releuko

Generic: filgrastim

Labeler: amneal pharmaceuticals llc
NDC Directory HUMAN PRESCRIPTION DRUG BLA Inactive Finished

Drug Facts

Product Profile

Brand Name releuko
Generic Name filgrastim
Labeler amneal pharmaceuticals llc
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS SUBCUTANEOUS
Active Ingredients

filgrastim 300 ug/.5mL

Manufacturer
Amneal Pharmaceuticals LLC

Identifiers & Regulatory

Product NDC 70121-1568
Product ID 70121-1568_7dd755fd-d4fe-431a-97a2-1ded5cf1a24b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA761082
Listing Expiration 2026-12-31
Marketing Start 2022-02-25

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 701211568
Hyphenated Format 70121-1568

Supplemental Identifiers

RxCUI
2595944 2595950 2595953 2595957 2595959 2595960 2595961 2595962
UPC
0370121156970 0370121156819 0370121157014 0370121156871 0370121157175 0370121157076
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 releuko (source: ndc)
Generic Name filgrastim (source: ndc)
Application Number BLA761082 (source: ndc)
Routes
INTRAVENOUS SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 300 ug/.5mL
source: ndc
Packaging
  • 1 SYRINGE in 1 BOX (70121-1568-1) / .5 mL in 1 SYRINGE
  • 10 SYRINGE in 1 BOX (70121-1568-7) / .5 mL in 1 SYRINGE
source: ndc

Packages (2)

70121-1568-1 1 SYRINGE in 1 BOX (70121-1568-1) / .5 mL in 1 SYRINGE 70121-1568-7 10 SYRINGE in 1 BOX (70121-1568-7) / .5 mL in 1 SYRINGE

Ingredients (1)

filgrastim (300 ug/.5mL)

Linked Drug Pages (1)

RELEUKO ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS", "SUBCUTANEOUS"], "spl_id": "7dd755fd-d4fe-431a-97a2-1ded5cf1a24b", "openfda": {"nui": ["M0024696", "N0000009451", "N0000175666"], "upc": ["0370121156970", "0370121156819", "0370121157014", "0370121156871", "0370121157175", "0370121157076"], "unii": ["PVI5M0M1GW"], "rxcui": ["2595944", "2595950", "2595953", "2595957", "2595959", "2595960", "2595961", "2595962"], "spl_set_id": ["74e1ec6e-1630-4654-895c-2bd355f939e7"], "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": ["Amneal Pharmaceuticals LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 SYRINGE in 1 BOX (70121-1568-1)  / .5 mL in 1 SYRINGE", "package_ndc": "70121-1568-1", "marketing_start_date": "20220225"}, {"sample": false, "description": "10 SYRINGE in 1 BOX (70121-1568-7)  / .5 mL in 1 SYRINGE", "package_ndc": "70121-1568-7", "marketing_start_date": "20220225"}], "brand_name": "RELEUKO", "product_id": "70121-1568_7dd755fd-d4fe-431a-97a2-1ded5cf1a24b", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Granulocyte Colony-Stimulating Factor [CS]", "Increased Myeloid Cell Production [PE]", "Leukocyte Growth Factor [EPC]"], "product_ndc": "70121-1568", "generic_name": "Filgrastim", "labeler_name": "Amneal Pharmaceuticals LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "RELEUKO", "active_ingredients": [{"name": "FILGRASTIM", "strength": "300 ug/.5mL"}], "application_number": "BLA761082", "marketing_category": "BLA", "marketing_start_date": "20220225", "listing_expiration_date": "20261231"}