDA
- Marketing start
- 2020-09-28
- 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
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 |
|---|
| 69238-1626-3 | DIMETHYL FUMARATE | 1 in 1 KIT | KIT | 1 | | 14 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 69238-1626 | DIMETHYL FUMARATE CAPSULE, DELAYED RELEASE DIMETHYL FUMARATE KIT [AMNEAL PHARMACEUTICALS NY LLC] | 13 | Current NDC, Legacy NDC, 1 package rows | 20240629_4c7626c6-2b1b-4865-818c-0c79c18c049d.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 |
|---|
| 69238-1626-3 | 69238162603 | 1 KIT in 1 KIT (69238-1626-3) * 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC * 46 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC | 1 kit | 2020-09-28 | 0000-00-00 | No | No | Current |