ZEPOSIA

Product NDC
59572-820
11-digit product format
595720820
Labeler code
59572
Product ID
59572-820_4f94fc7c-c65f-6879-e063-6294a90a8217
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ozanimod hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Celgene Corporation
Application
NDA209899
Marketing category
NDA
Marketing start
2020-03-27
Substance
OZANIMOD HYDROCHLORIDE
Active strength
.92 mg/1
Pharmacologic classes
Sphingosine 1-Phosphate Receptor Modulators [MoA], Sphingosine 1-phosphate Receptor Modulator [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage59572-82059572-820-97DDiscontinued by firm2026-08-10

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

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
N209899-001ZEPOSIAOZANIMOD HYDROCHLORIDEEQ 0.23MG BASECAPSULE / ORALRLD2020-03-25
N209899-002ZEPOSIAOZANIMOD HYDROCHLORIDEEQ 0.46MG BASECAPSULE / ORALRLD2020-03-25
N209899-003ZEPOSIAOZANIMOD HYDROCHLORIDEEQ 0.92MG BASECAPSULE / ORALRLD, RS2020-03-25

Orange Book patents#

Current patent rows page 1 of 1 · 18 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N209899-00187963182029-05-14Drug substance, Drug product2020-04-16
N209899-00193822172029-05-14U-27742020-04-16
N209899-001102398462030-11-15U-37402021-06-22
N209899-00184815732033-03-24U-2774Drug substance, Drug product2020-04-16
N209899-001116800502038-09-30U-2774Drug substance, Drug product2023-11-16
N209899-001116800502038-09-30U-3740Drug substance, Drug product2023-11-16
N209899-00287963182029-05-14Drug substance, Drug product2020-04-16
N209899-00293822172029-05-14U-27742020-04-16
N209899-002102398462030-11-15U-37402021-06-22
N209899-00284815732033-03-24U-2774Drug substance, Drug product2020-04-16
N209899-002116800502038-09-30U-2774Drug substance, Drug product2023-11-16
N209899-002116800502038-09-30U-3740Drug substance, Drug product2023-11-16
N209899-00387963182029-05-14Drug substance, Drug product2020-04-16
N209899-00393822172029-05-14U-27742020-04-16
N209899-003102398462030-11-15U-37402021-06-22
N209899-00384815732033-03-24U-2774Drug substance, Drug product2020-04-16
N209899-003116800502038-09-30U-2774Drug substance, Drug product2023-11-16
N209899-003116800502038-09-30U-3740Drug substance, Drug product2023-11-16

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-productExclusivity codeExpiration
N209899-001M-3092027-08-30
N209899-002M-3092027-08-30
N209899-003M-3092027-08-30

