Prescription drug · NDA
Bendamustine Hydrochloride NDC 10019-079
Bendamustine hydrochloride 100 mg/1 · Injection · Intravenous · Baxter Healthcare Corporation
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 10019-079-01 | 1001900790110019007901 | 1 VIAL, MULTI-DOSE in 1 CARTON (10019-079-01) / 1 INJECTION in 1 VIAL, MULTI-DOSEMarketed from Dec 15, 2022 |
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 — 100 mg/1
- Dosage form
- Injection
- Route
- Intravenous
- Labeler
- Baxter Healthcare CorporationNDC labeler code 10019
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 216078
- Marketing start
- Listing expires
- Other FDA classes
- Alkylating Activity (Mechanism)
- Identifiers
- Product ID 10019-079_007f13c9-9ca3-45f9-bbae-6806681efd06SPL ID 007f13c9-9ca3-45f9-bbae-6806681efd06SPL set ID 766b73e2-49bb-47f9-bbb1-44cfa1a3197eRxCUI 1726097UNII 981Y8SX18M
- 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
N410019007901followed by a unit qualifier and the quantityPackage 10019-0079-01. 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 Injection is an alkylating drug indicated for treatment of adult 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 q Hydrochloride Injection is indicated for the treatment of adult patients with chronic lymphocytic leukemia. Efficacy relative to first line therapies other than chlorambucil has not been established. 1.2 Non-Hodgkin Lymphoma (NHL) Bendam…
Excerpt only. Read the full label for complete information.
About NDC 10019-079
- What is NDC 10019-079?
- 10019-079 is the product NDC for Bendamustine Hydrochloride, Bendamustine hydrochloride 100 mg/1 injection, listed with the FDA by Baxter Healthcare Corporation. 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?
- Baxter Healthcare Corporation, NDC labeler code 10019. 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 25 mg/5mL | Injection, Powder, Lyophilized, For solutionIntravenous | Eugia US LLC | 55150-391 | 55150-0391-01 |
| 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 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 |