Prescription drug · NDA
Zeposia (Ozanimod hydrochloride) NDC 59572-820
Ozanimod hydrochloride .92 mg/1 · Capsule · Oral · Celgene Corporation
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 59572-820-30 | 59572082030 | 30 CAPSULE in 1 BOTTLE, PLASTIC (59572-820-30)Marketed 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
- Generic name (nonproprietary)
- ozanimod hydrochloride
- Active ingredients
- Ozanimod hydrochloride — .92 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Celgene CorporationNDC labeler code 59572
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 209899
- Marketing start
- Listing expires
- Other FDA classes
- Sphingosine 1-Phosphate Receptor Modulators (Mechanism)
- Identifiers
- Product ID 59572-820_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
- Pharmacologic class
- Sphingosine 1-phosphate Receptor Modulator
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 HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N459572082030followed by a unit qualifier and the quantityPackage 59572-0820-30. 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 59572-820
- What is NDC 59572-820?
- 59572-820 is the product NDC for Zeposia (ozanimod hydrochloride), Ozanimod hydrochloride .92 mg/1 capsule, listed with the FDA by Celgene Corporation. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Zeposia (Ozanimod hydrochloride).
- What is the active ingredient?
- 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?
- 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 |
|---|---|---|---|---|
| ZEPOSIA 7-Day Starter Packozanimod hydrochloride | — | Kit | Celgene Corporation | 59572-810 |
| ZEPOSIA Starter Kitozanimod hydrochloride | — | Kit | Celgene Corporation | 59572-890 |