NEUPOGEN

Product NDC: 55513-209
11-digit product format: 555130209
Labeler code: 55513
Product ID: 55513-209_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: 480 ug/.8mL
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
Ingredient	Strength
FILGRASTIM	480 ug/.8mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
PVI5M0M1GW	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 8 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
727535	Internal RxNorm lookup
727537	Internal RxNorm lookup
727544	Internal RxNorm lookup
727545	Internal RxNorm lookup
1649944	Internal RxNorm lookup
1649946	Internal RxNorm lookup
1649963	Internal RxNorm lookup
1649964	Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
97cc73cc-b5b7-458a-a933-77b00523e193	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
0f366651-2cb6-4932-a760-2ae84fd8fbff	Product name	1	20230703
3b1c6100-f679-4300-94a6-3b3fc05b0c44	Product name	1	20230110
48747306-602a-42cc-957b-5b0c69158eee	Product name	1	20180604
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578b	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
55513-209-01	NEUPOGEN	0.8 mL in 1 SYRINGE	INJECTION, SOLUTION	0.8	164
55513-209-10	NEUPOGEN	10 in 1 BOX	INJECTION, SOLUTION	10	164
55513-209-20	NEUPOGEN	10 in 1 BOX	INJECTION, SOLUTION	10	164
55513-209-91	NEUPOGEN	0.8 mL in 1 SYRINGE	INJECTION, SOLUTION	0.8	164
55513-209-91	NEUPOGEN	1 in 1 BOX	INJECTION, SOLUTION	1	164

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
55513-209-01	ML - Milliliter	55513-209	c3617246-0d6e-4b4a-b403-80015977f496	1	2012-07-24
55513-209-10	ML - Milliliter	55513-209	36e28938-e574-47a9-9413-efa9fa0a9405	1	2012-07-24
55513-209-20	ML - Milliliter	55513-209	30bce519-f07e-41f6-8e4c-2aa51ff543fb	1	2026-02-05
55513-209-91	ML - Milliliter	55513-209	15d5c371-7741-4fc1-9d18-8a76fcbb9159	1	2014-05-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
FILGRASTIM, LICENSE HOLDER UNSPECIFIED	ACTIVE INGREDIENT	PVI5M0M1GW	NEUPOGEN (FILGRASTIM) INJECTION, SOLUTION [AMGEN INC]	144
FILGRASTIM, LICENSE HOLDER UNSPECIFIED	ACTIVE MOIETY	PVI5M0M1GW	NEUPOGEN (FILGRASTIM) INJECTION, SOLUTION [AMGEN INC]	144
ACETIC ACID	INACTIVE INGREDIENT	Q40Q9N063P	NEUPOGEN (FILGRASTIM) INJECTION, SOLUTION [AMGEN INC]	144
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	NEUPOGEN (FILGRASTIM) INJECTION, SOLUTION [AMGEN INC]	144
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	NEUPOGEN (FILGRASTIM) INJECTION, SOLUTION [AMGEN INC]	144
SORBITOL	INACTIVE INGREDIENT	506T60A25R	NEUPOGEN (FILGRASTIM) INJECTION, SOLUTION [AMGEN INC]	144
WATER	INACTIVE INGREDIENT	059QF0KO0R	NEUPOGEN (FILGRASTIM) INJECTION, SOLUTION [AMGEN INC]	144
FILGRASTIM	ACTIVE INGREDIENT	PVI5M0M1GW	NEUPOGEN (FILGRASTIM) INJECTION, SOLUTION [PHYSICIANS TOTAL CARE, INC.]	1
FILGRASTIM	ACTIVE MOIETY	PVI5M0M1GW	NEUPOGEN (FILGRASTIM) INJECTION, SOLUTION [PHYSICIANS TOTAL CARE, INC.]	1
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	NEUPOGEN (FILGRASTIM) INJECTION, SOLUTION [PHYSICIANS TOTAL CARE, INC.]	1
SODIUM POLYMETAPHOSPHATE	INACTIVE INGREDIENT	P1BM4ZH95L	NEUPOGEN (FILGRASTIM) INJECTION, SOLUTION [PHYSICIANS TOTAL CARE, INC.]	1
SORBITOL	INACTIVE INGREDIENT	506T60A25R	NEUPOGEN (FILGRASTIM) INJECTION, SOLUTION [PHYSICIANS TOTAL CARE, INC.]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	NEUPOGEN (FILGRASTIM) INJECTION, SOLUTION [PHYSICIANS TOTAL CARE, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55513-209	NEUPOGEN (FILGRASTIM) INJECTION, SOLUTION [AMGEN, INC]	162	Current NDC, Legacy NDC, 5 package rows	20250503_97cc73cc-b5b7-458a-a933-77b00523e193.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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
NEUPOGEN	FILGRASTIM	Amgen, Inc	97cc73cc-b5b7-458a-a933-77b00523e193	2026-07-23	Warnings, Adverse reactions	Exact identifier application number: BLA103353 ndc (product): 55513-209

