FDA.reportPublic FDA data

YARTEMLEA

Product NDC
62225-300
11-digit product format
622250300
Labeler code
62225
Product ID
62225-300_48da2b07-9b4c-7b5f-e063-6394a90a7b62
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
narsoplimab
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Omeros Corporation
Application
BLA761152
Marketing category
BLA
Marketing start
2026-01-20
Substance
NARSOPLIMAB
Active strength
370 mg/2mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NARSOPLIMAB370 mg/2mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
FT24ZQQ5RPInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2732298Internal RxNorm lookup
2732305Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
f8ff990a-0d2e-433f-9615-b9b097448991Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
1681bc73-b05f-12c3-1075-382ae39f449cProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62225-300-00YARTEMLEA2 mL in 1 VIALINJECTION26
62225-300-00YARTEMLEA1 in 1 CARTONINJECTION16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62225-300-00ML - Milliliter62225-300615dff7f-abfd-40c7-93e2-4efb0df0c5eb12026-02-05

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
YARTEMLEANARSOPLIMABOmeros Corporationf8ff990a-0d2e-433f-9615-b9b0974489912026-01-20Warnings, Adverse reactionsExact identifier
application number: BLA761152
ndc (product): 62225-300

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761152Yartemleanarsoplimab-wuug351(a)Rx2026-07-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2732298narsoplimab-wuug 370 MG in 2 ML InjectionPSNf8ff990a-0d2e-433f-9615-b9b0974489916
2732305YARTEMLEA 370 MG in 2 ML InjectionPSNf8ff990a-0d2e-433f-9615-b9b0974489916
27323052 ML narsoplimab-wuug 185 MG/ML Injection [Yartemlea]SBDf8ff990a-0d2e-433f-9615-b9b0974489916
27322982 ML narsoplimab-wuug 185 MG/ML InjectionSCDf8ff990a-0d2e-433f-9615-b9b0974489916
27323052 ML Yartemlea 185 MG/ML InjectionSYf8ff990a-0d2e-433f-9615-b9b0974489916
2732298narsoplimab-wuug 370 MG per 2 ML InjectionSYf8ff990a-0d2e-433f-9615-b9b0974489916
2732305Yartemlea 370 MG per 2 ML InjectionSYf8ff990a-0d2e-433f-9615-b9b0974489916

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
62225-300-00622250300001 VIAL in 1 CARTON (62225-300-00) / 2 mL in 1 VIAL1 vial2026-01-20NoNoCurrent