NDC codes

FDA NDC Directory
Product NDC (as listed)0006-0568Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00006-0568Add 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
0006-0568-4000006056840120 CAPSULE in 1 BOTTLE (0006-0568-40)Marketed from Oct 6, 2006

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
Zolinza
Generic name (nonproprietary)
vorinostat
Active ingredients
Vorinostat — 100 mg/1
Dosage form
Capsule
Route
Oral
Labeler
Merck Sharp & Dohme LLCNDC labeler code 0006
Product type
Prescription drug
Marketing category
NDA — New Drug ApplicationApplication NDA 021991
Marketing start
Listing expires
Other FDA classes
Histone Deacetylase Inhibitors (Mechanism)
Identifiers
Product ID 0006-0568_27d99e44-bbc6-445d-b08b-e32fd8702dc3SPL ID 27d99e44-bbc6-445d-b08b-e32fd8702dc3SPL set ID cd86ee78-2781-468b-930c-3c4677bcc092RxCUI 668579, 668606UNII 58IFB293JIUPC 0300060568404
Pharmacologic class
Histone Deacetylase Inhibitor

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

N400006056840 followed by a unit qualifier and the quantity

Package 00006-0568-40. 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)

ZOLINZA ® is indicated for the treatment of cutaneous manifestations in patients with cutaneous T-cell lymphoma who have progressive, persistent or recurrent disease on or following two systemic therapies. ZOLINZA is a histone deacetylase (HDAC) inhibitor indicated for the treatment of cutaneous manifestations in patients with cutaneous T-cell lymphoma (CTCL) who have progressive, persistent or recurrent disease on or following two systemic therapies. ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0006-0568

What is NDC 0006-0568?
0006-0568 is the product NDC for Zolinza (vorinostat), Vorinostat 100 mg/1 capsule, listed with the FDA by Merck Sharp & Dohme LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Zolinza (Vorinostat).
What is the active ingredient?
Vorinostat.
Who is the labeler?
Merck Sharp & Dohme LLC, NDC labeler code 0006. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Zolinza?
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.

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