FDA.reportPublic FDA data

NEUPOGEN

Product NDC
55513-924
11-digit product format
555130924
Labeler code
55513
Product ID
55513-924_52115df1-de31-4353-a33b-5ca065af4e85
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Filgrastim
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS; SUBCUTANEOUS
Labeler
Amgen, Inc
Application
BLA103353
Marketing category
BLA
Marketing start
2000-10-02
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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FILGRASTIM300 ug/.5mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiPVI5M0M1GW
Rxcui727535, 727537, 727544, 727545, 1649944, 1649946, 1649963, 1649964

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
55513-924-01NEUPOGEN0.5 mL in 1 SYRINGEINJECTION, SOLUTION0.5164
55513-924-10NEUPOGEN10 in 1 BOXINJECTION, SOLUTION10164
55513-924-20NEUPOGEN10 in 1 BOXINJECTION, SOLUTION10164
55513-924-91NEUPOGEN1 in 1 BOXINJECTION, SOLUTION1164
55513-924-91NEUPOGEN0.5 mL in 1 SYRINGEINJECTION, SOLUTION0.5164

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55513-924-01ML - Milliliter55513-924c9c288d1-e31f-45a9-85ce-5569fbbefdd712012-07-24
55513-924-10ML - Milliliter55513-924700e725f-c00e-4e16-8414-3f59b856929d12012-07-24
55513-924-91ML - Milliliter55513-924bb4f96fd-54bc-408b-85e1-25ae491d36fb12014-05-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FILGRASTIM, LICENSE HOLDER UNSPECIFIEDACTIVE INGREDIENTPVI5M0M1GWNEUPOGEN (FILGRASTIM) INJECTION, SOLUTION [AMGEN INC]144
FILGRASTIM, LICENSE HOLDER UNSPECIFIEDACTIVE MOIETYPVI5M0M1GWNEUPOGEN (FILGRASTIM) INJECTION, SOLUTION [AMGEN INC]144
ACETIC ACIDINACTIVE INGREDIENTQ40Q9N063PNEUPOGEN (FILGRASTIM) INJECTION, SOLUTION [AMGEN INC]144
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HNEUPOGEN (FILGRASTIM) INJECTION, SOLUTION [AMGEN INC]144
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32INEUPOGEN (FILGRASTIM) INJECTION, SOLUTION [AMGEN INC]144
SORBITOLINACTIVE INGREDIENT506T60A25RNEUPOGEN (FILGRASTIM) INJECTION, SOLUTION [AMGEN INC]144
WATERINACTIVE INGREDIENT059QF0KO0RNEUPOGEN (FILGRASTIM) INJECTION, SOLUTION [AMGEN INC]144
FILGRASTIMACTIVE INGREDIENTPVI5M0M1GWNEUPOGEN (FILGRASTIM) INJECTION, SOLUTION [PHYSICIANS TOTAL CARE, INC.]1
FILGRASTIMACTIVE MOIETYPVI5M0M1GWNEUPOGEN (FILGRASTIM) INJECTION, SOLUTION [PHYSICIANS TOTAL CARE, INC.]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HNEUPOGEN (FILGRASTIM) INJECTION, SOLUTION [PHYSICIANS TOTAL CARE, INC.]1
SODIUM POLYMETAPHOSPHATEINACTIVE INGREDIENTP1BM4ZH95LNEUPOGEN (FILGRASTIM) INJECTION, SOLUTION [PHYSICIANS TOTAL CARE, INC.]1
