FDA.reportPublic FDA data

GRANIX

Product NDC
63459-920
11-digit product format
634590920
Labeler code
63459
Product ID
63459-920_063f36a7-6f99-40fa-af02-8a5183c51e99
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
tbo-filgrastim
Dosage form
INJECTION, SOLUTION
Route
SUBCUTANEOUS
Labeler
Cephalon, LLC
Application
BLA125294
Marketing category
BLA
Marketing start
2018-11-07
Substance
FILGRASTIM
Active strength
480 ug/1.6mL
Pharmacologic classes
Granulocyte Colony-Stimulating Factor [CS], Increased Myeloid Cell Production [PE], Leukocyte Growth Factor [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
GRANIX
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FILGRASTIM480 ug/1.6mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiPVI5M0M1GW
Rxcui1433768, 1433771, 1442681, 1442683, 2101456, 2101459, 2101464, 2101465

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0f366651-2cb6-4932-a760-2ae84fd8fbffProduct name120230703
3b1c6100-f679-4300-94a6-3b3fc05b0c44Product name120230110
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63459-920-53GRANIX1.6 mL in 1 VIALINJECTION, SOLUTION1.626
63459-920-59GRANIX10 in 1 CARTONINJECTION, SOLUTION1026

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63459-920-53ML - Milliliter63459-920dd698725-4fc8-4417-a676-5804bb9cc15612018-12-13
63459-920-59ML - Milliliter63459-920d3d09eba-bcaa-4ae8-96ae-2948d4b7575012018-12-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FILGRASTIMACTIVE INGREDIENTPVI5M0M1GWGRANIX (TBO-FILGRASTIM) INJECTION, SOLUTION [CEPHALON, INC.]4
FILGRASTIMACTIVE MOIETYPVI5M0M1GWGRANIX (TBO-FILGRASTIM) INJECTION, SOLUTION [CEPHALON, INC.]4
ACETIC ACIDINACTIVE INGREDIENTQ40Q9N063PGRANIX (TBO-FILGRASTIM) INJECTION, SOLUTION [CEPHALON, INC.]4
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HGRANIX (TBO-FILGRASTIM) INJECTION, SOLUTION [CEPHALON, INC.]4
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IGRANIX (TBO-FILGRASTIM) INJECTION, SOLUTION [CEPHALON, INC.]4
SORBITOLINACTIVE INGREDIENT506T60A25RGRANIX (TBO-FILGRASTIM) INJECTION, SOLUTION [CEPHALON, INC.]4
WATERINACTIVE INGREDIENT059QF0KO0RGRANIX (TBO-FILGRASTIM) INJECTION, SOLUTION [CEPHALON, INC.]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63459-920GRANIX (TBO-FILGRASTIM) INJECTION, SOLUTION [CEPHALON, LLC]22Current NDC, Legacy NDC, 2 package rows20231208_df918ec2-0907-443f-a52a-b72866959644.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1442681Granix 300 MCG in 0.5 ML Prefilled SyringePSNdf918ec2-0907-443f-a52a-b7286695964426
2101459Granix 300 MCG in 1 ML InjectionPSNdf918ec2-0907-443f-a52a-b7286695964426
1442683Granix 480 MCG in 0.8 ML Prefilled SyringePSNdf918ec2-0907-443f-a52a-b7286695964426
2101465Granix 480 MCG in 1.6 ML InjectionPSNdf918ec2-0907-443f-a52a-b7286695964426
1433768tbo-filgrastim 300 MCG in 0.5 ML Prefilled SyringePSNdf918ec2-0907-443f-a52a-b7286695964426
2101456tbo-filgrastim 300 MCG in 1 mL InjectionPSNdf918ec2-0907-443f-a52a-b7286695964426
1433771tbo-filgrastim 480 MCG in 0.8 ML Prefilled SyringePSNdf918ec2-0907-443f-a52a-b7286695964426
2101464tbo-filgrastim 480 MCG in 1.6 mL InjectionPSNdf918ec2-0907-443f-a52a-b7286695964426
14426810.5 ML tbo-filgrastim 0.6 MG/ML Prefilled Syringe [Granix]SBDdf918ec2-0907-443f-a52a-b7286695964426
14426830.8 ML tbo-filgrastim 0.6 MG/ML Prefilled Syringe [Granix]SBDdf918ec2-0907-443f-a52a-b7286695964426
21014591 ML tbo-filgrastim 0.3 MG/ML Injection [Granix]SBDdf918ec2-0907-443f-a52a-b7286695964426
21014651.6 ML tbo-filgrastim 0.3 MG/ML Injection [Granix]SBDdf918ec2-0907-443f-a52a-b7286695964426
14337680.5 ML tbo-filgrastim 0.6 MG/ML Prefilled SyringeSCDdf918ec2-0907-443f-a52a-b7286695964426
14337710.8 ML tbo-filgrastim 0.6 MG/ML Prefilled SyringeSCDdf918ec2-0907-443f-a52a-b7286695964426
21014561 ML tbo-filgrastim 0.3 MG/ML InjectionSCDdf918ec2-0907-443f-a52a-b7286695964426
21014641.6 ML tbo-filgrastim 0.3 MG/ML InjectionSCDdf918ec2-0907-443f-a52a-b7286695964426
14426810.5 ML Granix 0.6 MG/ML Prefilled SyringeSYdf918ec2-0907-443f-a52a-b7286695964426
14426830.8 ML Granix 0.6 MG/ML Prefilled SyringeSYdf918ec2-0907-443f-a52a-b7286695964426
2101459Granix 0.3 MG/ML per 1 ML InjectionSYdf918ec2-0907-443f-a52a-b7286695964426
2101465Granix 0.3 MG/ML per 1.6 ML InjectionSYdf918ec2-0907-443f-a52a-b7286695964426
1442681Granix 300 MCG per 0.5 ML Prefilled SyringeSYdf918ec2-0907-443f-a52a-b7286695964426
2101459Granix 300 MCG per 1 ML InjectionSYdf918ec2-0907-443f-a52a-b7286695964426
1442683Granix 480 MCG per 0.8 ML Prefilled SyringeSYdf918ec2-0907-443f-a52a-b7286695964426
2101465Granix 480 MCG per 1.6 ML InjectionSYdf918ec2-0907-443f-a52a-b7286695964426
2101456tbo-filgrastim 0.3 MG/ML per 1 ML InjectionSYdf918ec2-0907-443f-a52a-b7286695964426
2101464tbo-filgrastim 0.3 MG/ML per 1.6 ML InjectionSYdf918ec2-0907-443f-a52a-b7286695964426
1433768tbo-filgrastim 300 MCG per 0.5 ML Prefilled SyringeSYdf918ec2-0907-443f-a52a-b7286695964426
2101456tbo-filgrastim 300 MCG per 1 ML InjectionSYdf918ec2-0907-443f-a52a-b7286695964426
1433771tbo-filgrastim 480 MCG per 0.8 ML Prefilled SyringeSYdf918ec2-0907-443f-a52a-b7286695964426
2101464tbo-filgrastim 480 MCG per 1.6 ML InjectionSYdf918ec2-0907-443f-a52a-b7286695964426

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63459-920-53634590920531.6 mL in 1 VIAL1.6 mlHistorical
63459-920-596345909205910 VIAL in 1 CARTON (63459-920-59) / 1.6 mL in 1 VIAL (63459-920-53) 10 vial2018-11-072026-09-30NoNoCurrent