NEUPOGEN

Product NDC: 55513-530
11-digit product format: 555130530
Labeler code: 55513
Product ID: 55513-530_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: 1997-05-19
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: 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	300 ug/mL

Harmonized Identifiers#

Field, Values table
Field	Values
Unii	PVI5M0M1GW
Rxcui	727535, 727537, 727544, 727545, 1649944, 1649946, 1649963, 1649964

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
55513-530-01	NEUPOGEN	1 mL in 1 VIAL	INJECTION, SOLUTION	1	164
55513-530-10	NEUPOGEN	10 in 1 PACKAGE	INJECTION, SOLUTION	10	164
55513-530-20	NEUPOGEN	10 in 1 PACKAGE	INJECTION, SOLUTION	10	164

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
55513-530-01	ML - Milliliter	55513-530	3ac4a5bf-6d3c-4616-9604-fff632ef1cc0	1	2012-07-24
55513-530-10	ML - Milliliter	55513-530	4e61c10a-6582-4756-80d5-abfa27f886a8	1	2012-07-24
55513-530-20	ML - Milliliter	55513-530	8d39ba9a-d325-4b4b-bfc0-61298a414e99	1	2026-05-22

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
55513-530	NEUPOGEN (FILGRASTIM) INJECTION, SOLUTION [AMGEN, INC]	162	Current NDC, Legacy NDC, 3 package rows	20250503_97cc73cc-b5b7-458a-a933-77b00523e193.zip

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
55513-530-01	55513053001	1 mL in 1 VIAL	1 ml					Historical
55513-530-10	55513053010	10 VIAL in 1 PACKAGE (55513-530-10) / 1 mL in 1 VIAL (55513-530-01)	10 vial	1997-05-19	0000-00-00	No	No	Current
55513-530-20	55513053020	10 VIAL in 1 PACKAGE (55513-530-20) / 1 mL in 1 VIAL (55513-530-01)	10 vial	2025-10-01		No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
NEUPOGEN	Amgen, Inc \| Amgen Manufacturing Limited LLC	2026-03-08	HUMAN PRESCRIPTION DRUG LABEL	164
Neupogen - Physicians Total Care, Inc.	Physicians Total Care, Inc.	2009-12-02	HUMAN PRESCRIPTION DRUG LABEL	1

NEUPOGEN

Additional Listing Data#

Related Records#

Active Ingredients#

Harmonized Identifiers#

DailyMed Product Concepts#

DailyMed Package Descriptions#

DailyMed Billing Units#

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

Related Records#

Related UNII Ingredients#

DailyMed RxNorm Mappings#

Packages#

Related DailyMed Labels#