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 · 111 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N209899-001ZEPOSIAEQ 0.23MG BASECAPSULE / ORALRLD2020-03-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209899-002ZEPOSIAEQ 0.46MG BASECAPSULE / ORALRLD2020-03-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209899-003ZEPOSIAEQ 0.92MG BASECAPSULE / ORALRLD, RS2020-03-25011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N209899-001ZEPOSIAEQ 0.23MG BASECAPSULE / ORALRLD2020-03-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N209899-002ZEPOSIAEQ 0.46MG BASECAPSULE / ORALRLD2020-03-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N209899-003ZEPOSIAEQ 0.92MG BASECAPSULE / ORALRLD, RS2020-03-2531067a03dcf5…
2025-08-23 18:47 UTC2025-08N209899-001ZEPOSIAEQ 0.23MG BASECAPSULE / ORALRLD2020-03-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08N209899-002ZEPOSIAEQ 0.46MG BASECAPSULE / ORALRLD2020-03-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08N209899-003ZEPOSIAEQ 0.92MG BASECAPSULE / ORALRLD, RS2020-03-256a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N209899-001ZEPOSIAEQ 0.23MG BASECAPSULE / ORALRLD2020-03-25fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N209899-002ZEPOSIAEQ 0.46MG BASECAPSULE / ORALRLD2020-03-25fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N209899-003ZEPOSIAEQ 0.92MG BASECAPSULE / ORALRLD, RS2020-03-25fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N209899-001ZEPOSIAEQ 0.23MG BASECAPSULE / ORALRLD2020-03-25b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N209899-002ZEPOSIAEQ 0.46MG BASECAPSULE / ORALRLD2020-03-25b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N209899-003ZEPOSIAEQ 0.92MG BASECAPSULE / ORALRLD, RS2020-03-25b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N209899-001ZEPOSIAEQ 0.23MG BASECAPSULE / ORALRLD2020-03-2503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N209899-002ZEPOSIAEQ 0.46MG BASECAPSULE / ORALRLD2020-03-2503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N209899-003ZEPOSIAEQ 0.92MG BASECAPSULE / ORALRLD, RS2020-03-2503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N209899-001ZEPOSIAEQ 0.23MG BASECAPSULE / ORALRLD2020-03-252680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N209899-002ZEPOSIAEQ 0.46MG BASECAPSULE / ORALRLD2020-03-252680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N209899-003ZEPOSIAEQ 0.92MG BASECAPSULE / ORALRLD, RS2020-03-252680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N209899-001ZEPOSIAEQ 0.23MG BASECAPSULE / ORALRLD2020-03-255bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N209899-002ZEPOSIAEQ 0.46MG BASECAPSULE / ORALRLD2020-03-255bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N209899-003ZEPOSIAEQ 0.92MG BASECAPSULE / ORALRLD, RS2020-03-255bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N209899-001ZEPOSIAEQ 0.23MG BASECAPSULE / ORALRLD2020-03-25d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N209899-002ZEPOSIAEQ 0.46MG BASECAPSULE / ORALRLD2020-03-25d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N209899-003ZEPOSIAEQ 0.92MG BASECAPSULE / ORALRLD, RS2020-03-25d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N209899-001ZEPOSIAEQ 0.23MG BASECAPSULE / ORALRLD2020-03-25d06236e962d9…
2024-10-29 15:01 UTC2024-10N209899-002ZEPOSIAEQ 0.46MG BASECAPSULE / ORALRLD2020-03-25d06236e962d9…
2024-10-29 15:01 UTC2024-10N209899-003ZEPOSIAEQ 0.92MG BASECAPSULE / ORALRLD, RS2020-03-25d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N209899-001ZEPOSIAEQ 0.23MG BASECAPSULE / ORALRLD2020-03-2579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N209899-002ZEPOSIAEQ 0.46MG BASECAPSULE / ORALRLD2020-03-2579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N209899-003ZEPOSIAEQ 0.92MG BASECAPSULE / ORALRLD, RS2020-03-2579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N209899-001ZEPOSIAEQ 0.23MG BASECAPSULE / ORALRLD2020-03-25301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N209899-002ZEPOSIAEQ 0.46MG BASECAPSULE / ORALRLD2020-03-25301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N209899-003ZEPOSIAEQ 0.92MG BASECAPSULE / ORALRLD, RS2020-03-25301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N209899-001ZEPOSIAEQ 0.23MG BASECAPSULE / ORALRLD2020-03-251e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N209899-002ZEPOSIAEQ 0.46MG BASECAPSULE / ORALRLD2020-03-251e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N209899-003ZEPOSIAEQ 0.92MG BASECAPSULE / ORALRLD, RS2020-03-251e350fbaab3a…
2024-05-31 18:47 UTC2024-05N209899-001ZEPOSIAEQ 0.23MG BASECAPSULE / ORALRLD2020-03-258072bd15b7f6…

