NDC 63459-910 – Granix
Filgrastim 300 ug/.5mL · Injection, Solution · Subcutaneous
Product NDC63459-910
Product details
- Brand name
- Granix
- Generic name
- Tbo-filgrastim
- Labeler
- Cephalon, LLC
- Dosage form
- Injection, Solution
- Route
- Subcutaneous
- Marketing category
- BLA · BLA125294
- Marketed since
- November 11, 2013
- Listing expires
- December 31, 2027
- Pharmacologic class
- Leukocyte Growth Factor
Active ingredients
- Filgrastim 300 ug/.5mL
Package NDC codes (4)
| Package NDC | Description | Since |
|---|---|---|
| 63459-910-11 | 1 BLISTER PACK in 1 CARTON (63459-910-11) / 1 SYRINGE, GLASS in 1 BLISTER PACK (63459-910-12) / .5 mL in 1 SYRINGE, GLASS (63459-910-01) | Nov 11, 2013 |
| 63459-910-15 | 10 BLISTER PACK in 1 CARTON (63459-910-15) / 1 SYRINGE, GLASS in 1 BLISTER PACK (63459-910-12) / .5 mL in 1 SYRINGE, GLASS (63459-910-01) | Nov 11, 2013 |
| 63459-910-17 | 1 SYRINGE, GLASS in 1 CARTON (63459-910-17) / .5 mL in 1 SYRINGE, GLASS (63459-910-18) | Mar 2, 2015 |
| 63459-910-36 | 5 SYRINGE, GLASS in 1 CARTON (63459-910-36) / .5 mL in 1 SYRINGE, GLASS (63459-910-18) | Mar 2, 2015 |
Recalls mentioning this NDC
- D-0218-2025 Feb 12, 2025 · Class II
Failed Stability Specifications - 12-month stability test result for one of the known peptides is below the specification limit