zeposia

Generic: ozanimod hydrochloride

Labeler: celgene corporation
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name zeposia
Generic Name ozanimod hydrochloride
Labeler celgene corporation
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

ozanimod hydrochloride .92 mg/1

Manufacturer
Celgene Corporation

Identifiers & Regulatory

Product NDC 59572-820
Product ID 59572-820_47f2242f-a571-48a8-985a-8fa4f79ec12f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA209899
Listing Expiration 2026-12-31
Marketing Start 2020-03-27

Pharmacologic Class

Classes
sphingosine 1-phosphate receptor modulators [moa] sphingosine 1-phosphate receptor modulator [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 59572820
Hyphenated Format 59572-820

Supplemental Identifiers

RxCUI
2288406 2288412 2288414 2288416 2288418 2288420 2288430 2288431 2288432 2288433 2642213 2642214
UNII
3UPR33JAAM

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name zeposia (source: ndc)
Generic Name ozanimod hydrochloride (source: ndc)
Application Number NDA209899 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .92 mg/1
source: ndc
Packaging
  • 30 CAPSULE in 1 BOTTLE, PLASTIC (59572-820-30)
source: ndc

Packages (1)

59572-820-30 30 CAPSULE in 1 BOTTLE, PLASTIC (59572-820-30)

Ingredients (1)

ozanimod hydrochloride (.92 mg/1)

Linked Drug Pages (1)

ZEPOSIA 7-Day Starter Pack, ZEPOSIA, ZEPOSIA Starter Kit ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "47f2242f-a571-48a8-985a-8fa4f79ec12f", "openfda": {"unii": ["3UPR33JAAM"], "rxcui": ["2288406", "2288412", "2288414", "2288416", "2288418", "2288420", "2288430", "2288431", "2288432", "2288433", "2642213", "2642214"], "spl_set_id": ["93ce2fab-edfb-4804-8074-963071de51e4"], "manufacturer_name": ["Celgene Corporation"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE in 1 BOTTLE, PLASTIC (59572-820-30)", "package_ndc": "59572-820-30", "marketing_start_date": "20200327"}], "brand_name": "ZEPOSIA", "product_id": "59572-820_47f2242f-a571-48a8-985a-8fa4f79ec12f", "dosage_form": "CAPSULE", "pharm_class": ["Sphingosine 1-Phosphate Receptor Modulators [MoA]", "Sphingosine 1-phosphate Receptor Modulator [EPC]"], "product_ndc": "59572-820", "generic_name": "ozanimod hydrochloride", "labeler_name": "Celgene Corporation", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ZEPOSIA", "active_ingredients": [{"name": "OZANIMOD HYDROCHLORIDE", "strength": ".92 mg/1"}], "application_number": "NDA209899", "marketing_category": "NDA", "marketing_start_date": "20200327", "listing_expiration_date": "20261231"}