FDA.reportPublic FDA data

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

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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 (product): 69448-008

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FILGRASTIM300 ug/.5mL

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

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761027Filkrifilgrastim-laha351(k) BiosimilarRx2026-06-01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleStatus
69448-008-036944800080310 SYRINGE in 1 BOX (69448-008-03) / .5 mL in 1 SYRINGE10 syringe2026-07-150Current
69448-008-63694480008631 SYRINGE in 1 BOX (69448-008-63) / .5 mL in 1 SYRINGE1 syringe2026-06-290Current