Prescription drug · ANDA
Bendamustine Hydrochloride NDC 55150-391
Bendamustine hydrochloride 25 mg/5mL · Injection, Powder, Lyophilized, For solution · Intravenous · Eugia US LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 55150-391-01 | 5515003910155150039101 | 1 VIAL, SINGLE-DOSE in 1 CARTON (55150-391-01) / 5 mL in 1 VIAL, SINGLE-DOSEMarketed from Jun 5, 2023 |
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)
- Bendamustine Hydrochloride
- Generic name (nonproprietary)
- bendamustine hydrochloride
- Active ingredients
- Bendamustine hydrochloride — 25 mg/5mL
- Dosage form
- Injection, Powder, Lyophilized, For solution
- Route
- Intravenous
- Labeler
- Eugia US LLCNDC labeler code 55150
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 214739
- Marketing start
- Listing expires
- Other FDA classes
- Alkylating Activity (Mechanism)
- Identifiers
- Product ID 55150-391_4357b1f0-fcc2-448a-9580-13b55ba470deSPL ID 4357b1f0-fcc2-448a-9580-13b55ba470deSPL set ID dbe34bc1-06b2-493f-8859-e8b143357aa8RxCUI 1805001, 1805007UNII 981Y8SX18MUPC 0355150391011
- 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
N455150039101followed by a unit qualifier and the quantityPackage 55150-0391-01. 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)
Bendamustine hydrochloride for 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) Bendamustine hydrochloride for injection 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) Bendamustine hyd…
Excerpt only. Read the full label for complete information.
About NDC 55150-391
- What is NDC 55150-391?
- 55150-391 is the product NDC for Bendamustine Hydrochloride, Bendamustine hydrochloride 25 mg/5mL injection, powder, lyophilized, for solution, listed with the FDA by Eugia US LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Bendamustine Hydrochloride.
- What is the active ingredient?
- Bendamustine hydrochloride.
- Who is the labeler?
- Eugia US LLC, NDC labeler code 55150. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Bendamustine Hydrochloride?
- 7 other product NDCs are listed under this name. See all Bendamustine Hydrochloride NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Bendamustine Hydrochloride products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Bendamustine Hydrochloride | Bendamustine hydrochloride 100 mg/4mL | InjectionIntravenous | Avyxa Pharma, LLC | 83831-183 | 83831-0183-04 |
| bendamustine hydrochloride | Bendamustine hydrochloride 100 mg/20mL | Injection, Powder, Lyophilized, For solutionIntravenous | BluePoint Laboratories | 68001-572 | 68001-0572-41 |
| Bendamustine Hydrochloride | Bendamustine hydrochloride 100 mg/20mL | Injection, Powder, Lyophilized, For solutionIntravenous | Eugia US LLC | 55150-392 | 55150-0392-01 |
| Bendamustine Hydrochloride | Bendamustine hydrochloride 25 mg/mL | Injection, SolutionIntravenous | Apotex Corp | 60505-6228 | 60505-6228-00 |
| Bendamustine Hydrochloride | Bendamustine hydrochloride 100 mg/1 | InjectionIntravenous | Baxter Healthcare Corporation | 10019-079 | 10019-0079-01 |
| bendamustine hydrochloride | Bendamustine hydrochloride 25 mg/5mL | Injection, Powder, Lyophilized, For solutionIntravenous | Accord Healthcare, Inc. | 16729-250 | 16729-0250-03 |
| bendamustine hydrochloride | Bendamustine hydrochloride 100 mg/20mL | Injection, Powder, Lyophilized, For solutionIntravenous | Accord Healthcare, Inc. | 16729-251 | 16729-0251-05 |
Other NDCs under ANDA 214739
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 |
|---|---|---|---|---|
| Bendamustine Hydrochloride | Bendamustine hydrochloride 100 mg/20mL | Injection, Powder, Lyophilized, For solutionIntravenous | Eugia US LLC | 55150-392 |