Prescription drug · NDA
ZEPOSIA 7-Day Starter Pack (Ozanimod hydrochloride) NDC 59572-810
Kit · Celgene Corporation
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 59572-810-07 | 59572081007 | 1 KIT in 1 BLISTER PACK (59572-810-07) * 1 CAPSULE in 1 BLISTER PACK * 1 CAPSULE in 1 BLISTER PACKMarketed from Mar 27, 2020 | |
| 59572-810-97 | 59572081097 | 1 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
N459572081007followed by a unit qualifier and the quantityPackage 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.
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.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Zeposiaozanimod hydrochloride | Ozanimod hydrochloride .92 mg/1 | CapsuleOral | Celgene Corporation | 59572-820 |
| ZEPOSIA Starter Kitozanimod hydrochloride | — | Kit | Celgene Corporation | 59572-890 |