Observed Orange Book patent history#

Patent history page 1 of 14 · 540 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-02-19 14:30 UTC2026-02N209899-00187963182029-05-14Drug substance, Drug product2020-04-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209899-00193822172029-05-14U-27742020-04-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209899-001102398462030-11-15U-37402021-06-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209899-00184815732033-03-24U-2774Drug substance, Drug product2020-04-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209899-001116800502038-09-30U-2774Drug substance, Drug product2023-11-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209899-001116800502038-09-30U-3740Drug substance, Drug product2023-11-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209899-00287963182029-05-14Drug substance, Drug product2020-04-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209899-00293822172029-05-14U-27742020-04-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209899-002102398462030-11-15U-37402021-06-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209899-00284815732033-03-24U-2774Drug substance, Drug product2020-04-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209899-002116800502038-09-30U-2774Drug substance, Drug product2023-11-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209899-002116800502038-09-30U-3740Drug substance, Drug product2023-11-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209899-00387963182029-05-14Drug substance, Drug product2020-04-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209899-00393822172029-05-14U-27742020-04-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209899-003102398462030-11-15U-37402021-06-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209899-00384815732033-03-24U-2774Drug substance, Drug product2020-04-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209899-003116800502038-09-30U-2774Drug substance, Drug product2023-11-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209899-003116800502038-09-30U-3740Drug substance, Drug product2023-11-16011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N209899-00187963182029-05-14Drug substance, Drug product2020-04-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N209899-00193822172029-05-14U-27742020-04-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N209899-001102398462030-11-15U-37402021-06-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N209899-00184815732033-03-24U-2774Drug substance, Drug product2020-04-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N209899-001116800502038-09-30U-2774Drug substance, Drug product2023-11-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N209899-001116800502038-09-30U-3740Drug substance, Drug product2023-11-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N209899-00287963182029-05-14Drug substance, Drug product2020-04-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N209899-00293822172029-05-14U-27742020-04-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N209899-002102398462030-11-15U-37402021-06-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N209899-00284815732033-03-24U-2774Drug substance, Drug product2020-04-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N209899-002116800502038-09-30U-2774Drug substance, Drug product2023-11-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N209899-002116800502038-09-30U-3740Drug substance, Drug product2023-11-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N209899-00387963182029-05-14Drug substance, Drug product2020-04-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N209899-00393822172029-05-14U-27742020-04-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N209899-003102398462030-11-15U-37402021-06-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N209899-00384815732033-03-24U-2774Drug substance, Drug product2020-04-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N209899-003116800502038-09-30U-2774Drug substance, Drug product2023-11-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N209899-003116800502038-09-30U-3740Drug substance, Drug product2023-11-1631067a03dcf5…
2025-08-23 18:47 UTC2025-08N209899-00187963182029-05-14Drug substance, Drug product2020-04-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08N209899-00193822172029-05-14U-27742020-04-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08N209899-001102398462030-11-15U-37402021-06-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08N209899-00184815732033-03-24U-2774Drug substance, Drug product2020-04-166a471c1ec25d…

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 6 · 213 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2026-02-19 14:30 UTC2026-02N209899-001M-3092027-08-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209899-002M-3092027-08-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209899-003M-3092027-08-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N209899-001NCE2025-03-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N209899-001M-3092027-08-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N209899-002NCE2025-03-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N209899-002M-3092027-08-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N209899-003NCE2025-03-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N209899-003M-3092027-08-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08N209899-001NCE2025-03-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08N209899-001M-3092027-08-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08N209899-002NCE2025-03-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08N209899-002M-3092027-08-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08N209899-003NCE2025-03-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08N209899-003M-3092027-08-306a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N209899-001NCE2025-03-25fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N209899-001M-3092027-08-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N209899-002NCE2025-03-25fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N209899-002M-3092027-08-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N209899-003NCE2025-03-25fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N209899-003M-3092027-08-30fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N209899-001NCE2025-03-25b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N209899-001M-3092027-08-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N209899-002NCE2025-03-25b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N209899-002M-3092027-08-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N209899-003NCE2025-03-25b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N209899-003M-3092027-08-30b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N209899-001I-8602024-05-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N209899-001NCE2025-03-2503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N209899-001M-3092027-08-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N209899-002I-8602024-05-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N209899-002NCE2025-03-2503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N209899-002M-3092027-08-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N209899-003I-8602024-05-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N209899-003NCE2025-03-2503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N209899-003M-3092027-08-3003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N209899-001I-8602024-05-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N209899-001NCE2025-03-252680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N209899-001M-3092027-08-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N209899-002I-8602024-05-272680178bc6a6…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OZANIMOD HYDROCHLORIDE.92 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
3UPR33JAAMInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 12 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2288406Internal RxNorm lookup
2288412Internal RxNorm lookup
2288414Internal RxNorm lookup
2288416Internal RxNorm lookup
2288418Internal RxNorm lookup
2288420Internal RxNorm lookup
2288430Internal RxNorm lookup
2288431Internal RxNorm lookup
2288432Internal RxNorm lookup
2288433Internal RxNorm lookup
2642213Internal RxNorm lookup
2642214Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
93ce2fab-edfb-4804-8074-963071de51e4Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59572-820-30ZEPOSIA30 in 1 BOTTLE, PLASTICCAPSULE3025
59572-820-97ZEPOSIA30 in 1 BOTTLE, PLASTICCAPSULE3025

