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 Identifiers#

Field, Values table
FieldValues
UniiA3ULP0F556
Rxcui2706338, 2706345

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

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-DOSE2025-04-07NoNoHistorical