DIMETHYL FUMARATE
- Product NDC
- 31722-680
- 11-digit product format
- 317220680
- Labeler code
- 31722
- Product ID
- 31722-680_1814ba82-76cc-c580-e063-6294a90a5e57
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- dimethyl fumarate
- Dosage form
- KIT
- Labeler
- Camber Pharmaceuticals, Inc.
- Application
- ANDA210500
- Marketing category
- ANDA
- Marketing start
- 2020-09-24
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 782c9b32-f61c-48d7-9845-328403da8b33 | Product name | 5 | 20250303 |
| fb7ab793-2c12-4079-b100-a64f73bef25a | Product name | 4 | 20240712 |
| b0cbf770-6cc3-4aa4-9158-755110c2b9f7 | Product name | 2 | 20230717 |
| dc7c5daa-021f-40dd-b00d-63982cb2067a | Product name | 1 | 20230426 |
| 08ffbcbf-26df-b99c-1dab-64fc4cfae89f | Product name | 5 | 20200925 |
| 81073386-7d67-4d1d-80dd-72b360506a77 | Product name | 1 | 20200414 |
| 816b97af-edc5-4060-aff1-b814bdbcad50 | Product name | 1 | 20190415 |
| 7cda52fc-125f-421c-8fea-bc1974370c49 | Product name | 2 | 20180703 |
| 419aab54-5d5a-4146-9453-026d4a9991be | Product name | 2 | 20170525 |
| 08ffbcbf-26df-b99c-1dab-64fc4cfae89f | Product name | 2 | 20160823 |
| 89dac932-b90a-4410-9ab1-84c53e57de25 | Product name | 1 | 20150316 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 31722-680-60 | DIMETHYL FUMARATE | 1 in 1 KIT | KIT | 1 | 7 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 31722-680 | DIMETHYL FUMARATE (DIMETHYL FUMARATE) CAPSULE, DELAYED RELEASE DIMETHYL FUMARATE KIT [CAMBER PHARMACEUTICALS, INC.] | 7 | Current NDC, Legacy NDC, 1 package rows | 20240511_b856ac70-71cd-477b-95b1-0a6132c260e8.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1373497 | {14 (dimethyl fumarate 120 MG Delayed Release Oral Capsule) / 46 (dimethyl fumarate 240 MG Delayed Release Oral Capsule) } Pack | GPCK | b856ac70-71cd-477b-95b1-0a6132c260e8 | 7 |
| 1373483 | dimethyl fumarate 120 MG Delayed Release Oral Capsule | PSN | b856ac70-71cd-477b-95b1-0a6132c260e8 | 7 |
| 1373491 | dimethyl fumarate 240 MG Delayed Release Oral Capsule | PSN | b856ac70-71cd-477b-95b1-0a6132c260e8 | 7 |
| 1373497 | dimethyl fumarate starter dose 120 MG (14), 240 MG (46) Delayed Release Oral Capsule 60 Count Pack | PSN | b856ac70-71cd-477b-95b1-0a6132c260e8 | 7 |
| 1373483 | dimethyl fumarate 120 MG Delayed Release Oral Capsule | SCD | b856ac70-71cd-477b-95b1-0a6132c260e8 | 7 |
| 1373491 | dimethyl fumarate 240 MG Delayed Release Oral Capsule | SCD | b856ac70-71cd-477b-95b1-0a6132c260e8 | 7 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 31722-680-60 | 31722068060 | 1 KIT in 1 KIT (31722-680-60) * 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE * 46 CAPSULE, DELAYED RELEASE in 1 BOTTLE | 1 kit | 2020-09-24 | 0000-00-00 | No | No | Current |