NDC 63459-920

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 ID63459-920_520048a3-ead0-48c1-8435-f41860a5cde8
NDC63459-920
Product TypeHuman Prescription Drug
Proprietary NameGRANIX
Generic NameTbo-filgrastim
Dosage FormInjection, Solution
Route of AdministrationSUBCUTANEOUS
Marketing Start Date2018-11-07
Marketing CategoryBLA / BLA
Application NumberBLA125294
Labeler NameCephalon, Inc.
Substance NameFILGRASTIM
Active Ingredient Strength480 ug/1.6mL
Pharm ClassesGranulocyte Colony-Stimulating Factor [CS],Granulocyte-Macrophage Colony-Stimulating Factor [CS],Increased Myeloid Cell Production [PE],Leukocyte Growth Factor [EPC]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 63459-920-59

10 VIAL in 1 CARTON (63459-920-59) > 1.6 mL in 1 VIAL (63459-920-53)
Marketing Start Date2018-11-07
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 63459-920-59 [63459092059]

GRANIX INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA125294
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2018-11-07

NDC 63459-920-53 [63459092053]

GRANIX INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA125294
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2018-11-07

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"

NDCBrand NameGeneric Name
63459-910GRANIXtbo-filgrastim
63459-912GRANIXtbo-filgrastim
63459-918GRANIXtbo-filgrastim
63459-920GRANIXtbo-filgrastim

Trademark Results [GRANIX]

Mark Image

Registration | Serial
Company
Trademark
Application Date
GRANIX
GRANIX
85719440 4502497 Live/Registered
TEVA Pharmaceutical Industries Limited
2012-09-04
GRANIX
GRANIX
85280862 not registered Dead/Abandoned
TEVA Pharmaceutical Industries Ltd.
2011-03-30
GRANIX
GRANIX
77813830 3774550 Live/Registered
Asociacion Argentina de los Adventistasdel Septimo Dia - Alimentos Granix
2009-08-27
GRANIX
GRANIX
77813797 3774548 Live/Registered
Asociacion Argentina de los Adventistats del Septimo Dia-Alimentos Granix
2009-08-27
GRANIX
GRANIX
75500135 not registered Dead/Abandoned
Granix, Inc
1998-06-11
GRANIX
GRANIX
73743618 1546633 Live/Registered
ASOCIACION ARGENTINA DE LOS ADVENTISTASDEL SEPTIMO DIA-ALIMENTOS GRANIX
1988-08-01
GRANIX
GRANIX
73743421 1546632 Live/Registered
ASOCIACION ARGENTINA DE LOS ADVENTISTASDEL SEPTIMO DIA-ALIMENTOS GRANIX
1988-08-01

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