NDC Code(s) : 61314-318-01, 61314-318-05, 61314-318-10, 61314-326-01, 61314-326-05, 61314-326-10
Packager : Sandoz Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

ZARXIOfilgrastim-sndz INJECTION, SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:61314-318
Route of Administration INTRAVENOUS, SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FILGRASTIM(UNII: PVI5M0M1GW)
(FILGRASTIM - UNII:PVI5M0M1GW) 		FILGRASTIM300 ug in 0.5 mL
Inactive Ingredients
Ingredient Name Strength
GLUTAMIC ACID(UNII: 3KX376GY7L)0.736 mg in 0.5 mL
SORBITOL(UNII: 506T60A25R)25 mg in 0.5 mL
POLYSORBATE 80(UNII: 6OZP39ZG8H)0.02 mg in 0.5 mL
SODIUM HYDROXIDE(UNII: 55X04QC32I)
WATER(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:61314-318-011 in 1 CARTON 22/02/2018
11 in 1 BLISTER PACK
10.5 mL in 1 SYRINGE Type 3: Prefilled Biologic Delivery Device/System (syringe, patch, etc.)
2NDC:61314-318-102 in 1 CARTON 22/02/2018
2NDC:61314-318-055 in 1 BLISTER PACK
20.5 mL in 1 SYRINGE Type 3: Prefilled Biologic Delivery Device/System (syringe, patch, etc.)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125553 03/06/2015
ZARXIOfilgrastim-sndz INJECTION, SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:61314-326
Route of Administration INTRAVENOUS, SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FILGRASTIM(UNII: PVI5M0M1GW)
(FILGRASTIM - UNII:PVI5M0M1GW) 		FILGRASTIM480 ug in 0.8 mL
Inactive Ingredients
Ingredient Name Strength
GLUTAMIC ACID(UNII: 3KX376GY7L)1.178 mg in 0.8 mL
SORBITOL(UNII: 506T60A25R)40 mg in 0.8 mL
POLYSORBATE 80(UNII: 6OZP39ZG8H)0.032 mg in 0.8 mL
SODIUM HYDROXIDE(UNII: 55X04QC32I)
WATER(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:61314-326-011 in 1 CARTON 22/02/2018
11 in 1 BLISTER PACK
10.8 mL in 1 SYRINGE Type 3: Prefilled Biologic Delivery Device/System (syringe, patch, etc.)
2NDC:61314-326-102 in 1 CARTON 22/02/2018
2NDC:61314-326-055 in 1 BLISTER PACK
20.8 mL in 1 SYRINGE Type 3: Prefilled Biologic Delivery Device/System (syringe, patch, etc.)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125553 03/06/2015

LABELER - Sandoz Inc.(005387188)

PRINCIPAL DISPLAY PANEL

300mcg-label

Zarxio®

(filgrastim-sndz)

Injection

For Subcutaneous Use or

Intravenous Use Only

Single-Dose Only

1 prefilled syringe with a needle guard

300 mcg/0.5 mL

NDC 61314-318-01

A recombinant Granulocyte Colony-Stimulating Factor (rG-CSF)

derived from E Coli.

No Preservative.

Refrigerate. Protect from freezing.

Caution: Contains Natural Rubber Latex

Which May Cause Allergic Reaction.

Rx only

SANDOZ

A Novartis Division

PRINCIPAL DISPLAY PANEL

480mcg-label

Zarxio®

(filgrastim-sndz)

Injection

For Subcutaneous Use or

Intravenous Use Only

Single-Dose Only

1 prefilled syringe with a needle guard

480 mcg/0.8 mL

NDC 61314-326-01

A recombinant Granulocyte Colony-Stimulating Factor (rG-CSF)

derived from E Coli.

No Preservative.

Refrigerate. Protect from freezing.

Caution: Contains Natural Rubber Latex

Which May Cause Allergic Reaction.

Rx only

SANDOZ

A Novartis Division