MAYZENT

Product NDC
0078-0979
11-digit product format
000780979
Labeler code
0078
Product ID
0078-0979_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
.25 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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N209884-001MAYZENTSIPONIMODEQ 0.25MG BASETABLET / ORALRLD2019-03-26
N209884-002MAYZENTSIPONIMODEQ 2MG BASETABLET / ORALRLD, RS2019-03-26
N209884-003MAYZENTSIPONIMODEQ 1MG BASETABLET / ORALRLD2021-08-24

Orange Book patents#

Current patent rows page 1 of 1 · 15 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N209884-00179395192028-08-27Drug substance, Drug product2019-04-19
N209884-00184924412030-11-30U-25112019-04-19
N209884-001120714022032-01-05Drug product2024-09-26
N209884-001119446022036-04-23U-38892024-04-30
N209884-001125333402036-04-23U-44072026-02-13
N209884-00279395192028-08-27Drug substance, Drug product2019-04-19
N209884-00284924412030-11-30U-25112019-04-19
N209884-002120714022032-01-05Drug product2024-09-26
N209884-002119446022036-04-23U-38892024-04-30
N209884-002125333402036-04-23U-44072026-02-13
N209884-00379395192028-08-27Drug substance, Drug product2021-09-22
N209884-00384924412030-11-30U-25112021-09-22
N209884-003120714022032-01-05Drug product2024-09-26
N209884-003119446022036-04-23U-38892024-04-30
N209884-003125333402036-04-23U-44072026-02-13

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 3 · 115 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N209884-001MAYZENTEQ 0.25MG BASETABLET / ORALRLD2019-03-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209884-002MAYZENTEQ 2MG BASETABLET / ORALRLD, RS2019-03-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209884-003MAYZENTEQ 1MG BASETABLET / ORALRLD2021-08-24011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N209884-001MAYZENTEQ 0.25MG BASETABLET / ORALRLD2019-03-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N209884-002MAYZENTEQ 2MG BASETABLET / ORALRLD, RS2019-03-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N209884-003MAYZENTEQ 1MG BASETABLET / ORALRLD2021-08-2431067a03dcf5…
2025-08-23 18:47 UTC2025-08N209884-001MAYZENTEQ 0.25MG BASETABLET / ORALRLD2019-03-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08N209884-002MAYZENTEQ 2MG BASETABLET / ORALRLD, RS2019-03-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08N209884-003MAYZENTEQ 1MG BASETABLET / ORALRLD2021-08-246a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N209884-001MAYZENTEQ 0.25MG BASETABLET / ORALRLD2019-03-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N209884-002MAYZENTEQ 2MG BASETABLET / ORALRLD, RS2019-03-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N209884-003MAYZENTEQ 1MG BASETABLET / ORALRLD2021-08-24fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N209884-001MAYZENTEQ 0.25MG BASETABLET / ORALRLD2019-03-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N209884-002MAYZENTEQ 2MG BASETABLET / ORALRLD, RS2019-03-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N209884-003MAYZENTEQ 1MG BASETABLET / ORALRLD2021-08-24b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N209884-001MAYZENTEQ 0.25MG BASETABLET / ORALRLD2019-03-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N209884-002MAYZENTEQ 2MG BASETABLET / ORALRLD, RS2019-03-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N209884-003MAYZENTEQ 1MG BASETABLET / ORALRLD2021-08-2403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N209884-001MAYZENTEQ 0.25MG BASETABLET / ORALRLD2019-03-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N209884-002MAYZENTEQ 2MG BASETABLET / ORALRLD, RS2019-03-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N209884-003MAYZENTEQ 1MG BASETABLET / ORALRLD2021-08-242680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N209884-001MAYZENTEQ 0.25MG BASETABLET / ORALRLD2019-03-265bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N209884-002MAYZENTEQ 2MG BASETABLET / ORALRLD, RS2019-03-265bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N209884-003MAYZENTEQ 1MG BASETABLET / ORALRLD2021-08-245bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N209884-001MAYZENTEQ 0.25MG BASETABLET / ORALRLD2019-03-26d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N209884-002MAYZENTEQ 2MG BASETABLET / ORALRLD, RS2019-03-26d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N209884-003MAYZENTEQ 1MG BASETABLET / ORALRLD2021-08-24d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N209884-001MAYZENTEQ 0.25MG BASETABLET / ORALRLD2019-03-26d06236e962d9…
2024-10-29 15:01 UTC2024-10N209884-002MAYZENTEQ 2MG BASETABLET / ORALRLD, RS2019-03-26d06236e962d9…
2024-10-29 15:01 UTC2024-10N209884-003MAYZENTEQ 1MG BASETABLET / ORALRLD2021-08-24d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N209884-001MAYZENTEQ 0.25MG BASETABLET / ORALRLD2019-03-2679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N209884-002MAYZENTEQ 2MG BASETABLET / ORALRLD, RS2019-03-2679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N209884-003MAYZENTEQ 1MG BASETABLET / ORALRLD2021-08-2479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N209884-001MAYZENTEQ 0.25MG BASETABLET / ORALRLD2019-03-26301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N209884-002MAYZENTEQ 2MG BASETABLET / ORALRLD, RS2019-03-26301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N209884-003MAYZENTEQ 1MG BASETABLET / ORALRLD2021-08-24301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N209884-001MAYZENTEQ 0.25MG BASETABLET / ORALRLD2019-03-261e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N209884-002MAYZENTEQ 2MG BASETABLET / ORALRLD, RS2019-03-261e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N209884-003MAYZENTEQ 1MG BASETABLET / ORALRLD2021-08-241e350fbaab3a…
2024-05-31 18:47 UTC2024-05N209884-001MAYZENTEQ 0.25MG BASETABLET / ORALRLD2019-03-268072bd15b7f6…