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLA	Proprietary name	Proper name	License type	Status	Latest source
103353	Neupogen	filgrastim	351(a)	Rx	2026-06-01

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
PVI5M0M1GW	FILGRASTIM	121181-53-1	FILGRASTIM

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
727535	filgrastim 300 MCG in 0.5 ML Prefilled Syringe	PSN	97cc73cc-b5b7-458a-a933-77b00523e193	164
1649944	filgrastim 300 MCG in 1 ML Injection	PSN	97cc73cc-b5b7-458a-a933-77b00523e193	164
727544	filgrastim 480 MCG in 0.8 ML Prefilled Syringe	PSN	97cc73cc-b5b7-458a-a933-77b00523e193	164
1649963	filgrastim 480 MCG in 1.6 ML Injection	PSN	97cc73cc-b5b7-458a-a933-77b00523e193	164
727537	Neupogen 300 MCG in 0.5 ML Prefilled Syringe	PSN	97cc73cc-b5b7-458a-a933-77b00523e193	164
1649946	Neupogen 300 MCG in 1 ML Injection	PSN	97cc73cc-b5b7-458a-a933-77b00523e193	164
727545	Neupogen 480 MCG in 0.8 ML Prefilled Syringe	PSN	97cc73cc-b5b7-458a-a933-77b00523e193	164
1649964	Neupogen 480 MCG in 1.6 ML Injection	PSN	97cc73cc-b5b7-458a-a933-77b00523e193	164
727537	0.5 ML filgrastim 0.6 MG/ML Prefilled Syringe [Neupogen]	SBD	97cc73cc-b5b7-458a-a933-77b00523e193	164
727545	0.8 ML filgrastim 0.6 MG/ML Prefilled Syringe [Neupogen]	SBD	97cc73cc-b5b7-458a-a933-77b00523e193	164
1649946	1 ML filgrastim 0.3 MG/ML Injection [Neupogen]	SBD	97cc73cc-b5b7-458a-a933-77b00523e193	164
1649964	1.6 ML filgrastim 0.3 MG/ML Injection [Neupogen]	SBD	97cc73cc-b5b7-458a-a933-77b00523e193	164
727535	0.5 ML filgrastim 0.6 MG/ML Prefilled Syringe	SCD	97cc73cc-b5b7-458a-a933-77b00523e193	164
727544	0.8 ML filgrastim 0.6 MG/ML Prefilled Syringe	SCD	97cc73cc-b5b7-458a-a933-77b00523e193	164
1649944	1 ML filgrastim 0.3 MG/ML Injection	SCD	97cc73cc-b5b7-458a-a933-77b00523e193	164
1649963	1.6 ML filgrastim 0.3 MG/ML Injection	SCD	97cc73cc-b5b7-458a-a933-77b00523e193	164
727537	0.5 ML Neupogen 0.6 MG/ML Prefilled Syringe	SY	97cc73cc-b5b7-458a-a933-77b00523e193	164
727545	0.8 ML Neupogen 0.6 MG/ML Prefilled Syringe	SY	97cc73cc-b5b7-458a-a933-77b00523e193	164
1649946	1 ML Neupogen 0.3 MG/ML Injection	SY	97cc73cc-b5b7-458a-a933-77b00523e193	164
1649964	1.6 ML Neupogen 0.3 MG/ML Injection	SY	97cc73cc-b5b7-458a-a933-77b00523e193	164
727535	filgrastim 0.3 MG per 0.5 ML Prefilled Syringe	SY	97cc73cc-b5b7-458a-a933-77b00523e193	164
727544	filgrastim 0.48 MG per 0.8 ML Prefilled Syringe	SY	97cc73cc-b5b7-458a-a933-77b00523e193	164
727535	filgrastim 300 MCG per 0.5 ML Prefilled Syringe	SY	97cc73cc-b5b7-458a-a933-77b00523e193	164
1649944	filgrastim 300 MCG per 1 ML Injection	SY	97cc73cc-b5b7-458a-a933-77b00523e193	164
727544	filgrastim 480 MCG per 0.8 ML Prefilled Syringe	SY	97cc73cc-b5b7-458a-a933-77b00523e193	164
1649963	filgrastim 480 MCG per 1.6 ML Injection	SY	97cc73cc-b5b7-458a-a933-77b00523e193	164
727537	Neupogen 300 MCG per 0.5 ML Prefilled Syringe	SY	97cc73cc-b5b7-458a-a933-77b00523e193	164
1649946	Neupogen 300 MCG per 1 ML Injection	SY	97cc73cc-b5b7-458a-a933-77b00523e193	164
727545	Neupogen 480 MCG per 0.8 ML Prefilled Syringe	SY	97cc73cc-b5b7-458a-a933-77b00523e193	164
