granix

Generic: tbo-filgrastim

Labeler: cephalon, llc
NDC Directory HUMAN PRESCRIPTION DRUG BLA Inactive Finished

Drug Facts

Product Profile

Brand Name granix
Generic Name tbo-filgrastim
Labeler cephalon, llc
Dosage Form INJECTION, SOLUTION
Routes
SUBCUTANEOUS
Active Ingredients

filgrastim 300 ug/.5mL

Manufacturer
Cephalon, LLC

Identifiers & Regulatory

Product NDC 63459-910
Product ID 63459-910_063f36a7-6f99-40fa-af02-8a5183c51e99
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA125294
Listing Expiration 2026-12-31
Marketing Start 2013-11-11

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 63459910
Hyphenated Format 63459-910

Supplemental Identifiers

RxCUI
1433768 1433771 1442681 1442683 2101456 2101459 2101464 2101465
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 granix (source: ndc)
Generic Name tbo-filgrastim (source: ndc)
Application Number BLA125294 (source: ndc)
Routes
SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 300 ug/.5mL
source: ndc
Packaging
  • 1 BLISTER PACK in 1 CARTON (63459-910-11) / 1 SYRINGE, GLASS in 1 BLISTER PACK (63459-910-12) / .5 mL in 1 SYRINGE, GLASS (63459-910-01)
  • 10 BLISTER PACK in 1 CARTON (63459-910-15) / 1 SYRINGE, GLASS in 1 BLISTER PACK (63459-910-12) / .5 mL in 1 SYRINGE, GLASS (63459-910-01)
  • 1 SYRINGE, GLASS in 1 CARTON (63459-910-17) / .5 mL in 1 SYRINGE, GLASS (63459-910-18)
  • 5 SYRINGE, GLASS in 1 CARTON (63459-910-36) / .5 mL in 1 SYRINGE, GLASS (63459-910-18)
source: ndc

Packages (4)

63459-910-11 1 BLISTER PACK in 1 CARTON (63459-910-11) / 1 SYRINGE, GLASS in 1 BLISTER PACK (63459-910-12) / .5 mL in 1 SYRINGE, GLASS (63459-910-01) 63459-910-15 10 BLISTER PACK in 1 CARTON (63459-910-15) / 1 SYRINGE, GLASS in 1 BLISTER PACK (63459-910-12) / .5 mL in 1 SYRINGE, GLASS (63459-910-01) 63459-910-17 1 SYRINGE, GLASS in 1 CARTON (63459-910-17) / .5 mL in 1 SYRINGE, GLASS (63459-910-18) 63459-910-36 5 SYRINGE, GLASS in 1 CARTON (63459-910-36) / .5 mL in 1 SYRINGE, GLASS (63459-910-18)

Ingredients (1)

filgrastim (300 ug/.5mL)

Linked Drug Pages (1)

GRANIX ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["SUBCUTANEOUS"], "spl_id": "063f36a7-6f99-40fa-af02-8a5183c51e99", "openfda": {"nui": ["M0024696", "N0000009451", "N0000175666"], "unii": ["PVI5M0M1GW"], "rxcui": ["1433768", "1433771", "1442681", "1442683", "2101456", "2101459", "2101464", "2101465"], "spl_set_id": ["df918ec2-0907-443f-a52a-b72866959644"], "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": ["Cephalon, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BLISTER PACK in 1 CARTON (63459-910-11)  / 1 SYRINGE, GLASS in 1 BLISTER PACK (63459-910-12)  / .5 mL in 1 SYRINGE, GLASS (63459-910-01)", "package_ndc": "63459-910-11", "marketing_start_date": "20131111"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (63459-910-15)  / 1 SYRINGE, GLASS in 1 BLISTER PACK (63459-910-12)  / .5 mL in 1 SYRINGE, GLASS (63459-910-01)", "package_ndc": "63459-910-15", "marketing_start_date": "20131111"}, {"sample": false, "description": "1 SYRINGE, GLASS in 1 CARTON (63459-910-17)  / .5 mL in 1 SYRINGE, GLASS (63459-910-18)", "package_ndc": "63459-910-17", "marketing_start_date": "20150302"}, {"sample": false, "description": "5 SYRINGE, GLASS in 1 CARTON (63459-910-36)  / .5 mL in 1 SYRINGE, GLASS (63459-910-18)", "package_ndc": "63459-910-36", "marketing_start_date": "20150302"}], "brand_name": "GRANIX", "product_id": "63459-910_063f36a7-6f99-40fa-af02-8a5183c51e99", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Granulocyte Colony-Stimulating Factor [CS]", "Increased Myeloid Cell Production [PE]", "Leukocyte Growth Factor [EPC]"], "product_ndc": "63459-910", "generic_name": "tbo-filgrastim", "labeler_name": "Cephalon, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "GRANIX", "active_ingredients": [{"name": "FILGRASTIM", "strength": "300 ug/.5mL"}], "application_number": "BLA125294", "marketing_category": "BLA", "marketing_start_date": "20131111", "listing_expiration_date": "20261231"}