Prescription drug · BLA
Granix (Tbo-filgrastim) NDC 63459-920
Filgrastim 480 ug/1.6mL · Injection, Solution · Subcutaneous · Cephalon, LLC
NDC codes
FDA NDC DirectoryProduct information
- Brand name (proprietary)
- Granix
- Generic name (nonproprietary)
- tbo-filgrastim
- Active ingredients
- Filgrastim — 480 ug/1.6mL
- Dosage form
- Injection, Solution
- Route
- Subcutaneous
- Labeler
- Cephalon, LLCNDC labeler code 63459
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 125294
- Marketing start
- Listing expires
- Other FDA classes
- Granulocyte Colony-Stimulating Factor (Chemical structure)Increased Myeloid Cell Production (Physiologic effect)
- Identifiers
- Product ID 63459-920_bebf458b-946a-4cc0-b565-5e2637f48cb2SPL ID bebf458b-946a-4cc0-b565-5e2637f48cb2
- 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.
Product label
The FDA listing for this product does not reference a label (SPL) set.
About NDC 63459-920
- What is NDC 63459-920?
- 63459-920 is the product NDC for Granix (tbo-filgrastim), Filgrastim 480 ug/1.6mL injection, solution, listed with the FDA by Cephalon, LLC.
- What drug is associated with this NDC?
- Granix (Tbo-filgrastim).
- What is the active ingredient?
- Filgrastim.
- Who is the labeler?
- Cephalon, LLC, 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 Granix?
- 3 other product NDCs are listed under this name. See all Granix NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Granix products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Granixtbo-filgrastim | Filgrastim 300 ug/mL | Injection, SolutionSubcutaneous | Cephalon, LLC | 63459-918 | 63459-0918-59 |
| Granixtbo-filgrastim | Filgrastim 300 ug/.5mL | Injection, SolutionSubcutaneous | Cephalon, LLC | 63459-910 | 63459-0910-1163459-0910-1563459-0910-17+1 more |
| Granixtbo-filgrastim | Filgrastim 480 ug/.8mL | Injection, SolutionSubcutaneous | Cephalon, LLC | 63459-912 | 63459-0912-1163459-0912-1563459-0912-17+1 more |
Other NDCs under BLA 125294
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 |
|---|---|---|---|---|
| Granixtbo-filgrastim | Filgrastim 300 ug/.5mL | Injection, SolutionSubcutaneous | Cephalon, LLC | 63459-910 |
| Granixtbo-filgrastim | Filgrastim 480 ug/.8mL | Injection, SolutionSubcutaneous | Cephalon, LLC | 63459-912 |
| Granixtbo-filgrastim | Filgrastim 300 ug/mL | Injection, SolutionSubcutaneous | Cephalon, LLC | 63459-918 |