ZEPOSIA

Product NDC: 59572-820
Requested package NDC: 59572-820-97
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
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	59572-820	59572-820-97	D	Discontinued by firm		2026-08-10

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 date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`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-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N209899-001	ZEPOSIA	OZANIMOD HYDROCHLORIDE	EQ 0.23MG BASE	CAPSULE / ORAL	RLD	2020-03-25
N209899-002	ZEPOSIA	OZANIMOD HYDROCHLORIDE	EQ 0.46MG BASE	CAPSULE / ORAL	RLD	2020-03-25
N209899-003	ZEPOSIA	OZANIMOD HYDROCHLORIDE	EQ 0.92MG BASE	CAPSULE / ORAL	RLD, RS	2020-03-25

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N209899-001	8796318	2029-05-14		Drug substance, Drug product	2020-04-16
N209899-001	9382217	2029-05-14	U-2774		2020-04-16
N209899-001	10239846	2030-11-15	U-3740		2021-06-22
N209899-001	8481573	2033-03-24	U-2774	Drug substance, Drug product	2020-04-16
N209899-001	11680050	2038-09-30	U-2774	Drug substance, Drug product	2023-11-16
N209899-001	11680050	2038-09-30	U-3740	Drug substance, Drug product	2023-11-16
N209899-002	8796318	2029-05-14		Drug substance, Drug product	2020-04-16
N209899-002	9382217	2029-05-14	U-2774		2020-04-16
N209899-002	10239846	2030-11-15	U-3740		2021-06-22
N209899-002	8481573	2033-03-24	U-2774	Drug substance, Drug product	2020-04-16
N209899-002	11680050	2038-09-30	U-2774	Drug substance, Drug product	2023-11-16
N209899-002	11680050	2038-09-30	U-3740	Drug substance, Drug product	2023-11-16
N209899-003	8796318	2029-05-14		Drug substance, Drug product	2020-04-16
N209899-003	9382217	2029-05-14	U-2774		2020-04-16
N209899-003	10239846	2030-11-15	U-3740		2021-06-22
N209899-003	8481573	2033-03-24	U-2774	Drug substance, Drug product	2020-04-16
N209899-003	11680050	2038-09-30	U-2774	Drug substance, Drug product	2023-11-16
N209899-003	11680050	2038-09-30	U-3740	Drug substance, Drug product	2023-11-16

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N209899-001	M-309	2027-08-30
N209899-002	M-309	2027-08-30
N209899-003	M-309	2027-08-30

