ZARXIO

Product NDC: 61314-312
Requested package NDC: 61314-312-01
11-digit product format: 613140312
Labeler code: 61314
Product ID: 61314-312_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: 480 ug/.8mL
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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	61314-312	61314-312-01	D	Discontinued by firm		2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
61314-312-01	ML - Milliliter	61314-312	d72f2e6b-01b2-4761-b318-912835f854a6	1	2015-10-02
61314-312-10	ML - Milliliter	61314-312	fc731446-cc6a-4292-bff6-c2faa7bff2b3	1	2015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
FILGRASTIM-SNDZ	ACTIVE INGREDIENT	PVI5M0M1GW	ZARXIO (FILGRASTIM-SNDZ) INJECTION, SOLUTION [SANDOZ INC]	13
FILGRASTIM-SNDZ	ACTIVE MOIETY	PVI5M0M1GW	ZARXIO (FILGRASTIM-SNDZ) INJECTION, SOLUTION [SANDOZ INC]	13
GLUTAMIC ACID	INACTIVE INGREDIENT	3KX376GY7L	ZARXIO (FILGRASTIM-SNDZ) INJECTION, SOLUTION [SANDOZ INC]	13
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	ZARXIO (FILGRASTIM-SNDZ) INJECTION, SOLUTION [SANDOZ INC]	13
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	ZARXIO (FILGRASTIM-SNDZ) INJECTION, SOLUTION [SANDOZ INC]	13
SORBITOL	INACTIVE INGREDIENT	506T60A25R	ZARXIO (FILGRASTIM-SNDZ) INJECTION, SOLUTION [SANDOZ INC]	13
WATER	INACTIVE INGREDIENT	059QF0KO0R	ZARXIO (FILGRASTIM-SNDZ) INJECTION, SOLUTION [SANDOZ INC]	13

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ZARXIO	FILGRASTIM-SNDZ	Sandoz Inc.	c0d1c22b-566b-4776-bdbf-00f96dad0cae	2025-08-29	Warnings, Adverse reactions	Exact identifier application number: BLA125553

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLA	Proprietary name	Proper name	License type	Status	Latest source
125553	Zarxio	filgrastim-sndz	351(k) Biosimilar	Rx	2026-08-01

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
PVI5M0M1GW	FILGRASTIM	121181-53-1	FILGRASTIM

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
61314-312-01	61314031201	1 BLISTER PACK in 1 CARTON (61314-312-01) > 1 SYRINGE in 1 BLISTER PACK > .8 mL in 1 SYRINGE	1 blister pack	2015-09-03	2021-02-28	No	No	Current