zarxio

Generic: filgrastim-sndz

Labeler: sandoz inc.
NDC Directory HUMAN PRESCRIPTION DRUG BLA Inactive Finished

Drug Facts

Product Profile

Brand Name zarxio
Generic Name filgrastim-sndz
Labeler sandoz inc.
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS SUBCUTANEOUS
Active Ingredients

filgrastim 300 ug/.5mL

Manufacturer
Sandoz Inc.

Identifiers & Regulatory

Product NDC 61314-318
Product ID 61314-318_5047f866-a689-466d-9808-52138bd638c4
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA125553
Listing Expiration 2026-12-31
Marketing Start 2015-03-06

Pharmacologic Class

Established (EPC)
leukocyte growth factor [epc]
Chemical Structure
granulocyte colony-stimulating factor [cs]
Physiologic Effect
increased myeloid cell production [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 61314318
Hyphenated Format 61314-318

Supplemental Identifiers

RxCUI
1605066 1605071 1605074 1605075
UNII
PVI5M0M1GW
NUI
M0024696 N0000009451 N0000175666

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name zarxio (source: ndc)
Generic Name filgrastim-sndz (source: ndc)
Application Number BLA125553 (source: ndc)
Routes
INTRAVENOUS SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 300 ug/.5mL
source: ndc
Packaging
  • 1 BLISTER PACK in 1 CARTON (61314-318-01) / 1 SYRINGE in 1 BLISTER PACK / .5 mL in 1 SYRINGE
  • 2 BLISTER PACK in 1 CARTON (61314-318-10) / 5 SYRINGE in 1 BLISTER PACK (61314-318-05) / .5 mL in 1 SYRINGE
source: ndc

Packages (2)

61314-318-01 1 BLISTER PACK in 1 CARTON (61314-318-01) / 1 SYRINGE in 1 BLISTER PACK / .5 mL in 1 SYRINGE 61314-318-10 2 BLISTER PACK in 1 CARTON (61314-318-10) / 5 SYRINGE in 1 BLISTER PACK (61314-318-05) / .5 mL in 1 SYRINGE

Ingredients (1)

filgrastim (300 ug/.5mL)

Linked Drug Pages (1)

ZARXIO ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS", "SUBCUTANEOUS"], "spl_id": "5047f866-a689-466d-9808-52138bd638c4", "openfda": {"nui": ["M0024696", "N0000009451", "N0000175666"], "unii": ["PVI5M0M1GW"], "rxcui": ["1605066", "1605071", "1605074", "1605075"], "spl_set_id": ["c0d1c22b-566b-4776-bdbf-00f96dad0cae"], "pharm_class_cs": ["Granulocyte Colony-Stimulating Factor [CS]"], "pharm_class_pe": ["Increased Myeloid Cell Production [PE]"], "pharm_class_epc": ["Leukocyte Growth Factor [EPC]"], "manufacturer_name": ["Sandoz Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BLISTER PACK in 1 CARTON (61314-318-01)  / 1 SYRINGE in 1 BLISTER PACK / .5 mL in 1 SYRINGE", "package_ndc": "61314-318-01", "marketing_start_date": "20180222"}, {"sample": false, "description": "2 BLISTER PACK in 1 CARTON (61314-318-10)  / 5 SYRINGE in 1 BLISTER PACK (61314-318-05)  / .5 mL in 1 SYRINGE", "package_ndc": "61314-318-10", "marketing_start_date": "20180222"}], "brand_name": "ZARXIO", "product_id": "61314-318_5047f866-a689-466d-9808-52138bd638c4", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Granulocyte Colony-Stimulating Factor [CS]", "Increased Myeloid Cell Production [PE]", "Leukocyte Growth Factor [EPC]"], "product_ndc": "61314-318", "generic_name": "filgrastim-sndz", "labeler_name": "Sandoz Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ZARXIO", "active_ingredients": [{"name": "FILGRASTIM", "strength": "300 ug/.5mL"}], "application_number": "BLA125553", "marketing_category": "BLA", "marketing_start_date": "20150306", "listing_expiration_date": "20261231"}