MAYZENT
- Product NDC
- 0078-0986
- 11-digit product format
- 000780986
- Labeler code
- 0078
- Product ID
- 0078-0986_905dd6df-a774-4f5c-aa7a-f21c79944ed6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- siponimod
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Novartis Pharmaceuticals Corporation
- Application
- NDA209884
- Marketing category
- NDA
- Marketing start
- 2019-03-26
- Substance
- SIPONIMOD
- Active strength
- 2 mg/1
- Pharmacologic classes
- Sphingosine 1-Phosphate Receptor Modulators [MoA], Sphingosine 1-phosphate Receptor Modulator [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- MAYZENT
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| SIPONIMOD | 2 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | RR6P8L282I |
| Rxcui | 2121090, 2121096, 2121098, 2121100, 2123313, 2123314, 2594606, 2594608, 2594796, 2594797 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 0078-0986-15 | 2023-08-01 | C162847 | 48780-1 | 0191ceaa-6643-198a-e063-dbdaa90aec3e | These highlights do not include all the information needed to use MAYZENT safely and effectively. See full prescribing information for MAYZENT. MAYZENT ® (siponimod) tablets, for oral use Initial U.S. Approval: 2019 |
| 0078-0986-45 | 2023-08-01 | C162847 | 48780-1 | 0191ceaa-6643-198a-e063-dbdaa90aec3e | These highlights do not include all the information needed to use MAYZENT safely and effectively. See full prescribing information for MAYZENT. MAYZENT ® (siponimod) tablets, for oral use Initial U.S. Approval: 2019 |
| 0078-0986-93 | 2023-08-01 | C162847 | 48780-1 | 0191ceaa-6643-198a-e063-dbdaa90aec3e | These highlights do not include all the information needed to use MAYZENT safely and effectively. See full prescribing information for MAYZENT. MAYZENT ® (siponimod) tablets, for oral use Initial U.S. Approval: 2019 |
| 0078-0986-94 | 2023-08-01 | C162847 | 48780-1 | 0191ceaa-6643-198a-e063-dbdaa90aec3e | These highlights do not include all the information needed to use MAYZENT safely and effectively. See full prescribing information for MAYZENT. MAYZENT ® (siponimod) tablets, for oral use Initial U.S. Approval: 2019 |
| 0078-0986-15 | 2023-07-28 | C162847 | 48780-1 | 0191ceaa-6643-198a-e063-dbdaa90aec3e | These highlights do not include all the information needed to use MAYZENT safely and effectively. See full prescribing information for MAYZENT. MAYZENT ® (siponimod) tablets, for oral use Initial U.S. Approval: 2019 |
| 0078-0986-45 | 2023-07-28 | C162847 | 48780-1 | 0191ceaa-6643-198a-e063-dbdaa90aec3e | These highlights do not include all the information needed to use MAYZENT safely and effectively. See full prescribing information for MAYZENT. MAYZENT ® (siponimod) tablets, for oral use Initial U.S. Approval: 2019 |
| 0078-0986-93 | 2023-07-28 | C162847 | 48780-1 | 0191ceaa-6643-198a-e063-dbdaa90aec3e | These highlights do not include all the information needed to use MAYZENT safely and effectively. See full prescribing information for MAYZENT. MAYZENT ® (siponimod) tablets, for oral use Initial U.S. Approval: 2019 |
| 0078-0986-94 | 2023-07-28 | C162847 | 48780-1 | 0191ceaa-6643-198a-e063-dbdaa90aec3e | These highlights do not include all the information needed to use MAYZENT safely and effectively. See full prescribing information for MAYZENT. MAYZENT ® (siponimod) tablets, for oral use Initial U.S. Approval: 2019 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0078-0986-15 | MAYZENT | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 16 |
| 0078-0986-45 | MAYZENT | 15 in 1 BOTTLE | TABLET, FILM COATED | 15 | | 16 |
| 0078-0986-93 | MAYZENT | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 16 |
| 0078-0986-94 | MAYZENT | 15 in 1 BOTTLE | TABLET, FILM COATED | 15 | | 16 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0078-0986 | MAYZENT (SIPONIMOD) TABLET, FILM COATED [NOVARTIS PHARMACEUTICALS CORPORATION] | 14 | Current NDC, Legacy NDC, 4 package rows | 20240724_44492772-5aed-4627-bd85-e8e89f308bb3.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 |
|---|
| 0078-0986-15 | 00078098615 | 30 TABLET, FILM COATED in 1 BOTTLE (0078-0986-15) | 2019-03-26 | 0000-00-00 | No | No | Current |
| 0078-0986-45 | 00078098645 | 15 TABLET, FILM COATED in 1 BOTTLE (0078-0986-45) | 2022-03-01 | 0000-00-00 | No | No | Current |
| 0078-0986-93 | 00078098693 | 30 TABLET, FILM COATED in 1 BOTTLE (0078-0986-93) | 2019-03-26 | 0000-00-00 | Yes | No | Current |
| 0078-0986-94 | 00078098694 | 15 TABLET, FILM COATED in 1 BOTTLE (0078-0986-94) | 2022-03-01 | 0000-00-00 | Yes | No | Current |