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59572-820-30EA - Each59572-8201f7e3b3d-0387-40a6-9e86-6546058f641112020-06-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59572-820ZEPOSIA (OZANIMOD HYDROCHLORIDE) CAPSULE ZEPOSIA 7-DAY STARTER PACK (OZANIMOD HYDROCHLORIDE) KIT ZEPOSIA STARTER KIT (OZANIMOD HYDROCHLORIDE) KIT [CELGENE CORPORATION]24Current NDC, Legacy NDC, 2 package rows20240910_93ce2fab-edfb-4804-8074-963071de51e4.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
ZEPOSIA 7-Day Starter PackOZANIMOD HYDROCHLORIDECelgene Corporation93ce2fab-edfb-4804-8074-963071de51e42026-04-16Warnings, Adverse reactionsExact identifier
application applno (NDA): 209899
application number: NDA209899
ndc (product): 59572-820

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2288433{4 (ozanimod 0.23 MG Oral Capsule [Zeposia]) / 3 (ozanimod 0.46 MG Oral Capsule [Zeposia]) } Pack [Zeposia 7-Day Starter Pack]BPCK93ce2fab-edfb-4804-8074-963071de51e425
2642214{4 (ozanimod 0.23 MG Oral Capsule [Zeposia]) / 3 (ozanimod 0.46 MG Oral Capsule [Zeposia]) / 21 (ozanimod 0.92 MG Oral Capsule [Zeposia]) } Pack [Zeposia 28-Day Starter Kit]BPCK93ce2fab-edfb-4804-8074-963071de51e425
2288431{4 (ozanimod 0.23 MG Oral Capsule [Zeposia]) / 3 (ozanimod 0.46 MG Oral Capsule [Zeposia]) / 30 (ozanimod 0.92 MG Oral Capsule [Zeposia]) } Pack [Zeposia 37-Day Starter Kit]BPCK93ce2fab-edfb-4804-8074-963071de51e425
2288432{4 (ozanimod 0.23 MG Oral Capsule) / 3 (ozanimod 0.46 MG Oral Capsule) } PackGPCK93ce2fab-edfb-4804-8074-963071de51e425
2642213{4 (ozanimod 0.23 MG Oral Capsule) / 3 (ozanimod 0.46 MG Oral Capsule) / 21 (ozanimod 0.92 MG Oral Capsule) } PackGPCK93ce2fab-edfb-4804-8074-963071de51e425
2288430{4 (ozanimod 0.23 MG Oral Capsule) / 3 (ozanimod 0.46 MG Oral Capsule) / 30 (ozanimod 0.92 MG Oral Capsule) } PackGPCK93ce2fab-edfb-4804-8074-963071de51e425
2288414ozanimod 0.23 MG Oral CapsulePSN93ce2fab-edfb-4804-8074-963071de51e425
2288418ozanimod 0.46 MG Oral CapsulePSN93ce2fab-edfb-4804-8074-963071de51e425
2288406ozanimod 0.92 MG Oral CapsulePSN93ce2fab-edfb-4804-8074-963071de51e425
2642213ozanimod 28-Day Starter KitPSN93ce2fab-edfb-4804-8074-963071de51e425
2288430ozanimod 37-Day Starter KitPSN93ce2fab-edfb-4804-8074-963071de51e425
2288432ozanimod 7-Day Starter PackPSN93ce2fab-edfb-4804-8074-963071de51e425
2288416ZEPOSIA 0.23 MG Oral CapsulePSN93ce2fab-edfb-4804-8074-963071de51e425
