NDC 63459-910

GRANIX

Tbo-filgrastim

GRANIX is a Subcutaneous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Cephalon, Inc.. The primary component is Filgrastim.

• Product ID: 63459-910_520048a3-ead0-48c1-8435-f41860a5cde8
• NDC: 63459-910
• Product Type: Human Prescription Drug
• Proprietary Name: GRANIX
• Generic Name: Tbo-filgrastim
• Dosage Form: Injection, Solution
• Route of Administration: SUBCUTANEOUS
• Marketing Start Date: 2013-11-11
• Marketing Category: BLA / BLA
• Application Number: BLA125294
• Labeler Name: Cephalon, Inc.
• Substance Name: FILGRASTIM
• Active Ingredient Strength: 300 ug/.5mL
• Pharm Classes: Granulocyte Colony-Stimulating Factor [CS],Granulocyte-Macrophage Colony-Stimulating Factor [CS],Increased Myeloid Cell Production [PE],Leukocyte Growth Factor [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 63459-910-11

1 BLISTER PACK in 1 CARTON (63459-910-11) > 1 SYRINGE, GLASS in 1 BLISTER PACK (63459-910-12) > .5 mL in 1 SYRINGE, GLASS (63459-910-01)

• Marketing Start Date: 2013-11-11
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 63459-910-11 [63459091011]

GRANIX INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA125294
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2013-11-11

NDC 63459-910-18 [63459091018]

GRANIX INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA125294
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2015-01-07

NDC 63459-910-15 [63459091015]

GRANIX INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA125294
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2013-11-11

NDC 63459-910-01 [63459091001]

GRANIX INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA125294
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2013-11-11

NDC 63459-910-17 [63459091017]

GRANIX INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA125294
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2015-03-02

NDC 63459-910-12 [63459091012]

GRANIX INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA125294
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2013-11-11

NDC 63459-910-36 [63459091036]

GRANIX INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA125294
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2015-03-02

Drug Details

Pharmacological Class

• Granulocyte Colony-Stimulating Factor [CS]
• Granulocyte-Macrophage Colony-Stimulating Factor [CS]
• Increased Myeloid Cell Production [PE]
• Leukocyte Growth Factor [EPC]

NDC Crossover Matching brand name "GRANIX" or generic name "Tbo-filgrastim"

NDC	Brand Name	Generic Name
63459-910	GRANIX	tbo-filgrastim
63459-912	GRANIX	tbo-filgrastim
63459-918	GRANIX	tbo-filgrastim
63459-920	GRANIX	tbo-filgrastim