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
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N209899-001	ZEPOSIA	EQ 0.23MG BASE	CAPSULE / ORAL	RLD	2020-03-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209899-002	ZEPOSIA	EQ 0.46MG BASE	CAPSULE / ORAL	RLD	2020-03-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209899-003	ZEPOSIA	EQ 0.92MG BASE	CAPSULE / ORAL	RLD, RS	2020-03-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209899-001	ZEPOSIA	EQ 0.23MG BASE	CAPSULE / ORAL	RLD	2020-03-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209899-002	ZEPOSIA	EQ 0.46MG BASE	CAPSULE / ORAL	RLD	2020-03-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209899-003	ZEPOSIA	EQ 0.92MG BASE	CAPSULE / ORAL	RLD, RS	2020-03-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N209899-001	ZEPOSIA	EQ 0.23MG BASE	CAPSULE / ORAL	RLD	2020-03-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209899-002	ZEPOSIA	EQ 0.46MG BASE	CAPSULE / ORAL	RLD	2020-03-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209899-003	ZEPOSIA	EQ 0.92MG BASE	CAPSULE / ORAL	RLD, RS	2020-03-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209899-001	ZEPOSIA	EQ 0.23MG BASE	CAPSULE / ORAL	RLD	2020-03-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209899-002	ZEPOSIA	EQ 0.46MG BASE	CAPSULE / ORAL	RLD	2020-03-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209899-003	ZEPOSIA	EQ 0.92MG BASE	CAPSULE / ORAL	RLD, RS	2020-03-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209899-001	ZEPOSIA	EQ 0.23MG BASE	CAPSULE / ORAL	RLD	2020-03-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209899-002	ZEPOSIA	EQ 0.46MG BASE	CAPSULE / ORAL	RLD	2020-03-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209899-003	ZEPOSIA	EQ 0.92MG BASE	CAPSULE / ORAL	RLD, RS	2020-03-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209899-001	ZEPOSIA	EQ 0.23MG BASE	CAPSULE / ORAL	RLD	2020-03-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209899-002	ZEPOSIA	EQ 0.46MG BASE	CAPSULE / ORAL	RLD	2020-03-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209899-003	ZEPOSIA	EQ 0.92MG BASE	CAPSULE / ORAL	RLD, RS	2020-03-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209899-001	ZEPOSIA	EQ 0.23MG BASE	CAPSULE / ORAL	RLD	2020-03-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209899-002	ZEPOSIA	EQ 0.46MG BASE	CAPSULE / ORAL	RLD	2020-03-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209899-003	ZEPOSIA	EQ 0.92MG BASE	CAPSULE / ORAL	RLD, RS	2020-03-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209899-001	ZEPOSIA	EQ 0.23MG BASE	CAPSULE / ORAL	RLD	2020-03-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209899-002	ZEPOSIA	EQ 0.46MG BASE	CAPSULE / ORAL	RLD	2020-03-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209899-003	ZEPOSIA	EQ 0.92MG BASE	CAPSULE / ORAL	RLD, RS	2020-03-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209899-001	ZEPOSIA	EQ 0.23MG BASE	CAPSULE / ORAL	RLD	2020-03-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209899-002	ZEPOSIA	EQ 0.46MG BASE	CAPSULE / ORAL	RLD	2020-03-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209899-003	ZEPOSIA	EQ 0.92MG BASE	CAPSULE / ORAL	RLD, RS	2020-03-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N209899-001	ZEPOSIA	EQ 0.23MG BASE	CAPSULE / ORAL	RLD	2020-03-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N209899-002	ZEPOSIA	EQ 0.46MG BASE	CAPSULE / ORAL	RLD	2020-03-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N209899-003	ZEPOSIA	EQ 0.92MG BASE	CAPSULE / ORAL	RLD, RS	2020-03-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209899-001	ZEPOSIA	EQ 0.23MG BASE	CAPSULE / ORAL	RLD	2020-03-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209899-002	ZEPOSIA	EQ 0.46MG BASE	CAPSULE / ORAL	RLD	2020-03-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209899-003	ZEPOSIA	EQ 0.92MG BASE	CAPSULE / ORAL	RLD, RS	2020-03-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N209899-001	ZEPOSIA	EQ 0.23MG BASE	CAPSULE / ORAL	RLD	2020-03-25	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N209899-002	ZEPOSIA	EQ 0.46MG BASE	CAPSULE / ORAL	RLD	2020-03-25	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N209899-003	ZEPOSIA	EQ 0.92MG BASE	CAPSULE / ORAL	RLD, RS	2020-03-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N209899-001	ZEPOSIA	EQ 0.23MG BASE	CAPSULE / ORAL	RLD	2020-03-25	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N209899-002	ZEPOSIA	EQ 0.46MG BASE	CAPSULE / ORAL	RLD	2020-03-25	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N209899-003	ZEPOSIA	EQ 0.92MG BASE	CAPSULE / ORAL	RLD, RS	2020-03-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N209899-001	ZEPOSIA	EQ 0.23MG BASE	CAPSULE / ORAL	RLD	2020-03-25	`8072bd15b7f6…`

