Prescription drug · NDA
Zolinza (Vorinostat) NDC 0006-0568
Vorinostat 100 mg/1 · Capsule · Oral · Merck Sharp & Dohme LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0006-0568-40 | 00006056840 | 120 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
N400006056840followed by a unit qualifier and the quantityPackage 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.
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.