FDA.reportPublic FDA data

REPATHA

Product NDC
72511-143
11-digit product format
725110143
Labeler code
72511
Product ID
72511-143_8c3243f2-030c-427a-8169-43ab93f493d0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Evolocumab
Dosage form
INJECTION, SOLUTION
Route
SUBCUTANEOUS
Labeler
Amgen USA Inc.
Application
BLA125522
Marketing category
BLA
Marketing start
2026-07-13
Substance
EVOLOCUMAB
Active strength
140 mg/mL
Pharmacologic classes
Antibodies; Monoclonal [CS]; PCSK9 Inhibitor [EPC]; PCSK9 Inhibitors [MoA]
Listing certified through
2027-12-31
Current FDA listing
Yes

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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
ndc (product): 72511-143

Additional Listing Data#

Finished product
Yes
Brand name base
REPATHA
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
EVOLOCUMAB140 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
LKC0U3A8NJInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 6 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1665895Internal RxNorm lookup
1665900Internal RxNorm lookup
1665904Internal RxNorm lookup
1665906Internal RxNorm lookup
1801319Internal RxNorm lookup
1801322Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
cd61e902-166d-4aa6-9f3c-a18c1008d07eAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a21a21e5-f36d-4c1f-8918-def921b8f7e3Product name320250124
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
1ccb54cb-34f9-42d4-9813-bd91cebb9cadProduct name120150910
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125522Repathaevolocumab351(a)Rx2026-06-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1665895evolocumab 140 MG in 1 ML Auto-InjectorPSNcd61e902-166d-4aa6-9f3c-a18c1008d07e27
1665904evolocumab 140 MG in 1 ML Prefilled SyringePSNcd61e902-166d-4aa6-9f3c-a18c1008d07e27
1801319evolocumab 420 in 3.5 ML CartridgePSNcd61e902-166d-4aa6-9f3c-a18c1008d07e27
1665900Repatha 140 MG in 1 ML Auto-InjectorPSNcd61e902-166d-4aa6-9f3c-a18c1008d07e27
1665906Repatha 140 MG in 1 ML Prefilled SyringePSNcd61e902-166d-4aa6-9f3c-a18c1008d07e27
1801322Repatha 420 MG in 3.5 ML CartridgePSNcd61e902-166d-4aa6-9f3c-a18c1008d07e27
16659001 ML evolocumab 140 MG/ML Auto-Injector [Repatha]SBDcd61e902-166d-4aa6-9f3c-a18c1008d07e27
16659061 ML evolocumab 140 MG/ML Prefilled Syringe [Repatha]SBDcd61e902-166d-4aa6-9f3c-a18c1008d07e27
18013223.5 ML evolocumab 120 MG/ML Cartridge [Repatha]SBDcd61e902-166d-4aa6-9f3c-a18c1008d07e27
16658951 ML evolocumab 140 MG/ML Auto-InjectorSCDcd61e902-166d-4aa6-9f3c-a18c1008d07e27
16659041 ML evolocumab 140 MG/ML Prefilled SyringeSCDcd61e902-166d-4aa6-9f3c-a18c1008d07e27
18013193.5 ML evolocumab 120 MG/ML CartridgeSCDcd61e902-166d-4aa6-9f3c-a18c1008d07e27
16659001 ML Repatha 140 MG/ML Auto-InjectorSYcd61e902-166d-4aa6-9f3c-a18c1008d07e27
16659061 ML Repatha 140 MG/ML Prefilled SyringeSYcd61e902-166d-4aa6-9f3c-a18c1008d07e27
16659001 ML Repatha SureClick 140 MG/ML Auto-InjectorSYcd61e902-166d-4aa6-9f3c-a18c1008d07e27
18013223.5 ML Repatha 120 MG/ML CartridgeSYcd61e902-166d-4aa6-9f3c-a18c1008d07e27
1801319evolocumab 420 per 3.5 ML CartridgeSYcd61e902-166d-4aa6-9f3c-a18c1008d07e27
1801322Repatha 420 MG per 3.5 ML CartridgeSYcd61e902-166d-4aa6-9f3c-a18c1008d07e27

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleStatus
72511-143-01725110143011 SYRINGE in 1 CARTON (72511-143-01) / 1 mL in 1 SYRINGE1 syringe2026-07-130Current
72511-143-02725110143021 SYRINGE in 1 CARTON (72511-143-02) / 1 mL in 1 SYRINGE1 syringe2026-07-130Current
72511-143-96725110143961 SYRINGE in 1 CARTON (72511-143-96) / 1 mL in 1 SYRINGE1 syringe2026-07-131Current