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 Identifiers#

Field, Values table
FieldValues
UniiLKC0U3A8NJ
Rxcui1665895, 1665900, 1665904, 1665906, 1801319, 1801322

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

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