2288420ZEPOSIA 0.46 MG Oral CapsulePSN93ce2fab-edfb-4804-8074-963071de51e425
2288412ZEPOSIA 0.92 MG Oral CapsulePSN93ce2fab-edfb-4804-8074-963071de51e425
2642214ZEPOSIA 28-Day Starter KitPSN93ce2fab-edfb-4804-8074-963071de51e425
2288431ZEPOSIA 37-Day Starter KitPSN93ce2fab-edfb-4804-8074-963071de51e425
2288433ZEPOSIA 7-Day Starter PackPSN93ce2fab-edfb-4804-8074-963071de51e425
2288416ozanimod 0.23 MG Oral Capsule [Zeposia]SBD93ce2fab-edfb-4804-8074-963071de51e425
2288420ozanimod 0.46 MG Oral Capsule [Zeposia]SBD93ce2fab-edfb-4804-8074-963071de51e425
2288412ozanimod 0.92 MG Oral Capsule [Zeposia]SBD93ce2fab-edfb-4804-8074-963071de51e425
2288414ozanimod 0.23 MG Oral CapsuleSCD93ce2fab-edfb-4804-8074-963071de51e425
2288418ozanimod 0.46 MG Oral CapsuleSCD93ce2fab-edfb-4804-8074-963071de51e425
2288406ozanimod 0.92 MG Oral CapsuleSCD93ce2fab-edfb-4804-8074-963071de51e425
2288414ozanimod 0.23 MG (as ozanimod hydrochloride 0.25 MG) Oral CapsuleSY93ce2fab-edfb-4804-8074-963071de51e425
2288418ozanimod 0.46 MG (as ozanimod hydrochloride 0.5 MG) Oral CapsuleSY93ce2fab-edfb-4804-8074-963071de51e425
2288406ozanimod 0.92 MG (as ozanimod hydrochloride 1 MG) Oral CapsuleSY93ce2fab-edfb-4804-8074-963071de51e425
2642213ozanimod 28-Day Starter Kit (7-Day Starter Pack and 0.92 MG 21 count Bottle)SY93ce2fab-edfb-4804-8074-963071de51e425
2288430ozanimod 37-Day Starter Kit (7-Day Starter Pack and 0.92 MG 30 count Bottle)SY93ce2fab-edfb-4804-8074-963071de51e425
2288432ozanimod 7-Day Starter PackSY93ce2fab-edfb-4804-8074-963071de51e425
2288416Zeposia 0.23 MG Oral CapsuleSY93ce2fab-edfb-4804-8074-963071de51e425
2288420Zeposia 0.46 MG Oral CapsuleSY93ce2fab-edfb-4804-8074-963071de51e425
2288412Zeposia 0.92 MG Oral CapsuleSY93ce2fab-edfb-4804-8074-963071de51e425
2642214Zeposia 28-Day Starter Kit (7-Day Starter Pack and 0.92 MG 21 count Bottle)SY93ce2fab-edfb-4804-8074-963071de51e425
2288431Zeposia 37-Day Starter Kit (7-Day Starter Pack and 0.92 MG 30 count Bottle)SY93ce2fab-edfb-4804-8074-963071de51e425
2288433Zeposia 7-Day Starter PackSY93ce2fab-edfb-4804-8074-963071de51e425

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59572-820-305957208203030 CAPSULE in 1 BOTTLE, PLASTIC (59572-820-30) 30 capsule2020-03-270000-00-00NoNoCurrent
59572-820-975957208209730 CAPSULE in 1 BOTTLE, PLASTIC (59572-820-97) 30 capsule2020-03-270000-00-00NoNoCurrent