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 480 ug/1.6mL

Manufacturer
Amgen, Inc

Identifiers & Regulatory

Product NDC 55513-546
Product ID 55513-546_cc41b9c3-f2de-416f-9396-acdc8dac69b9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA103353
Listing Expiration 2026-12-31
Marketing Start 1997-04-07

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 55513546
Hyphenated Format 55513-546

Supplemental Identifiers

RxCUI
727535 727537 727544 727545 1649944 1649946 1649963 1649964
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
  • 480 ug/1.6mL
source: ndc
Packaging
  • 10 VIAL in 1 BOX (55513-546-10) / 1.6 mL in 1 VIAL (55513-546-01)
  • 10 VIAL in 1 BOX (55513-546-20) / 1.6 mL in 1 VIAL (55513-546-01)
source: ndc

Packages (2)

55513-546-10 10 VIAL in 1 BOX (55513-546-10) / 1.6 mL in 1 VIAL (55513-546-01) 55513-546-20 10 VIAL in 1 BOX (55513-546-20) / 1.6 mL in 1 VIAL (55513-546-01)

Ingredients (1)

filgrastim (480 ug/1.6mL)

Linked Drug Pages (1)

NEUPOGEN ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS", "SUBCUTANEOUS"], "spl_id": "cc41b9c3-f2de-416f-9396-acdc8dac69b9", "openfda": {"nui": ["M0024696", "N0000009451", "N0000175666"], "upc": ["0355513530101", "0355513546102"], "unii": ["PVI5M0M1GW"], "rxcui": ["727535", "727537", "727544", "727545", "1649944", "1649946", "1649963", "1649964"], "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 BOX (55513-546-10)  / 1.6 mL in 1 VIAL (55513-546-01)", "package_ndc": "55513-546-10", "marketing_start_date": "19970407"}, {"sample": false, "description": "10 VIAL in 1 BOX (55513-546-20)  / 1.6 mL in 1 VIAL (55513-546-01)", "package_ndc": "55513-546-20", "marketing_start_date": "20251001"}], "brand_name": "NEUPOGEN", "product_id": "55513-546_cc41b9c3-f2de-416f-9396-acdc8dac69b9", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Granulocyte Colony-Stimulating Factor [CS]", "Increased Myeloid Cell Production [PE]", "Leukocyte Growth Factor [EPC]"], "product_ndc": "55513-546", "generic_name": "Filgrastim", "labeler_name": "Amgen, Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "NEUPOGEN", "active_ingredients": [{"name": "FILGRASTIM", "strength": "480 ug/1.6mL"}], "application_number": "BLA103353", "marketing_category": "BLA", "marketing_start_date": "19970407", "listing_expiration_date": "20261231"}