Drug Information

Product NDC: 61314-304

Proprietary Name: ZARXIO

Non Proprietary Name: filgrastim-sndz

Active Ingredient(s):

Administration Route(s): INTRAVENOUS; SUBCUTANEOUS


Pharmacy Class(es):
  • Granulocyte Colony-Stimulating Factor [CS];
  • Granulocyte-Macrophage Colony-Stimulating Factor [CS];
  • Increased Myeloid Cell Production [PE];
  • Leukocyte Growth Factor [EPC]

Labeler Information

Labeler Name: Sandoz Inc
FDA Application Number: BLA125553
Marketing Category: BLA
Start Marketing Date:3/6/2015

Package Information

No. Package Code Package Description Billing Unit
161314-304-011 BLISTER PACK in 1 CARTON (61314-304-01) > 1 SYRINGE in 1 BLISTER PACK > .5 mL in 1 SYRINGEML
261314-304-102 BLISTER PACK in 1 CARTON (61314-304-10) > 5 SYRINGE in 1 BLISTER PACK > .5 mL in 1 SYRINGEML

NDC Record

Field Name Field Value Definition
PRODUCT NDC61314-304The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
PRODUCT TYPE NAMEHUMAN PRESCRIPTION DRUGIndicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
PROPRIETARY NAMEZARXIOThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMEfilgrastim-sndzThe non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMEINJECTION, SOLUTIONThe translation of the dosage form Code submitted by the firm.
ROUTE NAMEINTRAVENOUS; SUBCUTANEOUSThe translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE3/6/2015This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMEBLAProduct types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
APPLICATION NUMBERBLA125553This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
LABELER NAMESandoz IncName of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMEFILGRASTIM, LICENSE HOLDER UNSPECIFIEDThis is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
PHARM CLASSESGranulocyte Colony-Stimulating Factor [CS],Granulocyte-Macrophage Colony-Stimulating Factor [CS],Increased Myeloid Cell Production [PE],Leukocyte Growth Factor [EPC] 

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This page was last updated on: 11/18/2019