FDA.reportPublic FDA data

RELEUKO

Product NDC
70121-1568
11-digit product format
701211568
Labeler code
70121
Product ID
70121-1568_7dd755fd-d4fe-431a-97a2-1ded5cf1a24b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Filgrastim
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS; SUBCUTANEOUS
Labeler
Amneal Pharmaceuticals LLC
Application
BLA761082
Marketing category
BLA
Marketing start
2022-02-25
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FILGRASTIM300 ug/.5mL

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
2595944Internal RxNorm lookup
2595950Internal RxNorm lookup
2595953Internal RxNorm lookup
2595957Internal RxNorm lookup
2595959Internal RxNorm lookup
2595960Internal RxNorm lookup
2595961Internal RxNorm lookup
2595962Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
74e1ec6e-1630-4654-895c-2bd355f939e7Available 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
70121-1568-1RELEUKO1 in 1 BOXINJECTION, SOLUTION128
70121-1568-1RELEUKO0.5 mL in 1 SYRINGEINJECTION, SOLUTION0.528
70121-1568-7RELEUKO10 in 1 BOXINJECTION, SOLUTION1028
70121-1568-7RELEUKO0.5 mL in 1 SYRINGEINJECTION, SOLUTION0.528

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70121-1568-1ML - Milliliter70121-15689dc96fd8-8cfd-44d7-af9d-a0e398dbbdb312022-04-06
70121-1568-7ML - Milliliter70121-1568389cecde-bca9-4029-978e-0a75d48643e312022-04-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70121-1568RELEUKO (FILGRASTIM) INJECTION, SOLUTION [AMNEAL PHARMACEUTICALS LLC]28Current NDC, Legacy NDC, 4 package rows20250515_74e1ec6e-1630-4654-895c-2bd355f939e7.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
RELEUKOFILGRASTIMAmneal Pharmaceuticals LLC74e1ec6e-1630-4654-895c-2bd355f939e72025-04-24Warnings, Adverse reactionsExact identifier
application number: BLA761082
ndc (product): 70121-1568

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761082Releukofilgrastim-ayow351(k) BiosimilarRx2026-08-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2595944filgrastim-ayow 300 MCG in 0.5 ML Prefilled SyringePSN74e1ec6e-1630-4654-895c-2bd355f939e728
2595953filgrastim-ayow 300 MCG in 1 ML InjectionPSN74e1ec6e-1630-4654-895c-2bd355f939e728
2595961filgrastim-ayow 480 MCG in 0.8 ML Prefilled SyringePSN74e1ec6e-1630-4654-895c-2bd355f939e728
2595959filgrastim-ayow 480 MCG in 1.6 ML InjectionPSN74e1ec6e-1630-4654-895c-2bd355f939e728
2595950Releuko 300 MCG in 0.5 ML Prefilled SyringePSN74e1ec6e-1630-4654-895c-2bd355f939e728
2595957Releuko 300 MCG in 1 ML InjectionPSN74e1ec6e-1630-4654-895c-2bd355f939e728
2595962Releuko 480 MCG in 0.8 ML Prefilled SyringePSN74e1ec6e-1630-4654-895c-2bd355f939e728
2595960Releuko 480 MCG in 1.6 ML InjectionPSN74e1ec6e-1630-4654-895c-2bd355f939e728
25959500.5 ML filgrastim-ayow 0.6 MG/ML Prefilled Syringe [Releuko]SBD74e1ec6e-1630-4654-895c-2bd355f939e728
25959620.8 ML filgrastim-ayow 0.6 MG/ML Prefilled Syringe [Releuko]SBD74e1ec6e-1630-4654-895c-2bd355f939e728
25959571 ML filgrastim-ayow 0.3 MG/ML Injection [Releuko]SBD74e1ec6e-1630-4654-895c-2bd355f939e728
25959601.6 ML filgrastim-ayow 0.3 MG/ML Injection [Releuko]SBD74e1ec6e-1630-4654-895c-2bd355f939e728
25959440.5 ML filgrastim-ayow 0.6 MG/ML Prefilled SyringeSCD74e1ec6e-1630-4654-895c-2bd355f939e728
25959610.8 ML filgrastim-ayow 0.6 MG/ML Prefilled SyringeSCD74e1ec6e-1630-4654-895c-2bd355f939e728
25959531 ML filgrastim-ayow 0.3 MG/ML InjectionSCD74e1ec6e-1630-4654-895c-2bd355f939e728
25959591.6 ML filgrastim-ayow 0.3 MG/ML InjectionSCD74e1ec6e-1630-4654-895c-2bd355f939e728
25959601.6 ML Releuko 0.3 MG/ML InjectionSY74e1ec6e-1630-4654-895c-2bd355f939e728
2595953filgrastim-ayow 0.3 MG/ML per 1 ML InjectionSY74e1ec6e-1630-4654-895c-2bd355f939e728
2595944filgrastim-ayow 0.6 MG/ML per 0.5 ML Prefilled SyringeSY74e1ec6e-1630-4654-895c-2bd355f939e728
2595961filgrastim-ayow 0.6 MG/ML per 0.8 ML Prefilled SyringeSY74e1ec6e-1630-4654-895c-2bd355f939e728
2595944filgrastim-ayow 300 MCG per 0.5 ML Prefilled SyringeSY74e1ec6e-1630-4654-895c-2bd355f939e728
2595953filgrastim-ayow 300 MCG per 1 ML InjectionSY74e1ec6e-1630-4654-895c-2bd355f939e728
2595961filgrastim-ayow 480 MCG per 0.8 ML Prefilled SyringeSY74e1ec6e-1630-4654-895c-2bd355f939e728
2595959filgrastim-ayow 480 MCG per 1.6 ML InjectionSY74e1ec6e-1630-4654-895c-2bd355f939e728
2595957Releuko 0.3 MG/ML per 1 ML InjectionSY74e1ec6e-1630-4654-895c-2bd355f939e728
2595950Releuko 0.6 MG/ML per 0.5 ML Prefilled SyringeSY74e1ec6e-1630-4654-895c-2bd355f939e728
2595962Releuko 0.6 MG/ML per 0.8 ML Prefilled SyringeSY74e1ec6e-1630-4654-895c-2bd355f939e728
2595950Releuko 300 MCG per 0.5 ML Prefilled SyringeSY74e1ec6e-1630-4654-895c-2bd355f939e728
2595957Releuko 300 MCG per 1 ML InjectionSY74e1ec6e-1630-4654-895c-2bd355f939e728
2595962Releuko 480 MCG per 0.8 ML Prefilled SyringeSY74e1ec6e-1630-4654-895c-2bd355f939e728
2595960Releuko 480 MCG per 1.6 ML InjectionSY74e1ec6e-1630-4654-895c-2bd355f939e728

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70121-1568-1701211568011 SYRINGE in 1 BOX (70121-1568-1) / .5 mL in 1 SYRINGE1 syringe2022-02-250000-00-00NoNoCurrent
70121-1568-77012115680710 SYRINGE in 1 BOX (70121-1568-7) / .5 mL in 1 SYRINGE10 syringe2022-02-250000-00-00NoNoCurrent