FDA.reportPublic FDA data

ZEPOSIA

Product NDC
59572-810
11-digit product format
595720810
Labeler code
59572
Product ID
59572-810_4f94fc7c-c65f-6879-e063-6294a90a8217
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ozanimod hydrochloride
Dosage form
KIT
Labeler
Celgene Corporation
Application
NDA209899
Marketing category
NDA
Marketing start
2020-03-27
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
ZEPOSIA
Brand name suffix
7-Day Starter Pack
Listing expiration
2027-12-31

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3UPR33JAAM
Rxcui2288406, 2288412, 2288414, 2288416, 2288418, 2288420, 2288430, 2288431, 2288432, 2288433, 2642213, 2642214

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59572-810-07ZEPOSIA7-Day Starter Pack1 in 1 BLISTER PACKKIT125
59572-810-97ZEPOSIA7-Day Starter Pack1 in 1 BLISTER PACKKIT125

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59572-810-07EA - Each59572-8106e2644b9-e9bc-4bc2-a349-db8619d5fbf412020-06-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59572-810ZEPOSIA (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

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
59572-810-07595720810071 KIT in 1 BLISTER PACK (59572-810-07) * 1 CAPSULE in 1 BLISTER PACK * 1 CAPSULE in 1 BLISTER PACK1 kit2020-03-270000-00-00NoNoCurrent
59572-810-97595720810971 KIT in 1 BLISTER PACK (59572-810-97) * 1 CAPSULE in 1 BLISTER PACK * 1 CAPSULE in 1 BLISTER PACK1 kit2020-03-270000-00-00NoNoCurrent