1649964	Neupogen 480 MCG per 1.6 ML Injection	SY	97cc73cc-b5b7-458a-a933-77b00523e193	164
727535	filgrastim 300 MCG in 0.5 ML Prefilled Syringe	PSN	3bc802bd-76b4-4f45-8571-a436ec26228e	1
1649944	filgrastim 300 MCG in 1 ML Injection	PSN	3bc802bd-76b4-4f45-8571-a436ec26228e	1
727544	filgrastim 480 MCG in 0.8 ML Prefilled Syringe	PSN	3bc802bd-76b4-4f45-8571-a436ec26228e	1
727537	Neupogen 300 MCG in 0.5 ML Prefilled Syringe	PSN	3bc802bd-76b4-4f45-8571-a436ec26228e	1
1649946	Neupogen 300 MCG in 1 ML Injection	PSN	3bc802bd-76b4-4f45-8571-a436ec26228e	1
727545	Neupogen 480 MCG in 0.8 ML Prefilled Syringe	PSN	3bc802bd-76b4-4f45-8571-a436ec26228e	1
727537	0.5 ML filgrastim 0.6 MG/ML Prefilled Syringe [Neupogen]	SBD	3bc802bd-76b4-4f45-8571-a436ec26228e	1
727545	0.8 ML filgrastim 0.6 MG/ML Prefilled Syringe [Neupogen]	SBD	3bc802bd-76b4-4f45-8571-a436ec26228e	1
1649946	1 ML filgrastim 0.3 MG/ML Injection [Neupogen]	SBD	3bc802bd-76b4-4f45-8571-a436ec26228e	1
727535	0.5 ML filgrastim 0.6 MG/ML Prefilled Syringe	SCD	3bc802bd-76b4-4f45-8571-a436ec26228e	1
727544	0.8 ML filgrastim 0.6 MG/ML Prefilled Syringe	SCD	3bc802bd-76b4-4f45-8571-a436ec26228e	1
1649944	1 ML filgrastim 0.3 MG/ML Injection	SCD	3bc802bd-76b4-4f45-8571-a436ec26228e	1
727537	0.5 ML Neupogen 0.6 MG/ML Prefilled Syringe	SY	3bc802bd-76b4-4f45-8571-a436ec26228e	1
727545	0.8 ML Neupogen 0.6 MG/ML Prefilled Syringe	SY	3bc802bd-76b4-4f45-8571-a436ec26228e	1
1649946	1 ML Neupogen 0.3 MG/ML Injection	SY	3bc802bd-76b4-4f45-8571-a436ec26228e	1
727535	filgrastim 0.3 MG per 0.5 ML Prefilled Syringe	SY	3bc802bd-76b4-4f45-8571-a436ec26228e	1
727544	filgrastim 0.48 MG per 0.8 ML Prefilled Syringe	SY	3bc802bd-76b4-4f45-8571-a436ec26228e	1
727535	filgrastim 300 MCG per 0.5 ML Prefilled Syringe	SY	3bc802bd-76b4-4f45-8571-a436ec26228e	1
1649944	filgrastim 300 MCG per 1 ML Injection	SY	3bc802bd-76b4-4f45-8571-a436ec26228e	1
727544	filgrastim 480 MCG per 0.8 ML Prefilled Syringe	SY	3bc802bd-76b4-4f45-8571-a436ec26228e	1
727537	Neupogen 300 MCG per 0.5 ML Prefilled Syringe	SY	3bc802bd-76b4-4f45-8571-a436ec26228e	1
1649946	Neupogen 300 MCG per 1 ML Injection	SY	3bc802bd-76b4-4f45-8571-a436ec26228e	1
727545	Neupogen 480 MCG per 0.8 ML Prefilled Syringe	SY	3bc802bd-76b4-4f45-8571-a436ec26228e	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
55513-209-01	55513020901	0.8 mL in 1 SYRINGE	0.8 ml					Historical
55513-209-10	55513020910	10 SYRINGE in 1 BOX (55513-209-10) / .8 mL in 1 SYRINGE (55513-209-01)	10 syringe	2000-10-02	0000-00-00	No	No	Current
55513-209-20	55513020920	10 SYRINGE in 1 BOX (55513-209-20) / .8 mL in 1 SYRINGE (55513-209-01)	10 syringe	2025-10-01		No	No	Current
55513-209-91	55513020991	1 SYRINGE in 1 BOX (55513-209-91) / .8 mL in 1 SYRINGE	1 syringe	2000-10-02	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
NEUPOGEN	Amgen, Inc \| Amgen Manufacturing Limited LLC	2026-07-23	HUMAN PRESCRIPTION DRUG LABEL	166
Neupogen - Physicians Total Care, Inc.	Physicians Total Care, Inc.	2009-12-02	HUMAN PRESCRIPTION DRUG LABEL	1