FDA.reportPublic FDA data

EPYSQLI

Product NDC
51759-208
11-digit product format
517590208
Labeler code
51759
Product ID
51759-208_52e8a576-7ee1-4d7b-9814-62d91fb62df1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Eculizumab-aagh
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Teva Pharmaceuticals USA, Inc.
Application
BLA761340
Marketing category
BLA
Marketing start
2025-04-07
Substance
ECULIZUMAB
Active strength
300 mg/30mL
Pharmacologic classes
Complement Inhibitor [EPC], Complement Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
EPYSQLI
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
2706338Internal RxNorm lookup
2706345Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
1fa1aa80-1c59-44d4-9841-b6c52882651bAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fd421817-98f6-4a57-87da-64fa00361661Product name120250616
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
1944fe02-2140-486a-967c-ad54bb2a479aProduct name120171212
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51759-208-13EPYSQLI30 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION304
51759-208-13EPYSQLI1 in 1 CARTONINJECTION, SOLUTION14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51759-208-13ML - Milliliter51759-208d2d4450f-9a16-4f98-81eb-9be427a4dad312025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51759-208EPYSQLI (ECULIZUMAB-AAGH) INJECTION, SOLUTION [TEVA PHARMACEUTICALS USA, INC.]2Current NDC, 2 package rows20250408_1fa1aa80-1c59-44d4-9841-b6c52882651b.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
EPYSQLIECULIZUMAB-AAGHTeva Pharmaceuticals USA, Inc.1fa1aa80-1c59-44d4-9841-b6c52882651b2026-07-06Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA761340
ndc (product): 51759-208

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761340Epysqlieculizumab-aagh351(k) InterchangeableRx2026-06-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2706338eculizumab-aagh 300 MG in 30 ML InjectionPSN1fa1aa80-1c59-44d4-9841-b6c52882651b4
2706345Epysqli 300 MG in 30 ML InjectionPSN1fa1aa80-1c59-44d4-9841-b6c52882651b4
270634530 ML eculizumab-aagh 10 MG/ML Injection [Epysqli]SBD1fa1aa80-1c59-44d4-9841-b6c52882651b4
270633830 ML eculizumab-aagh 10 MG/ML InjectionSCD1fa1aa80-1c59-44d4-9841-b6c52882651b4
2706338eculizumab-aagh 300 MG per 30 ML InjectionSY1fa1aa80-1c59-44d4-9841-b6c52882651b4
2706345Epysqli 300 MG per 30 ML InjectionSY1fa1aa80-1c59-44d4-9841-b6c52882651b4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
51759-208-13517590208131 VIAL, SINGLE-DOSE in 1 CARTON (51759-208-13) / 30 mL in 1 VIAL, SINGLE-DOSE2025-04-07NoNoCurrent