FDA.reportPublic FDA data

BKEMV

Product NDC
55513-180
11-digit product format
555130180
Labeler code
55513
Product ID
55513-180_20150720-3435-4d6c-8eb1-55e6bc56cdce
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
eculizumab-aeeb
Dosage form
INJECTION, SOLUTION, CONCENTRATE
Route
INTRAVENOUS
Labeler
Amgen Inc
Application
BLA761333
Marketing category
BLA
Marketing start
2025-03-01
Substance
ECULIZUMAB
Active strength
300 mg/30mL
Pharmacologic classes
Complement Inhibitor [EPC], Complement Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ECULIZUMAB300 mg/30mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
A3ULP0F556Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2706351Internal RxNorm lookup
2706358Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
002f9748-b0e8-4b6e-a38b-56930a839491Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fd421817-98f6-4a57-87da-64fa00361661Product name120250616
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
1944fe02-2140-486a-967c-ad54bb2a479aProduct name120171212
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55513-180-01BKEMV30 mL in 1 VIALINJECTION, SOLUTION, CONCENTRATE307
55513-180-01BKEMV1 in 1 CARTONINJECTION, SOLUTION, CONCENTRATE17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55513-180-01ML - Milliliter55513-180d05f6b7e-c960-4fd8-9379-0bc6b732360412025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55513-180BKEMV (ECULIZUMAB-AEEB) INJECTION, SOLUTION, CONCENTRATE [AMGEN INC]5Current NDC, 2 package rows20250302_002f9748-b0e8-4b6e-a38b-56930a839491.zip

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
BKEMVECULIZUMAB-AEEBAmgen Inc002f9748-b0e8-4b6e-a38b-56930a8394912026-07-02Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA761333
ndc (product): 55513-180

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761333Bkemveculizumab-aeeb351(k) InterchangeableRx2026-06-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2706358BKEMV 300 MG in 30 ML InjectionPSN002f9748-b0e8-4b6e-a38b-56930a8394917
2706351eculizumab-aeeb 300 MG in 30 ML InjectionPSN002f9748-b0e8-4b6e-a38b-56930a8394917
270635830 ML eculizumab-aeeb 10 MG/ML Injection [Bkemv]SBD002f9748-b0e8-4b6e-a38b-56930a8394917
270635130 ML eculizumab-aeeb 10 MG/ML InjectionSCD002f9748-b0e8-4b6e-a38b-56930a8394917
2706358Bkemv 300 MG per 30 ML InjectionSY002f9748-b0e8-4b6e-a38b-56930a8394917
2706351eculizumab-aeeb 300 MG per 30 ML InjectionSY002f9748-b0e8-4b6e-a38b-56930a8394917

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
55513-180-01555130180011 VIAL in 1 CARTON (55513-180-01) / 30 mL in 1 VIAL1 vial2025-03-01NoNoCurrent