SORBITOLINACTIVE INGREDIENT506T60A25RNEUPOGEN (FILGRASTIM) INJECTION, SOLUTION [PHYSICIANS TOTAL CARE, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RNEUPOGEN (FILGRASTIM) INJECTION, SOLUTION [PHYSICIANS TOTAL CARE, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55513-924NEUPOGEN (FILGRASTIM) INJECTION, SOLUTION [AMGEN, INC]162Current NDC, Legacy NDC, 5 package rows20250503_97cc73cc-b5b7-458a-a933-77b00523e193.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
727535filgrastim 300 MCG in 0.5 ML Prefilled SyringePSN97cc73cc-b5b7-458a-a933-77b00523e193164
1649944filgrastim 300 MCG in 1 ML InjectionPSN97cc73cc-b5b7-458a-a933-77b00523e193164
727544filgrastim 480 MCG in 0.8 ML Prefilled SyringePSN97cc73cc-b5b7-458a-a933-77b00523e193164
1649963filgrastim 480 MCG in 1.6 ML InjectionPSN97cc73cc-b5b7-458a-a933-77b00523e193164
727537Neupogen 300 MCG in 0.5 ML Prefilled SyringePSN97cc73cc-b5b7-458a-a933-77b00523e193164
1649946Neupogen 300 MCG in 1 ML InjectionPSN97cc73cc-b5b7-458a-a933-77b00523e193164
727545Neupogen 480 MCG in 0.8 ML Prefilled SyringePSN97cc73cc-b5b7-458a-a933-77b00523e193164
1649964Neupogen 480 MCG in 1.6 ML InjectionPSN97cc73cc-b5b7-458a-a933-77b00523e193164
7275370.5 ML filgrastim 0.6 MG/ML Prefilled Syringe [Neupogen]SBD97cc73cc-b5b7-458a-a933-77b00523e193164
7275450.8 ML filgrastim 0.6 MG/ML Prefilled Syringe [Neupogen]SBD97cc73cc-b5b7-458a-a933-77b00523e193164
16499461 ML filgrastim 0.3 MG/ML Injection [Neupogen]SBD97cc73cc-b5b7-458a-a933-77b00523e193164
16499641.6 ML filgrastim 0.3 MG/ML Injection [Neupogen]SBD97cc73cc-b5b7-458a-a933-77b00523e193164
7275350.5 ML filgrastim 0.6 MG/ML Prefilled SyringeSCD97cc73cc-b5b7-458a-a933-77b00523e193164
7275440.8 ML filgrastim 0.6 MG/ML Prefilled SyringeSCD97cc73cc-b5b7-458a-a933-77b00523e193164
16499441 ML filgrastim 0.3 MG/ML InjectionSCD97cc73cc-b5b7-458a-a933-77b00523e193164
16499631.6 ML filgrastim 0.3 MG/ML InjectionSCD97cc73cc-b5b7-458a-a933-77b00523e193164
7275370.5 ML Neupogen 0.6 MG/ML Prefilled SyringeSY97cc73cc-b5b7-458a-a933-77b00523e193164
7275450.8 ML Neupogen 0.6 MG/ML Prefilled SyringeSY97cc73cc-b5b7-458a-a933-77b00523e193164
16499461 ML Neupogen 0.3 MG/ML InjectionSY97cc73cc-b5b7-458a-a933-77b00523e193164
16499641.6 ML Neupogen 0.3 MG/ML InjectionSY97cc73cc-b5b7-458a-a933-77b00523e193164
727535filgrastim 0.3 MG per 0.5 ML Prefilled SyringeSY97cc73cc-b5b7-458a-a933-77b00523e193164
727544filgrastim 0.48 MG per 0.8 ML Prefilled SyringeSY97cc73cc-b5b7-458a-a933-77b00523e193164
727535filgrastim 300 MCG per 0.5 ML Prefilled SyringeSY97cc73cc-b5b7-458a-a933-77b00523e193164
1649944filgrastim 300 MCG per 1 ML InjectionSY97cc73cc-b5b7-458a-a933-77b00523e193164
727544filgrastim 480 MCG per 0.8 ML Prefilled SyringeSY97cc73cc-b5b7-458a-a933-77b00523e193164
1649963filgrastim 480 MCG per 1.6 ML InjectionSY97cc73cc-b5b7-458a-a933-77b00523e193164
727537Neupogen 300 MCG per 0.5 ML Prefilled SyringeSY97cc73cc-b5b7-458a-a933-77b00523e193164
1649946Neupogen 300 MCG per 1 ML InjectionSY97cc73cc-b5b7-458a-a933-77b00523e193164