Observed Orange Book patent history#

Patent history page 1 of 14 · 540 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N209899-001	8796318	2029-05-14		Drug substance, Drug product	2020-04-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209899-001	9382217	2029-05-14	U-2774		2020-04-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209899-001	10239846	2030-11-15	U-3740		2021-06-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209899-001	8481573	2033-03-24	U-2774	Drug substance, Drug product	2020-04-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209899-001	11680050	2038-09-30	U-2774	Drug substance, Drug product	2023-11-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209899-001	11680050	2038-09-30	U-3740	Drug substance, Drug product	2023-11-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209899-002	8796318	2029-05-14		Drug substance, Drug product	2020-04-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209899-002	9382217	2029-05-14	U-2774		2020-04-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209899-002	10239846	2030-11-15	U-3740		2021-06-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209899-002	8481573	2033-03-24	U-2774	Drug substance, Drug product	2020-04-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209899-002	11680050	2038-09-30	U-2774	Drug substance, Drug product	2023-11-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209899-002	11680050	2038-09-30	U-3740	Drug substance, Drug product	2023-11-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209899-003	8796318	2029-05-14		Drug substance, Drug product	2020-04-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209899-003	9382217	2029-05-14	U-2774		2020-04-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209899-003	10239846	2030-11-15	U-3740		2021-06-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209899-003	8481573	2033-03-24	U-2774	Drug substance, Drug product	2020-04-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209899-003	11680050	2038-09-30	U-2774	Drug substance, Drug product	2023-11-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209899-003	11680050	2038-09-30	U-3740	Drug substance, Drug product	2023-11-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209899-001	8796318	2029-05-14		Drug substance, Drug product	2020-04-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209899-001	9382217	2029-05-14	U-2774		2020-04-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209899-001	10239846	2030-11-15	U-3740		2021-06-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209899-001	8481573	2033-03-24	U-2774	Drug substance, Drug product	2020-04-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209899-001	11680050	2038-09-30	U-2774	Drug substance, Drug product	2023-11-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209899-001	11680050	2038-09-30	U-3740	Drug substance, Drug product	2023-11-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209899-002	8796318	2029-05-14		Drug substance, Drug product	2020-04-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209899-002	9382217	2029-05-14	U-2774		2020-04-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209899-002	10239846	2030-11-15	U-3740		2021-06-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209899-002	8481573	2033-03-24	U-2774	Drug substance, Drug product	2020-04-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209899-002	11680050	2038-09-30	U-2774	Drug substance, Drug product	2023-11-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209899-002	11680050	2038-09-30	U-3740	Drug substance, Drug product	2023-11-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209899-003	8796318	2029-05-14		Drug substance, Drug product	2020-04-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209899-003	9382217	2029-05-14	U-2774		2020-04-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209899-003	10239846	2030-11-15	U-3740		2021-06-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209899-003	8481573	2033-03-24	U-2774	Drug substance, Drug product	2020-04-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209899-003	11680050	2038-09-30	U-2774	Drug substance, Drug product	2023-11-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209899-003	11680050	2038-09-30	U-3740	Drug substance, Drug product	2023-11-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N209899-001	8796318	2029-05-14		Drug substance, Drug product	2020-04-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209899-001	9382217	2029-05-14	U-2774		2020-04-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209899-001	10239846	2030-11-15	U-3740		2021-06-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209899-001	8481573	2033-03-24	U-2774	Drug substance, Drug product	2020-04-16	`6a471c1ec25d…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 6 · 213 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N209899-001	M-309	2027-08-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209899-002	M-309	2027-08-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209899-003	M-309	2027-08-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209899-001	NCE	2025-03-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209899-001	M-309	2027-08-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209899-002	NCE	2025-03-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209899-002	M-309	2027-08-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209899-003	NCE	2025-03-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209899-003	M-309	2027-08-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N209899-001	NCE	2025-03-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209899-001	M-309	2027-08-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209899-002	NCE	2025-03-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209899-002	M-309	2027-08-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209899-003	NCE	2025-03-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209899-003	M-309	2027-08-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209899-001	NCE	2025-03-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209899-001	M-309	2027-08-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209899-002	NCE	2025-03-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209899-002	M-309	2027-08-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209899-003	NCE	2025-03-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209899-003	M-309	2027-08-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209899-001	NCE	2025-03-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209899-001	M-309	2027-08-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209899-002	NCE	2025-03-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209899-002	M-309	2027-08-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209899-003	NCE	2025-03-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209899-003	M-309	2027-08-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209899-001	I-860	2024-05-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209899-001	NCE	2025-03-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209899-001	M-309	2027-08-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209899-002	I-860	2024-05-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209899-002	NCE	2025-03-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209899-002	M-309	2027-08-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209899-003	I-860	2024-05-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209899-003	NCE	2025-03-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209899-003	M-309	2027-08-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209899-001	I-860	2024-05-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209899-001	NCE	2025-03-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209899-001	M-309	2027-08-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209899-002	I-860	2024-05-27	`2680178bc6a6…`

