DIMETHYL FUMARATE
- Product NDC
- 16729-418
- 11-digit product format
- 167290418
- Labeler code
- 16729
- Product ID
- 16729-418_be61928a-eb94-3a3f-e053-2a95a90a1397
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- DIMETHYL FUMARATE
- Dosage form
- KIT
- Labeler
- Accord Healthcare Inc.
- Application
- ANDA210499
- Marketing category
- ANDA
- Marketing start
- 2022-09-26
- Marketing end
- 0000-00-00
- Active strength
- 0
- NDC exclude flag
- No
- Listing certified through
- 2022-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 16729-416-54 | DIMETHYL FUMARATE | 14 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 14 | 120 mg | 8 |
| 16729-417-46 | DIMETHYL FUMARATE | 46 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 46 | 240 mg | 8 |
| 16729-418-12 | DIMETHYL FUMARATE | 1 in 1 KIT | KIT | 1 | | 8 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 16729-418 | DIMETHYL FUMARATE KIT DIMETHYL FUMARATE CAPSULE, DELAYED RELEASE [ACCORD HEALTHCARE INC.] | 8 | Legacy NDC, 3 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 | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 16729-416-54 | 16729041654 | 14 in 1 BOTTLE | | | | | | Historical |
| 16729-417-46 | 16729041746 | 46 in 1 BOTTLE | | | | | | Historical |
| 16729-418-12 | 16729041812 | 1 KIT in 1 KIT (16729-418-12) * 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE (16729-416-54) * 46 CAPSULE, DELAYED RELEASE in 1 BOTTLE (16729-417-46) | 1 kit | 2022-09-26 | 0000-00-00 | No | No | Current |