ZARXIO
- Product NDC
- 61314-304
- 11-digit product format
- 613140304
- Labeler code
- 61314
- Product ID
- 61314-304_29b8c07f-2722-49d2-813c-cd19dbe57fbe
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- filgrastim-sndz
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS; SUBCUTANEOUS
- Labeler
- Sandoz Inc.
- Application
- BLA125553
- Marketing category
- BLA
- Marketing start
- 2015-03-06
- Marketing end
- 2021-02-28
- Substance
- FILGRASTIM
- Active strength
- 300 ug/.5mL
- Pharmacologic classes
- Granulocyte Colony-Stimulating Factor [CS],Granulocyte-Macrophage Colony-Stimulating Factor [CS],Increased Myeloid Cell Production [PE],Leukocyte Growth Factor [EPC]
- NDC exclude flag
- No
- Listing certified through
- 0000-00-00
- Current FDA listing
- Historical FDA.report record
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 61314-304-01 | 61314030401 | 1 BLISTER PACK in 1 CARTON (61314-304-01) > 1 SYRINGE in 1 BLISTER PACK > .5 mL in 1 SYRINGE | 1 blister pack | 2015-09-03 | 2021-02-28 | No | No | Current |
| 61314-304-10 | 61314030410 | 2 BLISTER PACK in 1 CARTON (61314-304-10) > 5 SYRINGE in 1 BLISTER PACK > .5 mL in 1 SYRINGE | 2 blister pack | 2015-09-03 | 2021-02-28 | No | No | Current |