FDA.reportPublic FDA data

GRANIX

Product NDC
63459-918
11-digit product format
634590918
Labeler code
63459
Product ID
63459-918_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
300 ug/mL
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
FILGRASTIM300 ug/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
PVI5M0M1GWInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 8 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1433768Internal RxNorm lookup
1433771Internal RxNorm lookup
1442681Internal RxNorm lookup
1442683Internal RxNorm lookup
2101456Internal RxNorm lookup
2101459Internal RxNorm lookup
2101464Internal RxNorm lookup
2101465Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
df918ec2-0907-443f-a52a-b72866959644Available on FDA.report

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
63459-918-53GRANIX1 mL in 1 VIALINJECTION, SOLUTION126
63459-918-59GRANIX10 in 1 CARTONINJECTION, SOLUTION1026

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63459-918-53ML - Milliliter63459-9189a757c41-130a-4b57-addf-702b7c4a2b6012018-12-13
63459-918-59ML - Milliliter63459-9181634c948-9ec5-4143-8890-7b056913987d12018-12-13

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
63459-918GRANIX (TBO-FILGRASTIM) INJECTION, SOLUTION [CEPHALON, LLC]22Current NDC, Legacy NDC, 2 package rows20231208_df918ec2-0907-443f-a52a-b72866959644.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GRANIXTBO-FILGRASTIMCephalon, LLCdf918ec2-0907-443f-a52a-b728669596442023-11-30Warnings, Adverse reactionsExact identifier
application number: BLA125294
ndc (product): 63459-918

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125294Granixtbo-filgrastim351(a)Rx2026-08-01

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
63459-918-53634590918531 mL in 1 VIAL1 mlHistorical
63459-918-596345909185910 VIAL in 1 CARTON (63459-918-59) / 1 mL in 1 VIAL (63459-918-53) 10 vial2018-11-070000-00-00NoNoCurrent