NDC codes

FDA NDC Directory
Product NDC (as listed)59572-810Labeler and product segments. Claims need a package NDC.
Product NDC at billing width59572-0810Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
59572-810-07595720810071 KIT in 1 BLISTER PACK (59572-810-07) * 1 CAPSULE in 1 BLISTER PACK * 1 CAPSULE in 1 BLISTER PACKMarketed from Mar 27, 2020
59572-810-97595720810971 KIT in 1 BLISTER PACK (59572-810-97) * 1 CAPSULE in 1 BLISTER PACK * 1 CAPSULE in 1 BLISTER PACKMarketed from Mar 27, 2020

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary)
ZEPOSIA 7-Day Starter PackSuffix: 7-Day Starter Pack
Generic name (nonproprietary)
ozanimod hydrochloride
Dosage form
Kit
Labeler
Celgene CorporationNDC labeler code 59572
Product type
Prescription drug
Marketing category
NDA — New Drug ApplicationApplication NDA 209899
Marketing start
Listing expires
Identifiers
Product ID 59572-810_4f94fc7c-c65f-6879-e063-6294a90a8217SPL ID 4f94fc7c-c65f-6879-e063-6294a90a8217SPL set ID 93ce2fab-edfb-4804-8074-963071de51e4RxCUI 2288406, 2288412, 2288414, 2288416, 2288418, 2288420, 2288430, 2288431, 2288432, 2288433, 2642213, 2642214UNII 3UPR33JAAM

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.

NDC on a medical claim

N459572081007 followed by a unit qualifier and the quantity

Package 59572-0810-07. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective .

Indications (excerpt from the label)

ZEPOSIA is indicated for the treatment of: relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. moderately to severely active ulcerative colitis (UC) in adults. ZEPOSIA is a sphingosine 1-phosphate receptor modulator indicated for the treatment of: Relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. ( 1 ) Moderately to severely active ulcerative colitis (UC) in adults. ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 59572-810

What is NDC 59572-810?
59572-810 is the product NDC for ZEPOSIA 7-Day Starter Pack (ozanimod hydrochloride) kit, listed with the FDA by Celgene Corporation. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
ZEPOSIA 7-Day Starter Pack (Ozanimod hydrochloride).
Who is the labeler?
Celgene Corporation, NDC labeler code 59572. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for ZEPOSIA 7-Day Starter Pack?
None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

Other NDCs under NDA 209899

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under NDA 209899
ProductStrengthForm · routeLabelerProduct NDC
Zeposiaozanimod hydrochlorideOzanimod hydrochloride .92 mg/1CapsuleOralCelgene Corporation59572-820
ZEPOSIA Starter Kitozanimod hydrochloride—KitCelgene Corporation59572-890

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