DIMETHYL FUMARATE
- Product NDC
- 16729-416
- 11-digit product format
- 167290416
- Labeler code
- 16729
- Product ID
- 16729-416_460073d9-4e0e-e90b-e063-6394a90a4ebc
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Dimethyl fumarate
- Dosage form
- CAPSULE, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Accord Healthcare Inc.
- Application
- ANDA210499
- Marketing category
- ANDA
- Marketing start
- 2021-01-25
- Substance
- DIMETHYL FUMARATE
- Active strength
- 120 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 | 120 mg/1 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 16729-416-04 | DIMETHYL FUMARATE | 14 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 14 | | 8 |
| 16729-416-16 | DIMETHYL FUMARATE | 500 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 500 | | 8 |
| 16729-416-54 | DIMETHYL FUMARATE | 14 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 14 | 120 mg | 8 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 16729-416 | DIMETHYL FUMARATE KIT DIMETHYL FUMARATE CAPSULE, DELAYED RELEASE [ACCORD HEALTHCARE INC.] | 8 | Current NDC, Legacy NDC, 2 package rows | 20230901_c4003a54-f880-4d06-9b5a-f8043791937b.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 16729-416-04 | 16729041604 | 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE (16729-416-04) | 2021-01-25 | 0000-00-00 | No | No | Current |
| 16729-416-16 | 16729041616 | 500 CAPSULE, DELAYED RELEASE in 1 BOTTLE (16729-416-16) | 2022-09-26 | 0000-00-00 | No | No | Current |
| 16729-416-54 | 16729041654 | 14 in 1 BOTTLE | | | | | Historical |