Prescription drug · BLA
Rolvedon (Eflapegrastim-xnst) NDC 76961-101
Eflapegrastim 13.2 mg/.6mL · Injection, Solution · Subcutaneous · Spectrum Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 76961-101-01 | 7696101010176961010101 | .6 mL in 1 SYRINGE, GLASS (76961-101-01)Marketed from Oct 18, 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)
- Rolvedon
- Generic name (nonproprietary)
- eflapegrastim-xnst
- Active ingredients
- Eflapegrastim — 13.2 mg/.6mL
- Dosage form
- Injection, Solution
- Route
- Subcutaneous
- Labeler
- Spectrum Pharmaceuticals, Inc.NDC labeler code 76961
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 761148
- Marketing start
- Marketing end
- Other FDA classes
- Granulocyte Colony-Stimulating Factor (Chemical structure)Increased Myeloid Cell Production (Physiologic effect)
- Identifiers
- Product ID 76961-101_9209fc63-aee3-43dc-9bc6-16c5ed73d858SPL ID 9209fc63-aee3-43dc-9bc6-16c5ed73d858SPL set ID 6e436115-62e7-4729-aeb0-ff78ea685206RxCUI 2612541, 2612547UNII UT99UG9QJX
- Pharmacologic class
- Leukocyte Growth Factor
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
N476961010101followed by a unit qualifier and the quantityPackage 76961-0101-01. 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)
Rolvedon is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in adult patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with clinically significant incidence of febrile neutropenia. Limitations of Use Rolvedon is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation. Rolvedon is a leukocyte growth factor indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in adult patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with clinically significant incidence of febrile neutrop…
Excerpt only. Read the full label for complete information.
About NDC 76961-101
- What is NDC 76961-101?
- 76961-101 is the product NDC for Rolvedon (eflapegrastim-xnst), Eflapegrastim 13.2 mg/.6mL injection, solution, listed with the FDA by Spectrum Pharmaceuticals, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Rolvedon (Eflapegrastim-xnst).
- What is the active ingredient?
- Eflapegrastim.
- Who is the labeler?
- Spectrum Pharmaceuticals, Inc., NDC labeler code 76961. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Rolvedon?
- 1 other product NDC are listed under this name. See all Rolvedon NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Rolvedon products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Rolvedoneflapegrastim-xnst | Eflapegrastim 13.2 mg/.6mL | Injection, SolutionSubcutaneous | Assertio Specialty Pharmaceuticals, LLC | 82497-132 | 82497-0132-01 |
Other NDCs under BLA 761148
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 |
|---|---|---|---|---|
| Rolvedoneflapegrastim-xnst | Eflapegrastim 13.2 mg/.6mL | Injection, SolutionSubcutaneous | Assertio Specialty Pharmaceuticals, LLC | 82497-132 |