FDA.reportPublic FDA data

REPATHA

Product NDC
72511-760
11-digit product format
725110760
Labeler code
72511
Product ID
72511-760_d9a0c476-16cf-46ae-8525-a89da9d76fc4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Evolocumab
Dosage form
INJECTION, SOLUTION
Route
SUBCUTANEOUS
Labeler
Amgen USA Inc.
Application
BLA125522
Marketing category
BLA
Marketing start
2018-10-09
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
2027-12-31
Current FDA listing
Yes

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72511-760-01REPATHA1 mL in 1 SYRINGEINJECTION, SOLUTION127
72511-760-02REPATHA2 in 1 CARTONINJECTION, SOLUTION227
72511-760-91REPATHA1 mL in 1 SYRINGEINJECTION, SOLUTION127
72511-760-91REPATHA1 in 1 CARTONINJECTION, SOLUTION127

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72511-760-01ML - Milliliter72511-76020e504f2-5201-499c-81d2-a1c4257b23a212018-11-06
72511-760-02ML - Milliliter72511-760bd808fff-59cf-49d3-b16d-fafd25199d2612018-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72511-760REPATHA (EVOLOCUMAB) INJECTION, SOLUTION REPATHA (EVOLOCUMAB) KIT [AMGEN USA INC.]24Current NDC, Legacy NDC, 4 package rows20250524_cd61e902-166d-4aa6-9f3c-a18c1008d07e.zip

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
ndc (product): 72511-760

Purple Book Biologic Products#

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

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 startMarketing endSampleExclude flagStatus
72511-760-01725110760011 mL in 1 SYRINGE1 mlHistorical
72511-760-02725110760022 SYRINGE in 1 CARTON (72511-760-02) / 1 mL in 1 SYRINGE (72511-760-01) 2 syringe2018-10-090000-00-00NoNoCurrent
72511-760-91725110760911 SYRINGE in 1 CARTON (72511-760-91) / 1 mL in 1 SYRINGE1 syringe2022-06-010000-00-00YesNoCurrent