Active ingredient
Filgrastim
24 finished FDA listings contain Filgrastim as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- FILGRASTIM
- Dosage forms
- Injection, Injection, Solution
- Routes
- Intravenous, Subcutaneous
- Manufacturers / labelers
- 8
- Strengths listed
- 300 ug/.5ml · 300 ug/300ug · 300 ug/ml · 480 ug/.8ml · 480 ug/1.6ml · 480 ug/480ug
- Brand names in FDA listings
- Filkri, Granix, Neupogen, Nivestym, Nypozi, Nypozi Txid, Releuko, Zarxio
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 68442
Drugs@FDA applications
Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.
| Application | Sponsor | Original approval | Listings |
|---|---|---|---|
| BLA 103353 | AMGEN | 1991-02-20 | 4 |
| BLA 125294 | SICOR BIOTECH | 2012-08-29 | 4 |
| BLA 125553 | SANDOZ INC | 2015-03-06 | 2 |
| BLA 761080 | HOSPIRA INC | 2018-07-20 | 4 |
| BLA 761082 | KASHIV BIOSCIENCES LLC | 2022-02-25 | 4 |
| BLA 761126 | TANVEX BIOPHARMA USA INC | 2024-06-28 | 4 |
| BLA 761027 | ACCORD BIOPHARMA INC. | 2026-01-15 | 2 |
Official labeling on DailyMed
- NEUPOGEN (FILGRASTIM) INJECTION, SOLUTION [AMGEN, INC] · version 166 · 2026-07-29
- FILKRI (FILGRASTIM-LAHA) INJECTION, SOLUTION [ACCORD BIOPHARMA INC.,] · version 3 · 2026-07-17
- ZARXIO (FILGRASTIM-SNDZ) INJECTION, SOLUTION [SANDOZ INC.] · version 14 · 2026-06-15
- NYPOZI (FILGRASTIM-TXID) INJECTION [CIPLA USA INC.] · version 1 · 2026-02-16
- NYPOZI TXID (FILGRASTIM-TXID) INJECTION [TANVEX BIOPHARMA USA, INC.] · version 5 · 2026-01-21
- NIVESTYM (FILGRASTIM-AAFI) INJECTION, SOLUTION [PFIZER LABORATORIES DIV PFIZER INC] · version 18 · 2025-08-14
- RELEUKO (FILGRASTIM) INJECTION, SOLUTION [AMNEAL PHARMACEUTICALS LLC] · version 28 · 2025-05-15
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.