REPATHA

Product NDC: 55513-760
Requested package NDC: 55513-760-03
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
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	55513-760	55513-760-03	D	Discontinued by firm		2026-08-11

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 date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
55513-760-01	ML - Milliliter	55513-760	66f28417-7fc2-4e38-98ba-5fc33a31360f	1	2015-09-10
55513-760-02	ML - Milliliter	55513-760	54a780be-053b-4f73-8e35-e1234a2c7372	1	2015-09-10

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
EVOLOCUMAB	ACTIVE INGREDIENT	LKC0U3A8NJ	REPATHA (EVOLOCUMAB) INJECTION, SOLUTION [AMGEN INC]	6
EVOLOCUMAB	ACTIVE MOIETY	LKC0U3A8NJ	REPATHA (EVOLOCUMAB) INJECTION, SOLUTION [AMGEN INC]	6
ACETATE ION	INACTIVE INGREDIENT	569DQM74SC	REPATHA (EVOLOCUMAB) INJECTION, SOLUTION [AMGEN INC]	6
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	REPATHA (EVOLOCUMAB) INJECTION, SOLUTION [AMGEN INC]	6
PROLINE	INACTIVE INGREDIENT	9DLQ4CIU6V	REPATHA (EVOLOCUMAB) INJECTION, SOLUTION [AMGEN INC]	6
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	REPATHA (EVOLOCUMAB) INJECTION, SOLUTION [AMGEN INC]	6
WATER	INACTIVE INGREDIENT	059QF0KO0R	REPATHA (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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
REPATHA	EVOLOCUMAB	Amgen USA Inc.	cd61e902-166d-4aa6-9f3c-a18c1008d07e	2026-07-16	Warnings, Adverse reactions	Exact identifier application number: BLA125522

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLA	Proprietary name	Proper name	License type	Status	Latest source
125522	Repatha	evolocumab	351(a)	Rx	2026-07-01

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
LKC0U3A8NJ	EVOLOCUMAB	1256937-27-5	EVOLOCUMAB

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
55513-760-03	55513076003	3 SYRINGE in 1 CARTON (55513-760-03) > 1 mL in 1 SYRINGE	3 syringe	2015-08-31	0000-00-00	No	No	Current