Prescription drug · NDA
Beleodaq (Belinostat) NDC 72893-002
Belinostat 500 mg/10mL · Injection, Powder, Lyophilized, For solution · Intravenous · Acrotech Biopharma Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72893-002-01 | 7289300020172893000201 | 1 VIAL in 1 CARTON (72893-002-01) / 10 mL in 1 VIALMarketed from Jul 21, 2014 |
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)
- Beleodaq
- Generic name (nonproprietary)
- belinostat
- Active ingredients
- Belinostat — 500 mg/10mL
- Dosage form
- Injection, Powder, Lyophilized, For solution
- Route
- Intravenous
- Labeler
- Acrotech Biopharma IncNDC labeler code 72893
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 206256
- Marketing start
- Listing expires
- Other FDA classes
- Histone Deacetylase Inhibitors (Mechanism)
- Identifiers
- Product ID 72893-002_0af69daf-c3eb-436a-b8d9-8ae89c5f0c85SPL ID 0af69daf-c3eb-436a-b8d9-8ae89c5f0c85SPL set ID 2e8ef36b-71fa-4492-a16f-577d5f7d111dRxCUI 1543547, 1543552UNII F4H96P17NZUPC 0372893002011
- 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 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.
- Administration
Drug administration (CPT 96360–96549)
When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.
- NDC on a medical claim
N472893000201followed by a unit qualifier and the quantityPackage 72893-0002-01. 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)
Beleodaq is indicated for the treatment of adult patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). This indication is approved under accelerated approval based on tumor response rate and duration of response [ see Clinical Studies ( 14 )]. An improvement in survival or disease-related symptoms has not been established. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trial. Beleodaq is a histone deacetylase inhibitor indicated for the treatment of adult patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). This indication is approved under accelerated approval based on tu…
Excerpt only. Read the full label for complete information.
About NDC 72893-002
- What is NDC 72893-002?
- 72893-002 is the product NDC for Beleodaq (belinostat), Belinostat 500 mg/10mL injection, powder, lyophilized, for solution, listed with the FDA by Acrotech Biopharma Inc. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Beleodaq (Belinostat).
- What is the active ingredient?
- Belinostat.
- Who is the labeler?
- Acrotech Biopharma Inc, NDC labeler code 72893. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Beleodaq?
- 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.