Additional Listing Data#

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

Active Ingredients#

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
3UPR33JAAM	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 12 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
93ce2fab-edfb-4804-8074-963071de51e4	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
59572-820-30	ZEPOSIA	30 in 1 BOTTLE, PLASTIC	CAPSULE	30		25
59572-820-97	ZEPOSIA	30 in 1 BOTTLE, PLASTIC	CAPSULE	30		25

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
59572-820-30	EA - Each	59572-820	1f7e3b3d-0387-40a6-9e86-6546058f6411	1	2020-06-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
59572-820	ZEPOSIA (OZANIMOD HYDROCHLORIDE) CAPSULE ZEPOSIA 7-DAY STARTER PACK (OZANIMOD HYDROCHLORIDE) KIT ZEPOSIA STARTER KIT (OZANIMOD HYDROCHLORIDE) KIT [CELGENE CORPORATION]	24	Current NDC, Legacy NDC, 2 package rows	20240910_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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ZEPOSIA 7-Day Starter Pack	OZANIMOD HYDROCHLORIDE	Celgene Corporation	93ce2fab-edfb-4804-8074-963071de51e4	2026-04-16	Warnings, Adverse reactions	Exact identifier application applno (NDA): 209899 application number: NDA209899 ndc (package): 59572-820-97 ndc (product): 59572-820 ndc11 (package): 59572082097

