FDA.reportPublic FDA data

REPATHA

Product NDC
55513-760
Requested package NDC
55513-760-91
11-digit product format
555130760
Labeler code
55513
Product ID
55513-760_e93d54e9-7f1c-4f07-b217-5ddcef89e16e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Evolocumab
Dosage form
INJECTION, SOLUTION
Route
SUBCUTANEOUS
Labeler
Amgen Inc
Application
BLA125522
Marketing category
BLA
Marketing start
2015-08-31
Marketing end
0000-00-00
Substance
EVOLOCUMAB
Active strength
140 mg/mL
Pharmacologic classes
Antibodies, Monoclonal [CS], PCSK9 Inhibitor [EPC], PCSK9 Inhibitors [MoA]
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 packagepackage55513-76055513-760-91DDiscontinued by firm2026-11-06

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…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55513-760-01ML - Milliliter55513-76066f28417-7fc2-4e38-98ba-5fc33a31360f12015-09-10
55513-760-02ML - Milliliter55513-76054a780be-053b-4f73-8e35-e1234a2c737212015-09-10

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

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125522Repathaevolocumab351(a)Rx2026-10-01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55513-760-91555130760911 SYRINGE in 1 CARTON (55513-760-91) > 1 mL in 1 SYRINGE1 syringe2015-08-310000-00-00YesNoCurrent