FDA.reportPublic FDA data

FILKRI

Product NDC
69448-009
Requested package NDC
69448-009-03
11-digit product format
694480009
Labeler code
69448
Product ID
69448-009_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
2026-07-15
Substance
FILGRASTIM
Active strength
480 ug/.8mL
Pharmacologic classes
Granulocyte Colony-Stimulating Factor [CS], Increased Myeloid Cell Production [PE], Leukocyte Growth Factor [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
FILKRI
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FILGRASTIM480 ug/.8mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
PVI5M0M1GWInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2747351Internal RxNorm lookup
2747358Internal RxNorm lookup
2747360Internal RxNorm lookup
2747361Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
9c2f9573-08fd-43be-a489-8a5e5d8ab2ffAvailable on FDA.report

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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FILKRIFILGRASTIM-LAHAAccord BioPharma Inc.,9c2f9573-08fd-43be-a489-8a5e5d8ab2ff2026-07-10Warnings, Adverse reactionsExact identifier
application number: BLA761027
ndc (package): 69448-009-03
ndc (product): 69448-009
ndc11 (package): 69448000903

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761027Filkrifilgrastim-laha351(k) BiosimilarRx2026-09-01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69448-009-036944800090310 SYRINGE in 1 BOX (69448-009-03) / .8 mL in 1 SYRINGE10 syringe2026-07-15NoNoCurrent