What is NDC 63459-348?

63459-348 is the product NDC for Bendeka (bendamustine hydrochloride), Bendamustine hydrochloride 25 mg/mL injection, solution, listed with the FDA by Teva Pharmaceuticals USA, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

Bendeka (Bendamustine hydrochloride).

Teva Pharmaceuticals USA, Inc., 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 Bendeka?

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.

Bendeka NDC 63459-348 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)63459-348Labeler and product segments. Claims need a package NDC.

Product NDC at billing width63459-0348Add 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 NDC	11-digit (billing)	Package	Copy
63459-348-04	6345903480463459034804	1 VIAL, MULTI-DOSE in 1 CARTON (63459-348-04) / 4 mL in 1 VIAL, MULTI-DOSEMarketed from Dec 8, 2015

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): Bendeka
Generic name (nonproprietary): bendamustine hydrochloride
Active ingredients: Bendamustine hydrochloride — 25 mg/mL
Dosage form: Injection, Solution
Route: Intravenous
Labeler: Teva Pharmaceuticals USA, Inc.NDC labeler code 63459
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 208194
Marketing start: Dec 8, 2015
Listing expires: Dec 31, 2026
Other FDA classes: Alkylating Activity (Mechanism)
Identifiers: Product ID 63459-348_bcfd315e-9ade-4659-9f1c-dfb687ba39deSPL ID bcfd315e-9ade-4659-9f1c-dfb687ba39deSPL set ID ace9a43b-f9bd-4896-abfe-0ef4fec67ddfRxCUI 1726097, 1726102UNII 981Y8SX18MUPC 0363459348049
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.

How CPT relates to drug billing

NDC on a medical claim

N463459034804 followed by a unit qualifier and the quantity

Package 63459-0348-04. 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 Jan 19, 2024.

Indications (excerpt from the label)

BENDEKA injection is an alkylating drug indicated for treatment of patients with: Chronic lymphocytic leukemia (CLL). Efficacy relative to first line therapies other than chlorambucil has not been established. ( 1.1 ) Indolent B-cell non-Hodgkin lymphoma (NHL) that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen. ( 1.2 ) 1.1 Chronic Lymphocytic Leukemia (CLL) BENDEKA ® is indicated for the treatment of patients with chronic lymphocytic leukemia. Efficacy relative to first line therapies other than chlorambucil has not been established. 1.2 Non-Hodgkin Lymphoma (NHL) BENDEKA is indicated for the treatment of patients with indolent B-cel…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 63459-348

What is NDC 63459-348?: 63459-348 is the product NDC for Bendeka (bendamustine hydrochloride), Bendamustine hydrochloride 25 mg/mL injection, solution, listed with the FDA by Teva Pharmaceuticals USA, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Bendeka (Bendamustine hydrochloride).
What is the active ingredient?: Bendamustine hydrochloride.
Who is the labeler?: Teva Pharmaceuticals USA, Inc., 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 Bendeka?: 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.

Bendeka (Bendamustine hydrochloride) NDC 63459-348