Prescription drug · NDA
Istodax (Romidepsin) NDC 59572-984
Kit · Celgene Corporation
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 59572-984-01 | 59572098401 | 1 KIT in 1 CARTON (59572-984-01) * 2.2 mL in 1 VIAL, GLASS (59572-962-10) * 2.4 mL in 1 VIAL, GLASS (59572-973-02)Marketed from Jan 4, 2010 |
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)
- Istodax
- Generic name (nonproprietary)
- romidepsin
- Dosage form
- Kit
- Labeler
- Celgene CorporationNDC labeler code 59572
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 022393
- Marketing start
- Listing expires
- Identifiers
- Product ID 59572-984_08c46856-2700-4885-ba5d-dced9d8056e1SPL ID 08c46856-2700-4885-ba5d-dced9d8056e1SPL set ID 03b39d40-90fe-11df-9de6-0002a5d5c51bRxCUI 877513, 877516
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
N459572098401followed by a unit qualifier and the quantityPackage 59572-0984-01. 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)
ISTODAX is indicated for the treatment of cutaneous T-cell lymphoma (CTCL) in adult patients who have received at least one prior systemic therapy. ISTODAX is a histone deacetylase (HDAC) inhibitor indicated for the treatment of cutaneous T-cell lymphoma (CTCL) in adult patients who have received at least one prior systemic therapy ( 1 ).
Excerpt only. Read the full label for complete information.
About NDC 59572-984
- What is NDC 59572-984?
- 59572-984 is the product NDC for Istodax (romidepsin) kit, 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?
- Istodax (Romidepsin).
- 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 Istodax?
- 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.