DIMETHYL FUMARATE
- Product NDC
- 68462-570
- 11-digit product format
- 684620570
- Labeler code
- 68462
- Product ID
- 68462-570_74611591-657b-40e8-8ae1-1e5533a05d97
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- dimethyl fumarate kit
- Dosage form
- KIT
- Labeler
- Glenmark Pharmaceuticals Inc., USA
- Application
- ANDA210309
- Marketing category
- ANDA
- Marketing start
- 2020-10-06
- 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 |
|---|
| 68462-570-78 | DIMETHYL FUMARATE | 1 in 1 KIT | KIT | 1 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68462-570 | DIMETHYL FUMARATE (DIMETHYL FUMARATE KIT) KIT DIMETHYL FUMARATE (DIMETHYL-FUMARATE) CAPSULE [GLENMARK PHARMACEUTICALS INC., USA] | 7 | Current NDC, Legacy NDC, 1 package rows | 20240427_c3f65da9-f5f4-4161-aded-c23b16fd49ed.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 |
|---|
| 68462-570-78 | 68462057078 | 1 KIT in 1 KIT (68462-570-78) * 14 CAPSULE in 1 BOTTLE * 46 CAPSULE in 1 BOTTLE | 1 kit | 2020-10-06 | 0000-00-00 | No | No | Current |