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
3UPR33JAAM	OZANIMOD HYDROCHLORIDE	1618636-37-5	OZANIMOD HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2288433	{4 (ozanimod 0.23 MG Oral Capsule [Zeposia]) / 3 (ozanimod 0.46 MG Oral Capsule [Zeposia]) } Pack [Zeposia 7-Day Starter Pack]	BPCK	93ce2fab-edfb-4804-8074-963071de51e4	25
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]	BPCK	93ce2fab-edfb-4804-8074-963071de51e4	25
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]	BPCK	93ce2fab-edfb-4804-8074-963071de51e4	25
2288432	{4 (ozanimod 0.23 MG Oral Capsule) / 3 (ozanimod 0.46 MG Oral Capsule) } Pack	GPCK	93ce2fab-edfb-4804-8074-963071de51e4	25
2642213	{4 (ozanimod 0.23 MG Oral Capsule) / 3 (ozanimod 0.46 MG Oral Capsule) / 21 (ozanimod 0.92 MG Oral Capsule) } Pack	GPCK	93ce2fab-edfb-4804-8074-963071de51e4	25
2288430	{4 (ozanimod 0.23 MG Oral Capsule) / 3 (ozanimod 0.46 MG Oral Capsule) / 30 (ozanimod 0.92 MG Oral Capsule) } Pack	GPCK	93ce2fab-edfb-4804-8074-963071de51e4	25
2288414	ozanimod 0.23 MG Oral Capsule	PSN	93ce2fab-edfb-4804-8074-963071de51e4	25
2288418	ozanimod 0.46 MG Oral Capsule	PSN	93ce2fab-edfb-4804-8074-963071de51e4	25
2288406	ozanimod 0.92 MG Oral Capsule	PSN	93ce2fab-edfb-4804-8074-963071de51e4	25
2642213	ozanimod 28-Day Starter Kit	PSN	93ce2fab-edfb-4804-8074-963071de51e4	25
2288430	ozanimod 37-Day Starter Kit	PSN	93ce2fab-edfb-4804-8074-963071de51e4	25
2288432	ozanimod 7-Day Starter Pack	PSN	93ce2fab-edfb-4804-8074-963071de51e4	25
2288416	ZEPOSIA 0.23 MG Oral Capsule	PSN	93ce2fab-edfb-4804-8074-963071de51e4	25
2288420	ZEPOSIA 0.46 MG Oral Capsule	PSN	93ce2fab-edfb-4804-8074-963071de51e4	25
2288412	ZEPOSIA 0.92 MG Oral Capsule	PSN	93ce2fab-edfb-4804-8074-963071de51e4	25
2642214	ZEPOSIA 28-Day Starter Kit	PSN	93ce2fab-edfb-4804-8074-963071de51e4	25
2288431	ZEPOSIA 37-Day Starter Kit	PSN	93ce2fab-edfb-4804-8074-963071de51e4	25
2288433	ZEPOSIA 7-Day Starter Pack	PSN	93ce2fab-edfb-4804-8074-963071de51e4	25
2288416	ozanimod 0.23 MG Oral Capsule [Zeposia]	SBD	93ce2fab-edfb-4804-8074-963071de51e4	25
2288420	ozanimod 0.46 MG Oral Capsule [Zeposia]	SBD	93ce2fab-edfb-4804-8074-963071de51e4	25
2288412	ozanimod 0.92 MG Oral Capsule [Zeposia]	SBD	93ce2fab-edfb-4804-8074-963071de51e4	25
2288414	ozanimod 0.23 MG Oral Capsule	SCD	93ce2fab-edfb-4804-8074-963071de51e4	25
2288418	ozanimod 0.46 MG Oral Capsule	SCD	93ce2fab-edfb-4804-8074-963071de51e4	25
2288406	ozanimod 0.92 MG Oral Capsule	SCD	93ce2fab-edfb-4804-8074-963071de51e4	25
2288414	ozanimod 0.23 MG (as ozanimod hydrochloride 0.25 MG) Oral Capsule	SY	93ce2fab-edfb-4804-8074-963071de51e4	25
2288418	ozanimod 0.46 MG (as ozanimod hydrochloride 0.5 MG) Oral Capsule	SY	93ce2fab-edfb-4804-8074-963071de51e4	25
2288406	ozanimod 0.92 MG (as ozanimod hydrochloride 1 MG) Oral Capsule	SY	93ce2fab-edfb-4804-8074-963071de51e4	25
2642213	ozanimod 28-Day Starter Kit (7-Day Starter Pack and 0.92 MG 21 count Bottle)	SY	93ce2fab-edfb-4804-8074-963071de51e4	25
2288430	ozanimod 37-Day Starter Kit (7-Day Starter Pack and 0.92 MG 30 count Bottle)	SY	93ce2fab-edfb-4804-8074-963071de51e4	25
2288432	ozanimod 7-Day Starter Pack	SY	93ce2fab-edfb-4804-8074-963071de51e4	25
2288416	Zeposia 0.23 MG Oral Capsule	SY	93ce2fab-edfb-4804-8074-963071de51e4	25
2288420	Zeposia 0.46 MG Oral Capsule	SY	93ce2fab-edfb-4804-8074-963071de51e4	25
2288412	Zeposia 0.92 MG Oral Capsule	SY	93ce2fab-edfb-4804-8074-963071de51e4	25
2642214	Zeposia 28-Day Starter Kit (7-Day Starter Pack and 0.92 MG 21 count Bottle)	SY	93ce2fab-edfb-4804-8074-963071de51e4	25
2288431	Zeposia 37-Day Starter Kit (7-Day Starter Pack and 0.92 MG 30 count Bottle)	SY	93ce2fab-edfb-4804-8074-963071de51e4	25
2288433	Zeposia 7-Day Starter Pack	SY	93ce2fab-edfb-4804-8074-963071de51e4	25

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
59572-820-97	59572082097	30 CAPSULE in 1 BOTTLE, PLASTIC (59572-820-97)	30 capsule	2020-03-27	0000-00-00	No	No	Current