NDC codes

FDA NDC Directory
Product NDC (as listed)59572-984Labeler and product segments. Claims need a package NDC.
Product NDC at billing width59572-0984Add 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
59572-984-01595720984011 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

N459572098401 followed by a unit qualifier and the quantity

Package 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.

Full label on DailyMed (opens in a new tab)

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.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free Med-Code account to keep looking up NDCs, J-codes and drugs.

Create a free accountLog in