neupogen

Generic: filgrastim

Labeler: amgen, inc
NDC Directory HUMAN PRESCRIPTION DRUG BLA Inactive Finished

Drug Facts

Product Profile

Brand Name neupogen
Generic Name filgrastim
Labeler amgen, inc
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS SUBCUTANEOUS
Active Ingredients

filgrastim 300 ug/mL

Manufacturer
Amgen, Inc

Identifiers & Regulatory

Product NDC 55513-530
Product ID 55513-530_52115df1-de31-4353-a33b-5ca065af4e85
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA103353
Listing Expiration 2027-12-31
Marketing Start 1997-05-19

Pharmacologic Class

Established (EPC)
leukocyte growth factor [epc]
Chemical Structure
granulocyte colony-stimulating factor [cs]
Physiologic Effect
increased myeloid cell production [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 55513530
Hyphenated Format 55513-530

Supplemental Identifiers

UPC
0355513530101 0355513546102
UNII
PVI5M0M1GW
NUI
M0024696 N0000009451 N0000175666

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name neupogen (source: ndc)
Generic Name filgrastim (source: ndc)
Application Number BLA103353 (source: ndc)
Routes
INTRAVENOUS SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 300 ug/mL
source: ndc
Packaging
  • 10 VIAL in 1 PACKAGE (55513-530-10) / 1 mL in 1 VIAL (55513-530-01)
  • 10 VIAL in 1 PACKAGE (55513-530-20) / 1 mL in 1 VIAL (55513-530-01)
source: ndc

Packages (2)

55513-530-10 10 VIAL in 1 PACKAGE (55513-530-10) / 1 mL in 1 VIAL (55513-530-01) 55513-530-20 10 VIAL in 1 PACKAGE (55513-530-20) / 1 mL in 1 VIAL (55513-530-01)

Ingredients (1)

filgrastim (300 ug/mL)

Linked Drug Pages (1)

NEUPOGEN ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS", "SUBCUTANEOUS"], "spl_id": "52115df1-de31-4353-a33b-5ca065af4e85", "openfda": {"nui": ["M0024696", "N0000009451", "N0000175666"], "upc": ["0355513530101", "0355513546102"], "unii": ["PVI5M0M1GW"], "spl_set_id": ["97cc73cc-b5b7-458a-a933-77b00523e193"], "pharm_class_cs": ["Granulocyte Colony-Stimulating Factor [CS]"], "pharm_class_pe": ["Increased Myeloid Cell Production [PE]"], "pharm_class_epc": ["Leukocyte Growth Factor [EPC]"], "manufacturer_name": ["Amgen, Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL in 1 PACKAGE (55513-530-10)  / 1 mL in 1 VIAL (55513-530-01)", "package_ndc": "55513-530-10", "marketing_start_date": "19970519"}, {"sample": false, "description": "10 VIAL in 1 PACKAGE (55513-530-20)  / 1 mL in 1 VIAL (55513-530-01)", "package_ndc": "55513-530-20", "marketing_start_date": "20251001"}], "brand_name": "NEUPOGEN", "product_id": "55513-530_52115df1-de31-4353-a33b-5ca065af4e85", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Granulocyte Colony-Stimulating Factor [CS]", "Increased Myeloid Cell Production [PE]", "Leukocyte Growth Factor [EPC]"], "product_ndc": "55513-530", "generic_name": "Filgrastim", "labeler_name": "Amgen, Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "NEUPOGEN", "active_ingredients": [{"name": "FILGRASTIM", "strength": "300 ug/mL"}], "application_number": "BLA103353", "marketing_category": "BLA", "marketing_start_date": "19970519", "listing_expiration_date": "20271231"}