FDA.reportPublic FDA data

RELEUKO

Product NDC
70121-1571
11-digit product format
701211571
Labeler code
70121
Product ID
70121-1571_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
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
RELEUKO
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FILGRASTIM480 ug/1.6mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiPVI5M0M1GW
Rxcui2595944, 2595950, 2595953, 2595957, 2595959, 2595960, 2595961, 2595962

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
70121-1571-7RELEUKO1.6 mL in 1 VIALINJECTION, SOLUTION1.628
70121-1571-7RELEUKO10 in 1 PACKAGEINJECTION, SOLUTION1028

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70121-1571-1ML - Milliliter70121-157189295cc6-1a22-4781-99e6-a09acf6f091312022-04-06
70121-1571-7ML - Milliliter70121-1571b82a1bef-0c7c-42d9-bd96-d69c2002e36512022-04-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70121-1571RELEUKO (FILGRASTIM) INJECTION, SOLUTION [AMNEAL PHARMACEUTICALS LLC]28Current NDC, Legacy NDC, 2 package rows20250515_74e1ec6e-1630-4654-895c-2bd355f939e7.zip

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
70121-1571-77012115710710 VIAL in 1 PACKAGE (70121-1571-7) / 1.6 mL in 1 VIAL10 vial2022-02-250000-00-00NoNoCurrent