Observed Orange Book patent history#

Patent history page 1 of 8 · 308 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-02-19 14:30 UTC2026-02N209884-00179395192028-08-27Drug substance, Drug product2019-04-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209884-00184924412030-11-30U-25112019-04-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209884-001120714022032-01-05Drug product2024-09-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209884-001119446022036-04-23U-38892024-04-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209884-00279395192028-08-27Drug substance, Drug product2019-04-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209884-00284924412030-11-30U-25112019-04-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209884-002120714022032-01-05Drug product2024-09-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209884-002119446022036-04-23U-38892024-04-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209884-00379395192028-08-27Drug substance, Drug product2021-09-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209884-00384924412030-11-30U-25112021-09-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209884-003120714022032-01-05Drug product2024-09-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209884-003119446022036-04-23U-38892024-04-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N209884-00179395192028-08-27Drug substance, Drug product2019-04-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N209884-00184924412030-11-30U-25112019-04-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N209884-001120714022032-01-05Drug product2024-09-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N209884-001119446022036-04-23U-38892024-04-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N209884-00279395192028-08-27Drug substance, Drug product2019-04-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N209884-00284924412030-11-30U-25112019-04-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N209884-002120714022032-01-05Drug product2024-09-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N209884-002119446022036-04-23U-38892024-04-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N209884-00379395192028-08-27Drug substance, Drug product2021-09-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N209884-00384924412030-11-30U-25112021-09-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N209884-003120714022032-01-05Drug product2024-09-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N209884-003119446022036-04-23U-38892024-04-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08N209884-00179395192028-08-27Drug substance, Drug product2019-04-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08N209884-00184924412030-11-30U-25112019-04-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08N209884-001120714022032-01-05Drug product2024-09-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08N209884-001119446022036-04-23U-38892024-04-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08N209884-00279395192028-08-27Drug substance, Drug product2019-04-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08N209884-00284924412030-11-30U-25112019-04-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08N209884-002120714022032-01-05Drug product2024-09-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08N209884-002119446022036-04-23U-38892024-04-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08N209884-00379395192028-08-27Drug substance, Drug product2021-09-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08N209884-00384924412030-11-30U-25112021-09-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08N209884-003120714022032-01-05Drug product2024-09-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08N209884-003119446022036-04-23U-38892024-04-306a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N209884-00179395192028-08-27Drug substance, Drug product2019-04-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N209884-00184924412030-11-30U-25112019-04-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N209884-001120714022032-01-05Drug product2024-09-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N209884-001119446022036-07-24U-38892024-04-30fd3edfee7708…

