FDA.reportPublic FDA data

REPATHA

Product NDC
72511-770
11-digit product format
725110770
Labeler code
72511
Product ID
72511-770_a3b9ef22-b46e-4809-a9a9-fea2729bb703
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Evolocumab
Dosage form
KIT
Labeler
Amgen USA Inc.
Application
BLA125522
Marketing category
BLA
Marketing start
2018-10-09
Marketing end
0000-00-00
Active strength
0
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

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
72511-770-01REPATHA1 in 1 CARTONKIT127
72511-770-91REPATHA1 in 1 CARTONKIT127

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72511-770-01ML - Milliliter72511-770e16d7c94-60c2-4035-bf1b-d0f8ea482de712019-01-24

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72511-770REPATHA (EVOLOCUMAB) INJECTION, SOLUTION REPATHA (EVOLOCUMAB) KIT [AMGEN USA INC.]24Legacy NDC, 2 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
72511-770-01725110770011 KIT in 1 CARTON (72511-770-01) * 1 CARTRIDGE in 1 TRAY > 3.5 mL in 1 CARTRIDGE1 kit2018-10-090000-00-00NoNoCurrent
72511-770-91725110770911 in 1 CARTONHistorical