Granix
Tbo-filgrastim · Injection, Solution · Subcutaneous
No FDA structured label text is available for Granix. The NDC listings below come from the FDA National Drug Code directory.
Active ingredients
- Filgrastim in 4 products
Granix NDC products (4)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 63459-910 | Filgrastim 300 ug/.5mL Injection, Solution | Cephalon, LLC | BLA |
| 63459-912 | Filgrastim 480 ug/.8mL Injection, Solution | Cephalon, LLC | BLA |
| 63459-918 | Filgrastim 300 ug/mL Injection, Solution | Cephalon, LLC | BLA |
| 63459-920 | Filgrastim 480 ug/1.6mL Injection, Solution | Cephalon, LLC | BLA |
Granix recalls
- D-0218-2025 Feb 12, 2025 · Class II · Ongoing
Failed Stability Specifications - 12-month stability test result for one of the known peptides is below the specification limit
Frequently asked questions
Who makes Granix?
Granix is listed by 1 labeler in the FDA NDC directory, including Cephalon, LLC.
Has Granix been recalled?
The FDA enforcement database lists 1 recall for Granix, most recently D-0218-2025 (class ii): Failed Stability Specifications - 12-month stability test result for one of the known peptides is below the specification limit