Prescription drug · NDA
Vivimusta (Bendamustine hydrochloride) NDC 71225-120
Bendamustine hydrochloride 25 mg/mL · Injection · Intravenous · Slayback Pharma LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71225-120-01 | 7122501200171225012001 | 1 VIAL, MULTI-DOSE in 1 CARTON (71225-120-01) / 4 mL in 1 VIAL, MULTI-DOSEMarketed from Dec 7, 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)
- Vivimusta
- Generic name (nonproprietary)
- bendamustine hydrochloride
- Active ingredients
- Bendamustine hydrochloride — 25 mg/mL
- Dosage form
- Injection
- Route
- Intravenous
- Labeler
- Slayback Pharma LLCNDC labeler code 71225
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 212209
- Marketing start
- Listing expires
- Other FDA classes
- Alkylating Activity (Mechanism)
- Identifiers
- Product ID 71225-120_c4b54079-dac2-4e01-a00f-6ceaa788f605SPL ID c4b54079-dac2-4e01-a00f-6ceaa788f605SPL set ID cbcc6eb7-aa62-4599-af49-05203fedb4bbRxCUI 1726097, 2622914UNII 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
N471225012001followed by a unit qualifier and the quantityPackage 71225-0120-01. 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)
VIVIMUSTA 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) VIVIMUSTA 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) VIVIMUSTA is indicated for the treatment of adult patients with indo…
Excerpt only. Read the full label for complete information.
About NDC 71225-120
- What is NDC 71225-120?
- 71225-120 is the product NDC for Vivimusta (bendamustine hydrochloride), Bendamustine hydrochloride 25 mg/mL injection, listed with the FDA by Slayback Pharma LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Vivimusta (Bendamustine hydrochloride).
- What is the active ingredient?
- Bendamustine hydrochloride.
- Who is the labeler?
- Slayback Pharma LLC, NDC labeler code 71225. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Vivimusta?
- 1 other product NDC are listed under this name. See all Vivimusta NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Vivimusta products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Vivimustabendamustine hydrochloride | Bendamustine hydrochloride 25 mg/mL | InjectionIntravenous | Azurity Pharmaceuticals, Inc. | 24338-270 | 24338-0270-01 |
Other NDCs under NDA 212209
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 |
|---|---|---|---|---|
| Vivimustabendamustine hydrochloride | Bendamustine hydrochloride 25 mg/mL | InjectionIntravenous | Azurity Pharmaceuticals, Inc. | 24338-270 |