ZARXIO
- Product NDC
- 61314-318
- 11-digit product format
- 613140318
- Labeler code
- 61314
- Product ID
- 61314-318_5047f866-a689-466d-9808-52138bd638c4
- 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
- Substance
- FILGRASTIM
- Active strength
- 300 ug/.5mL
- Pharmacologic classes
- Granulocyte Colony-Stimulating Factor [CS], Increased Myeloid Cell Production [PE], Leukocyte Growth Factor [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- ZARXIO
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| FILGRASTIM | 300 ug/.5mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | PVI5M0M1GW |
| Rxcui | 1605066, 1605071, 1605074, 1605075 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 61314-318-01 | ZARXIO | 1 in 1 BLISTER PACK | INJECTION, SOLUTION | 1 | | 13 |
| 61314-318-01 | ZARXIO | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 13 |
| 61314-318-05 | ZARXIO | 5 in 1 BLISTER PACK | INJECTION, SOLUTION | 5 | | 13 |
| 61314-318-05 | ZARXIO | 0.5 mL in 1 SYRINGE | INJECTION, SOLUTION | 0.5 | | 13 |
| 61314-318-10 | ZARXIO | 2 in 1 CARTON | INJECTION, SOLUTION | 2 | | 13 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 61314-318 | ZARXIO (FILGRASTIM-SNDZ) INJECTION, SOLUTION [SANDOZ INC.] | 12 | Current NDC, Legacy NDC, 5 package rows | 20241103_c0d1c22b-566b-4776-bdbf-00f96dad0cae.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 61314-318-01 | 61314031801 | 1 BLISTER PACK in 1 CARTON (61314-318-01) / 1 SYRINGE in 1 BLISTER PACK / .5 mL in 1 SYRINGE | 1 blister pack | 2018-02-22 | 0000-00-00 | No | No | Current |
| 61314-318-05 | 61314031805 | 5 in 1 BLISTER PACK | | | | | | Historical |
| 61314-318-10 | 61314031810 | 2 BLISTER PACK in 1 CARTON (61314-318-10) / 5 SYRINGE in 1 BLISTER PACK (61314-318-05) / .5 mL in 1 SYRINGE | 2 blister pack | 2018-02-22 | 0000-00-00 | No | No | Current |