Prescription drug · NDA
Treanda (Bendamustine hydrochloride) NDC 63459-390
Bendamustine hydrochloride 25 mg/5mL · Injection, Powder, Lyophilized, For solution · Intravenous · Cephalon, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63459-390-08 | 6345903900863459039008 | 1 VIAL, SINGLE-DOSE in 1 CARTON (63459-390-08) / 5 mL in 1 VIAL, SINGLE-DOSEMarketed from Jan 5, 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)
- Treanda
- Generic name (nonproprietary)
- bendamustine hydrochloride
- Active ingredients
- Bendamustine hydrochloride — 25 mg/5mL
- Dosage form
- Injection, Powder, Lyophilized, For solution
- Route
- Intravenous
- Labeler
- Cephalon, LLCNDC labeler code 63459
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 022249
- Marketing start
- Listing expires
- Other FDA classes
- Alkylating Activity (Mechanism)
- Identifiers
- Product ID 63459-390_6f14f826-ae33-48f7-8a5a-413412030c2dSPL ID 6f14f826-ae33-48f7-8a5a-413412030c2d
- Pharmacologic class
- Alkylating Drug
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
N463459039008followed by a unit qualifier and the quantityPackage 63459-0390-08. 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
The FDA listing for this product does not reference a label (SPL) set.
About NDC 63459-390
- What is NDC 63459-390?
- 63459-390 is the product NDC for Treanda (bendamustine hydrochloride), Bendamustine hydrochloride 25 mg/5mL injection, powder, lyophilized, for solution, listed with the FDA by Cephalon, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Treanda (Bendamustine Hydrochloride).
- What is the active ingredient?
- Bendamustine hydrochloride.
- Who is the labeler?
- Cephalon, LLC, NDC labeler code 63459. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Treanda?
- 1 other product NDC are listed under this name. See all Treanda NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Treanda products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Treandabendamustine hydrochloride | Bendamustine hydrochloride 100 mg/20mL | Injection, Powder, Lyophilized, For solutionIntravenous | Cephalon, LLC | 63459-391 | 63459-0391-20 |
Other NDCs under NDA 022249
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Treandabendamustine hydrochloride | Bendamustine hydrochloride 100 mg/20mL | Injection, Powder, Lyophilized, For solutionIntravenous | Cephalon, LLC | 63459-391 |