727545Neupogen 480 MCG per 0.8 ML Prefilled SyringeSY97cc73cc-b5b7-458a-a933-77b00523e193164
1649964Neupogen 480 MCG per 1.6 ML InjectionSY97cc73cc-b5b7-458a-a933-77b00523e193164
727535filgrastim 300 MCG in 0.5 ML Prefilled SyringePSN3bc802bd-76b4-4f45-8571-a436ec26228e1
1649944filgrastim 300 MCG in 1 ML InjectionPSN3bc802bd-76b4-4f45-8571-a436ec26228e1
727544filgrastim 480 MCG in 0.8 ML Prefilled SyringePSN3bc802bd-76b4-4f45-8571-a436ec26228e1
727537Neupogen 300 MCG in 0.5 ML Prefilled SyringePSN3bc802bd-76b4-4f45-8571-a436ec26228e1
1649946Neupogen 300 MCG in 1 ML InjectionPSN3bc802bd-76b4-4f45-8571-a436ec26228e1
727545Neupogen 480 MCG in 0.8 ML Prefilled SyringePSN3bc802bd-76b4-4f45-8571-a436ec26228e1
7275370.5 ML filgrastim 0.6 MG/ML Prefilled Syringe [Neupogen]SBD3bc802bd-76b4-4f45-8571-a436ec26228e1
7275450.8 ML filgrastim 0.6 MG/ML Prefilled Syringe [Neupogen]SBD3bc802bd-76b4-4f45-8571-a436ec26228e1
16499461 ML filgrastim 0.3 MG/ML Injection [Neupogen]SBD3bc802bd-76b4-4f45-8571-a436ec26228e1
7275350.5 ML filgrastim 0.6 MG/ML Prefilled SyringeSCD3bc802bd-76b4-4f45-8571-a436ec26228e1
7275440.8 ML filgrastim 0.6 MG/ML Prefilled SyringeSCD3bc802bd-76b4-4f45-8571-a436ec26228e1
16499441 ML filgrastim 0.3 MG/ML InjectionSCD3bc802bd-76b4-4f45-8571-a436ec26228e1
7275370.5 ML Neupogen 0.6 MG/ML Prefilled SyringeSY3bc802bd-76b4-4f45-8571-a436ec26228e1
7275450.8 ML Neupogen 0.6 MG/ML Prefilled SyringeSY3bc802bd-76b4-4f45-8571-a436ec26228e1
16499461 ML Neupogen 0.3 MG/ML InjectionSY3bc802bd-76b4-4f45-8571-a436ec26228e1
727535filgrastim 0.3 MG per 0.5 ML Prefilled SyringeSY3bc802bd-76b4-4f45-8571-a436ec26228e1
727544filgrastim 0.48 MG per 0.8 ML Prefilled SyringeSY3bc802bd-76b4-4f45-8571-a436ec26228e1
727535filgrastim 300 MCG per 0.5 ML Prefilled SyringeSY3bc802bd-76b4-4f45-8571-a436ec26228e1
1649944filgrastim 300 MCG per 1 ML InjectionSY3bc802bd-76b4-4f45-8571-a436ec26228e1
727544filgrastim 480 MCG per 0.8 ML Prefilled SyringeSY3bc802bd-76b4-4f45-8571-a436ec26228e1
727537Neupogen 300 MCG per 0.5 ML Prefilled SyringeSY3bc802bd-76b4-4f45-8571-a436ec26228e1
1649946Neupogen 300 MCG per 1 ML InjectionSY3bc802bd-76b4-4f45-8571-a436ec26228e1
727545Neupogen 480 MCG per 0.8 ML Prefilled SyringeSY3bc802bd-76b4-4f45-8571-a436ec26228e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55513-924-01555130924010.5 mL in 1 SYRINGE0.5 mlHistorical
55513-924-105551309241010 SYRINGE in 1 BOX (55513-924-10) / .5 mL in 1 SYRINGE (55513-924-01) 10 syringe2000-10-020000-00-00NoNoCurrent
55513-924-205551309242010 SYRINGE in 1 BOX (55513-924-20) / .5 mL in 1 SYRINGE (55513-924-01) 10 syringe2025-10-01NoNoHistorical
55513-924-91555130924911 SYRINGE in 1 BOX (55513-924-91) / .5 mL in 1 SYRINGE1 syringe2000-10-020000-00-00NoNoCurrent