FDA.reportPublic FDA data

REPATHA

Product NDC
55513-770
Requested package NDC
55513-770-01
11-digit product format
555130770
Labeler code
55513
Product ID
55513-770_e93d54e9-7f1c-4f07-b217-5ddcef89e16e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Evolocumab
Dosage form
KIT
Labeler
Amgen Inc
Application
BLA125522
Marketing category
BLA
Marketing start
2016-08-01
Marketing end
0000-00-00
Active strength
0
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage55513-77055513-770-01DDiscontinued by firm2026-08-11

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 9 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
EVOLOCUMABACTIVE INGREDIENTLKC0U3A8NJREPATHA (EVOLOCUMAB) INJECTION, SOLUTION [AMGEN INC]6
EVOLOCUMABACTIVE MOIETYLKC0U3A8NJREPATHA (EVOLOCUMAB) INJECTION, SOLUTION [AMGEN INC]6
ACETATE IONINACTIVE INGREDIENT569DQM74SCREPATHA (EVOLOCUMAB) INJECTION, SOLUTION [AMGEN INC]6
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HREPATHA (EVOLOCUMAB) INJECTION, SOLUTION [AMGEN INC]6
PROLINEINACTIVE INGREDIENT9DLQ4CIU6VREPATHA (EVOLOCUMAB) INJECTION, SOLUTION [AMGEN INC]6
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IREPATHA (EVOLOCUMAB) INJECTION, SOLUTION [AMGEN INC]6
WATERINACTIVE INGREDIENT059QF0KO0RREPATHA (EVOLOCUMAB) INJECTION, SOLUTION [AMGEN INC]6

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
REPATHAEVOLOCUMABAmgen USA Inc.cd61e902-166d-4aa6-9f3c-a18c1008d07e2026-07-16Warnings, Adverse reactionsExact identifier
application number: BLA125522

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125522Repathaevolocumab351(a)Rx2026-07-01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55513-770-01555130770011 KIT in 1 CARTON (55513-770-01) * 1 CARTRIDGE in 1 TRAY > 3.5 mL in 1 CARTRIDGE1 kit2016-08-010000-00-00NoNoCurrent