Home NDC 69448-008 FILKRI
Product NDC 69448-008
11-digit product format 694480008
Labeler code 69448
Product ID 69448-008_6dd7213f-3c00-4539-9c76-96c904676827
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name filgrastim-laha
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS, SUBCUTANEOUS
Labeler Accord BioPharma Inc.,
Application BLA761027
Marketing category BLA
Marketing start 2026-06-29
Substance FILGRASTIM
Active strength 300 ug/.5mL
Pharmacologic classes Granulocyte Colony-Stimulating Factor [CS]; Increased Myeloid Cell Production [PE]; Leukocyte Growth Factor [EPC]
Listing certified through 2027-12-31
Current FDA listing Yes Additional Listing Data#
Finished product Yes
Brand name base FILKRI
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength FILGRASTIM 300 ug/.5mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination PVI5M0M1GW Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2747351 Internal RxNorm lookup 2747358 Internal RxNorm lookup 2747360 Internal RxNorm lookup 2747361 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 761027 Filkri filgrastim-laha 351(k) Biosimilar Rx 2026-08-01
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Status 69448-008-03 69448000803 10 SYRINGE in 1 BOX (69448-008-03) / .5 mL in 1 SYRINGE 10 syringe 2026-07-15 0 Current 69448-008-63 69448000863 1 SYRINGE in 1 BOX (69448-008-63) / .5 mL in 1 SYRINGE 1 syringe 2026-06-29 0 Current