FDA.reportPublic FDA data

GRANIX

Product NDC
63459-910
11-digit product format
634590910
Labeler code
63459
Product ID
63459-910_bebf458b-946a-4cc0-b565-5e2637f48cb2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
tbo-filgrastim
Dosage form
INJECTION, SOLUTION
Route
SUBCUTANEOUS
Labeler
Cephalon, LLC
Application
BLA125294
Marketing category
BLA
Marketing start
2013-11-11
Substance
FILGRASTIM
Active strength
300 ug/.5mL
Pharmacologic classes
Granulocyte Colony-Stimulating Factor [CS], Increased Myeloid Cell Production [PE], Leukocyte Growth Factor [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
GRANIX
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FILGRASTIM300 ug/.5mL

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
63459-910-01GRANIX0.5 mL in 1 SYRINGE, GLASSINJECTION, SOLUTION0.526
63459-910-11GRANIX1 in 1 CARTONINJECTION, SOLUTION126
63459-910-12GRANIX1 in 1 BLISTER PACKINJECTION, SOLUTION126
63459-910-15GRANIX10 in 1 CARTONINJECTION, SOLUTION1026
63459-910-17GRANIX1 in 1 CARTONINJECTION, SOLUTION126
63459-910-18GRANIX0.5 mL in 1 SYRINGE, GLASSINJECTION, SOLUTION0.526
63459-910-36GRANIX5 in 1 CARTONINJECTION, SOLUTION526

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63459-910-01ML - Milliliter63459-910d9bd06eb-7275-4a8f-b996-9cfab4e80a0612017-03-06
63459-910-11ML - Milliliter63459-91067b3f544-b5d4-40d0-9bd5-8b93946d482212014-01-04
63459-910-12ML - Milliliter63459-910d11ab1e3-7f69-4f25-b3d3-c364530c015412018-01-12
63459-910-15ML - Milliliter63459-910e0f382e4-c797-439b-bd8f-a2bdcae4051412014-01-04
63459-910-17ML - Milliliter63459-91068351ee1-0f01-4889-b068-a181224239a412015-03-03
63459-910-36ML - Milliliter63459-9107648e2a2-1f25-4115-9341-f78957ab0ccc12015-03-03

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
63459-910GRANIX (TBO-FILGRASTIM) INJECTION, SOLUTION [CEPHALON, LLC]22Current NDC, Legacy NDC, 7 package rows20231208_df918ec2-0907-443f-a52a-b72866959644.zip

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125294Granixtbo-filgrastim351(a)Rx2026-09-01

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
63459-910-01634590910010.5 mL in 1 SYRINGE, GLASS0.5 mlHistorical
63459-910-11634590910111 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) 1 blister pack2013-11-110000-00-00NoNoCurrent
63459-910-12634590910121 in 1 BLISTER PACKHistorical
63459-910-156345909101510 BLISTER PACK in 1 CARTON (63459-910-15) / 1 SYRINGE, GLASS in 1 BLISTER PACK (63459-910-12) / .5 mL in 1 SYRINGE, GLASS (63459-910-01) 10 blister pack2013-11-110000-00-00NoNoCurrent
63459-910-17634590910171 SYRINGE, GLASS in 1 CARTON (63459-910-17) / .5 mL in 1 SYRINGE, GLASS (63459-910-18) 2015-03-020000-00-00NoNoCurrent
63459-910-18634590910180.5 mL in 1 SYRINGE, GLASS0.5 mlHistorical
63459-910-36634590910365 SYRINGE, GLASS in 1 CARTON (63459-910-36) / .5 mL in 1 SYRINGE, GLASS (63459-910-18) 2015-03-020000-00-00NoNoCurrent