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 5 · 178 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N209884-001M-2742025-03-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N209884-002M-2742025-03-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N209884-003M-2742025-03-0131067a03dcf5…
2025-08-23 18:47 UTC2025-08N209884-001M-2742025-03-016a471c1ec25d…
2025-08-23 18:47 UTC2025-08N209884-002M-2742025-03-016a471c1ec25d…
2025-08-23 18:47 UTC2025-08N209884-003M-2742025-03-016a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N209884-001M-2742025-03-01fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N209884-002M-2742025-03-01fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N209884-003M-2742025-03-01fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N209884-001M-2742025-03-01b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N209884-002M-2742025-03-01b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N209884-003M-2742025-03-01b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N209884-001NCE2024-03-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N209884-001M-2742025-03-0103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N209884-002NCE2024-03-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N209884-002M-2742025-03-0103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N209884-003NCE2024-03-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N209884-003M-2742025-03-0103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N209884-001NCE2024-03-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N209884-001M-2742025-03-012680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N209884-002NCE2024-03-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N209884-002M-2742025-03-012680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N209884-003NCE2024-03-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N209884-003M-2742025-03-012680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N209884-001NCE2024-03-265bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N209884-001M-2742025-03-015bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N209884-002NCE2024-03-265bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N209884-002M-2742025-03-015bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N209884-003NCE2024-03-265bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N209884-003M-2742025-03-015bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N209884-001NCE2024-03-26d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N209884-001M-2742025-03-01d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N209884-002NCE2024-03-26d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N209884-002M-2742025-03-01d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N209884-003NCE2024-03-26d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N209884-003M-2742025-03-01d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N209884-001NCE2024-03-26d06236e962d9…
2024-10-29 15:01 UTC2024-10N209884-001M-2742025-03-01d06236e962d9…
2024-10-29 15:01 UTC2024-10N209884-002NCE2024-03-26d06236e962d9…
2024-10-29 15:01 UTC2024-10N209884-002M-2742025-03-01d06236e962d9…

Additional Listing Data#

Finished product
Yes
Brand name base
MAYZENT
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SIPONIMOD.25 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
RR6P8L282IInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 10 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2121090Internal RxNorm lookup
2121096Internal RxNorm lookup
2121098Internal RxNorm lookup
2121100Internal RxNorm lookup
2123313Internal RxNorm lookup
2123314Internal RxNorm lookup
2594606Internal RxNorm lookup
2594608Internal RxNorm lookup
2594796Internal RxNorm lookup
2594797Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
44492772-5aed-4627-bd85-e8e89f308bb3Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
015bcce2-91d4-4c7b-b48c-ea536d3b44acProduct name120190701

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
0078-0979-122023-08-01These 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
0078-0979-122023-08-01These 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
0078-0979-502023-08-01These 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
0078-0979-502023-08-01These 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
0078-0979-892023-08-01These 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
0078-0979-892023-08-01These 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
0078-0979-922023-08-01These 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
0078-0979-922023-08-01These 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
0078-0979-122023-07-28These 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
0078-0979-122023-07-28These 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
0078-0979-502023-07-28These 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
0078-0979-502023-07-28These 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
0078-0979-892023-07-28These 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
0078-0979-892023-07-28These 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
0078-0979-922023-07-28These 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
0078-0979-922023-07-28These 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 NDCProductDescriptionFormQuantityStrengthSPL version
0078-0979-12MAYZENT12 in 1 BLISTER PACKTABLET, FILM COATED1216
0078-0979-50MAYZENT28 in 1 BOTTLETABLET, FILM COATED2816
0078-0979-89MAYZENT7 in 1 BLISTER PACKTABLET, FILM COATED716
0078-0979-92MAYZENT28 in 1 BOTTLETABLET, FILM COATED2816

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0078-0979-12EA - Each0078-0979242d3daa-0194-4647-8bb7-e24c0431046d12019-04-11
0078-0979-50EA - Each0078-09795dd1cb67-74ba-4939-950a-b1f1c0e2a43712019-04-11
0078-0979-89EA - Each0078-0979dadce8f0-a812-44f1-9be3-9ff308d4c2fc12022-04-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0078-0979MAYZENT (SIPONIMOD) TABLET, FILM COATED [NOVARTIS PHARMACEUTICALS CORPORATION]14Current NDC, Legacy NDC, 4 package rows20240724_44492772-5aed-4627-bd85-e8e89f308bb3.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MAYZENTSIPONIMODNovartis Pharmaceuticals Corporation44492772-5aed-4627-bd85-e8e89f308bb32026-06-30Warnings, Adverse reactionsExact identifier
application applno (NDA): 209884
application number: NDA209884
ndc (product): 0078-0979

