Vumerity
- Product NDC
- 64406-020
- 11-digit product format
- 644060020
- Labeler code
- 64406
- Product ID
- 64406-020_25e0bcfe-8df7-4a62-9db1-ba39a266e8bd
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- diroximel fumarate
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Biogen Inc.
- Application
- NDA211855
- Marketing category
- NDA
- Marketing start
- 2019-10-29
- Substance
- DIROXIMEL FUMARATE
- Active strength
- 231 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
- Vumerity
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DIROXIMEL FUMARATE | 231 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | K0N0Z40J3W |
| Rxcui | 2261788, 2261794 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 64406-020-01 | 2024-08-07 | C162847 | 48780-1 | 1e7a6dab-175b-a2ce-e063-dadaa90aadf7 | These highlights do not include all the information needed to use VUMERITY ® safely and effectively. See full prescribing information for VUMERITY. VUMERITY ® (diroximel fumarate) delayed-release capsules, for oral use Initial U.S. Approval: 2013 |
| 64406-020-03 | 2024-08-07 | C162847 | 48780-1 | 1e7a6dab-175b-a2ce-e063-dadaa90aadf7 | These highlights do not include all the information needed to use VUMERITY ® safely and effectively. See full prescribing information for VUMERITY. VUMERITY ® (diroximel fumarate) delayed-release capsules, for oral use Initial U.S. Approval: 2013 |
| 64406-020-05 | 2024-08-07 | C162847 | 48780-1 | 1e7a6dab-175b-a2ce-e063-dadaa90aadf7 | These highlights do not include all the information needed to use VUMERITY ® safely and effectively. See full prescribing information for VUMERITY. VUMERITY ® (diroximel fumarate) delayed-release capsules, for oral use Initial U.S. Approval: 2013 |
| 64406-020-07 | 2024-08-07 | C162847 | 48780-1 | 1e7a6dab-175b-a2ce-e063-dadaa90aadf7 | These highlights do not include all the information needed to use VUMERITY ® safely and effectively. See full prescribing information for VUMERITY. VUMERITY ® (diroximel fumarate) delayed-release capsules, for oral use Initial U.S. Approval: 2013 |
| 64406-020-01 | 2024-07-30 | C162847 | 48780-1 | 1e7a6dab-175b-a2ce-e063-dadaa90aadf7 | These highlights do not include all the information needed to use VUMERITY ® safely and effectively. See full prescribing information for VUMERITY. VUMERITY ® (diroximel fumarate) delayed-release capsules, for oral use Initial U.S. Approval: 2013 |
| 64406-020-03 | 2024-07-30 | C162847 | 48780-1 | 1e7a6dab-175b-a2ce-e063-dadaa90aadf7 | These highlights do not include all the information needed to use VUMERITY ® safely and effectively. See full prescribing information for VUMERITY. VUMERITY ® (diroximel fumarate) delayed-release capsules, for oral use Initial U.S. Approval: 2013 |
| 64406-020-05 | 2024-07-30 | C162847 | 48780-1 | 1e7a6dab-175b-a2ce-e063-dadaa90aadf7 | These highlights do not include all the information needed to use VUMERITY ® safely and effectively. See full prescribing information for VUMERITY. VUMERITY ® (diroximel fumarate) delayed-release capsules, for oral use Initial U.S. Approval: 2013 |
| 64406-020-07 | 2024-07-30 | C162847 | 48780-1 | 1e7a6dab-175b-a2ce-e063-dadaa90aadf7 | These highlights do not include all the information needed to use VUMERITY ® safely and effectively. See full prescribing information for VUMERITY. VUMERITY ® (diroximel fumarate) delayed-release capsules, for oral use Initial U.S. Approval: 2013 |
DailyMed Package Descriptions#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 64406-020 | VUMERITY (DIROXIMEL FUMARATE) CAPSULE [BIOGEN INC.] | 15 | Current NDC, Legacy NDC, 8 package rows | 20241109_2d74414f-6b83-4ea2-9a95-3cecabbce774.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 |
|---|
| 64406-020-01 | 64406002001 | 1 BOTTLE, PLASTIC in 1 CARTON (64406-020-01) > 106 CAPSULE in 1 BOTTLE, PLASTIC | 2019-10-29 | 0000-00-00 | No | No | Current |
| 64406-020-03 | 64406002003 | 1 BOTTLE, PLASTIC in 1 CARTON (64406-020-03) / 120 CAPSULE in 1 BOTTLE, PLASTIC | 2019-10-29 | 0000-00-00 | No | No | Current |
| 64406-020-05 | 64406002005 | 1 BOTTLE, PLASTIC in 1 CARTON (64406-020-05) > 106 CAPSULE in 1 BOTTLE, PLASTIC | 2019-10-29 | 0000-00-00 | Yes | No | Current |
| 64406-020-07 | 64406002007 | 1 BOTTLE, PLASTIC in 1 CARTON (64406-020-07) / 14 CAPSULE in 1 BOTTLE, PLASTIC | 2022-09-01 | 0000-00-00 | Yes | No | Current |