NDC Code(s) : 63459-910-01, 63459-910-12, 63459-910-11, 63459-910-15, 63459-910-18, 63459-910-17, 63459-910-36, 63459-912-01, 63459-912-12, 63459-912-11, 63459-912-15, 63459-912-18, 63459-912-17, 63459-912-36, 63459-918-53, 63459-918-59, 63459-920-53, 63459-920-59
Packager : Cephalon, LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

GRANIXtbo-filgrastim INJECTION, SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63459-910
Route of Administration 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
ACETIC ACID(UNII: Q40Q9N063P)
SORBITOL(UNII: 506T60A25R)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
WATER(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:63459-910-111 in 1 CARTON 11/11/2013
1NDC:63459-910-121 in 1 BLISTER PACK
1NDC:63459-910-010.5 mL in 1 SYRINGE, GLASS Type 3: Prefilled Biologic Delivery Device/System (syringe, patch, etc.)
2NDC:63459-910-1510 in 1 CARTON 11/11/2013
2NDC:63459-910-121 in 1 BLISTER PACK
2NDC:63459-910-010.5 mL in 1 SYRINGE, GLASS Type 3: Prefilled Biologic Delivery Device/System (syringe, patch, etc.)
3NDC:63459-910-171 in 1 CARTON 03/02/2015
3NDC:63459-910-180.5 mL in 1 SYRINGE, GLASS Type 3: Prefilled Biologic Delivery Device/System (syringe, patch, etc.)
4NDC:63459-910-365 in 1 CARTON 03/02/2015
4NDC:63459-910-180.5 mL in 1 SYRINGE, GLASS 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 BLA125294 11/11/2013
GRANIXtbo-filgrastim INJECTION, SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63459-912
Route of Administration 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
ACETIC ACID(UNII: Q40Q9N063P)
SORBITOL(UNII: 506T60A25R)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
WATER(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:63459-912-111 in 1 CARTON 11/11/2013
1NDC:63459-912-121 in 1 BLISTER PACK
1NDC:63459-912-010.8 mL in 1 SYRINGE, GLASS Type 3: Prefilled Biologic Delivery Device/System (syringe, patch, etc.)
2NDC:63459-912-1510 in 1 CARTON 11/11/2013
2NDC:63459-912-121 in 1 BLISTER PACK
2NDC:63459-912-010.8 mL in 1 SYRINGE, GLASS Type 3: Prefilled Biologic Delivery Device/System (syringe, patch, etc.)
3NDC:63459-912-171 in 1 CARTON 03/02/2015
3NDC:63459-912-180.8 mL in 1 SYRINGE, GLASS Type 3: Prefilled Biologic Delivery Device/System (syringe, patch, etc.)
4NDC:63459-912-365 in 1 CARTON 03/02/2015
4NDC:63459-912-180.8 mL in 1 SYRINGE, GLASS 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 BLA125294 11/11/2013
GRANIXtbo-filgrastim INJECTION, SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63459-918
Route of Administration SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FILGRASTIM(UNII: PVI5M0M1GW)
(FILGRASTIM - UNII:PVI5M0M1GW) 		FILGRASTIM300 ug in 1 mL
Inactive Ingredients
Ingredient Name Strength
ACETIC ACID(UNII: Q40Q9N063P)
SORBITOL(UNII: 506T60A25R)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
WATER(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:63459-918-5910 in 1 CARTON 11/07/2018
1NDC:63459-918-531 mL in 1 VIAL Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125294 11/07/2018
GRANIXtbo-filgrastim INJECTION, SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63459-920
Route of Administration SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FILGRASTIM(UNII: PVI5M0M1GW)
(FILGRASTIM - UNII:PVI5M0M1GW) 		FILGRASTIM480 ug in 1.6 mL
Inactive Ingredients
Ingredient Name Strength
ACETIC ACID(UNII: Q40Q9N063P)
SORBITOL(UNII: 506T60A25R)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
WATER(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:63459-920-5910 in 1 CARTON 11/07/2018
1NDC:63459-920-531.6 mL in 1 VIAL Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125294 11/07/2018

LABELER - Cephalon, LLC(183236314)

PRINCIPAL DISPLAY PANEL

NDC 63459-910-11

Rx only

Granix® (tbo-filgrastim) Injection 

300 mcg/0.5 mL

For Subcutaneous Use Only

A recombinant Granulocyte Colony-Stimulating Factor (rG-CSF) derived from E Coli

300 mcg/0.5 mL

For Healthcare Professional Use Only

1 Single-dose prefilled syringe with a safety needle guard

Discard unused portion

1

PRINCIPAL DISPLAY PANEL

NDC 63459-910-17

Granix® (tbo-filgrastim) Injection

300 mcg/0.5 mL

For Subcutaneous Use Only

A recombinant Granulocyte Colony-Stimulating Factor (rG-CSF) derived from E Coli

1 Single-dose prefilled syringe WITHOUT a safety needle guard

Rx only

Discard unused portion

300 mcg/0.5 mL

1

PRINCIPAL DISPLAY PANEL

NDC 63459-912-11

Rx only

Granix® (tbo-filgrastim) Injection

480 mcg/0.8 mL

For Subcutaneous Use Only

A recombinant Granulocyte Colony-Stimulating Factor (rG-CSF) derived from E Coli

480 mcg/0.8 mL

For Healthcare Professional Use Only

1 Single-dose prefilled syringe with a safety needle guard

Discard unused portion

1

PRINCIPAL DISPLAY PANEL

NDC 63459-912-17

Rx only

Granix® (tbo-filgrastim) Injection

480 mcg/0.8 mL

For Subcutaneous Use Only

A recombinant Granulocyte Colony-Stimulating Factor (rG-CSF) derived from E Coli

480 mcg/0.8 mL

For Healthcare Professional Use Only

1 Single-dose prefilled syringe WITHOUT a safety needle guard

Discard unused portion

1

PRINCIPAL DISPLAY PANEL

NDC 63459-918-59

10 x 300 mcg/mL Single-Dose Vials (containing 1 mL)

Granix (tbo-filgrastim) Injection

300 mcg/mL

For Subcutaneous Use Only.

A recombinant Granulocyte Colony-Stimulating Factor (rG-CSF) derived from E. coli. Discard unused portion.

Rx Only

1

PRINCIPAL DISPLAY PANEL

NDC 63459-920-59

10 x 480 mcg/1.6 mL Single-Dose Vials

Granix (tbo-filgrastim) Injection 

480 mcg/1.6 mL

For Subcutaneous Use Only. A recombinant Granulocyte Colony-Stimulating Factor (rG-CSF) derived from E. coli. Discard unused portion.

Rx Only

1