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2123314{12 (siponimod 0.25 MG Oral Tablet [Mayzent]) } Pack [Mayzent 2 MG Starter Pack]BPCK44492772-5aed-4627-bd85-e8e89f308bb316
2594797{7 (siponimod 0.25 MG Oral Tablet [Mayzent]) } Pack [Mayzent 1 MG Starter Pack]BPCK44492772-5aed-4627-bd85-e8e89f308bb316
2123313{12 (siponimod 0.25 MG Oral Tablet) } PackGPCK44492772-5aed-4627-bd85-e8e89f308bb316
2594796{7 (siponimod 0.25 MG Oral Tablet) } PackGPCK44492772-5aed-4627-bd85-e8e89f308bb316
2121096MAYZENT 0.25 MG Oral TabletPSN44492772-5aed-4627-bd85-e8e89f308bb316
2594608MAYZENT 1 MG Oral TabletPSN44492772-5aed-4627-bd85-e8e89f308bb316
2594797Mayzent 1 MG Starter PackPSN44492772-5aed-4627-bd85-e8e89f308bb316
2121100MAYZENT 2 MG Oral TabletPSN44492772-5aed-4627-bd85-e8e89f308bb316
2123314Mayzent 2 MG Starter PackPSN44492772-5aed-4627-bd85-e8e89f308bb316
2123313siponimod 0.25 MG (12) Oral Tablet PackPSN44492772-5aed-4627-bd85-e8e89f308bb316
2594796siponimod 0.25 MG (7) Oral Tablet PackPSN44492772-5aed-4627-bd85-e8e89f308bb316
2121090siponimod 0.25 MG Oral TabletPSN44492772-5aed-4627-bd85-e8e89f308bb316
2594606siponimod 1 MG Oral TabletPSN44492772-5aed-4627-bd85-e8e89f308bb316
2121098siponimod 2 MG Oral TabletPSN44492772-5aed-4627-bd85-e8e89f308bb316
2121096siponimod 0.25 MG Oral Tablet [Mayzent]SBD44492772-5aed-4627-bd85-e8e89f308bb316
2594608siponimod 1 MG Oral Tablet [Mayzent]SBD44492772-5aed-4627-bd85-e8e89f308bb316
2121100siponimod 2 MG Oral Tablet [Mayzent]SBD44492772-5aed-4627-bd85-e8e89f308bb316
2121090siponimod 0.25 MG Oral TabletSCD44492772-5aed-4627-bd85-e8e89f308bb316
2594606siponimod 1 MG Oral TabletSCD44492772-5aed-4627-bd85-e8e89f308bb316
2121098siponimod 2 MG Oral TabletSCD44492772-5aed-4627-bd85-e8e89f308bb316
2121096Mayzent 0.25 MG Oral TabletSY44492772-5aed-4627-bd85-e8e89f308bb316
2594608Mayzent 1 MG Oral TabletSY44492772-5aed-4627-bd85-e8e89f308bb316
2594797Mayzent 1 MG Starter PackSY44492772-5aed-4627-bd85-e8e89f308bb316
2121100Mayzent 2 MG Oral TabletSY44492772-5aed-4627-bd85-e8e89f308bb316
2123314Mayzent 2 MG Starter PackSY44492772-5aed-4627-bd85-e8e89f308bb316
2594796siponimod 0.25 MG (7) Oral Tablet PackSY44492772-5aed-4627-bd85-e8e89f308bb316

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0078-0979-120007809791212 TABLET, FILM COATED in 1 BLISTER PACK (0078-0979-12) 2019-03-260000-00-00NoNoCurrent
0078-0979-500007809795028 TABLET, FILM COATED in 1 BOTTLE (0078-0979-50) 2019-03-260000-00-00NoNoCurrent
0078-0979-89000780979897 TABLET, FILM COATED in 1 BLISTER PACK (0078-0979-89) 2022-03-010000-00-00NoNoCurrent
0078-0979-920007809799228 TABLET, FILM COATED in 1 BOTTLE (0078-0979-92) 2019-03-260000-00-00YesNoCurrent