DIMETHYL FUMARATE
- Product NDC
- 31722-658
- 11-digit product format
- 317220658
- Labeler code
- 31722
- Product ID
- 31722-658_1814ba82-76cc-c580-e063-6294a90a5e57
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- DIMETHYL FUMARATE
- Dosage form
- CAPSULE, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Camber Pharmaceuticals, Inc.
- Application
- ANDA210500
- Marketing category
- ANDA
- Marketing start
- 2020-09-24
- 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 | 1373483, 1373491, 1373497 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 31722-658-31 | DIMETHYL FUMARATE | 46 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 46 | | 7 |
| 31722-658-31 | DIMETHYL FUMARATE | 1 in 1 CARTON | CAPSULE, DELAYED RELEASE | 1 | | 7 |
| 31722-658-32 | DIMETHYL FUMARATE | 1 in 1 CARTON | CAPSULE, DELAYED RELEASE | 1 | | 7 |
| 31722-658-32 | DIMETHYL FUMARATE | 60 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 60 | | 7 |
| 31722-658-33 | DIMETHYL FUMARATE | 10 in 1 CARTON | CAPSULE, DELAYED RELEASE | 10 | | 7 |
| 31722-658-33 | DIMETHYL FUMARATE | 10 in 1 BLISTER PACK | CAPSULE, DELAYED RELEASE | 10 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 31722-658 | DIMETHYL FUMARATE (DIMETHYL FUMARATE) CAPSULE, DELAYED RELEASE DIMETHYL FUMARATE KIT [CAMBER PHARMACEUTICALS, INC.] | 7 | Current NDC, Legacy NDC, 6 package rows | 20240511_b856ac70-71cd-477b-95b1-0a6132c260e8.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 |
|---|
| 31722-658-31 | 31722065831 | 1 BOTTLE in 1 CARTON (31722-658-31) / 46 CAPSULE, DELAYED RELEASE in 1 BOTTLE | 1 bottle | 2020-09-24 | 0000-00-00 | No | No | Current |
| 31722-658-32 | 31722065832 | 1 BOTTLE in 1 CARTON (31722-658-32) / 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE | 1 bottle | 2020-09-24 | 0000-00-00 | No | No | Current |
| 31722-658-33 | 31722065833 | 10 BLISTER PACK in 1 CARTON (31722-658-33) / 10 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK | 10 blister pack | 2020-09-24 | 0000-00-00 | No | No | Current |