FDA.reportPublic FDA data

AJOVY

Product NDC
51759-202
11-digit product format
517590202
Labeler code
51759
Product ID
51759-202_fc78e33c-331e-42e0-b780-3db6f5c108bd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
fremanezumab-vfrm
Dosage form
INJECTION
Route
SUBCUTANEOUS
Labeler
Teva Pharmaceuticals USA, Inc.
Application
BLA761089
Marketing category
BLA
Marketing start
2020-03-29
Substance
FREMANEZUMAB
Active strength
225 mg/1.5mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
AJOVY
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FREMANEZUMAB225 mg/1.5mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiPF8K38CG54
Rxcui2056695, 2056700, 2287903, 2287905

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
91f08e56-3cf0-4c4b-8aff-313a37779363Product name120181226
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51759-202-10AJOVY1 in 1 CARTONINJECTION123
51759-202-10AJOVY1.5 mL in 1 CONTAINERINJECTION1.523
51759-202-11AJOVY1 in 1 CARTONINJECTION123
51759-202-11AJOVY1.5 mL in 1 CONTAINERINJECTION1.523
51759-202-22AJOVY1.5 mL in 1 CONTAINERINJECTION1.523
51759-202-22AJOVY3 in 1 CARTONINJECTION323

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51759-202-10ML - Milliliter51759-202f7309246-cc1b-4e9a-946b-9ca215554a3b12020-04-20
51759-202-22ML - Milliliter51759-202411cbfda-8772-4081-89b0-94588be25fa712021-02-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51759-202AJOVY (FREMANEZUMAB-VFRM) INJECTION [TEVA PHARMACEUTICALS USA, INC.]21Current NDC, Legacy NDC, 6 package rows20250328_98e344ea-5916-4947-b6f2-4a76ccc04b6b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2287905AJOVY 225 MG in 1.5 mL Auto-InjectorPSN98e344ea-5916-4947-b6f2-4a76ccc04b6b23
2056700AJOVY 225 MG in 1.5 mL Prefilled SyringePSN98e344ea-5916-4947-b6f2-4a76ccc04b6b23
2287903fremanezumab-vfrm 225 MG in 1.5 mL Auto-InjectorPSN98e344ea-5916-4947-b6f2-4a76ccc04b6b23
2056695fremanezumab-vfrm 225 MG in 1.5 mL Prefilled SyringePSN98e344ea-5916-4947-b6f2-4a76ccc04b6b23
22879051.5 ML fremanezumab-vfrm 150 MG/ML Auto-Injector [Ajovy]SBD98e344ea-5916-4947-b6f2-4a76ccc04b6b23
20567001.5 ML fremanezumab-vfrm 150 MG/ML Prefilled Syringe [Ajovy]SBD98e344ea-5916-4947-b6f2-4a76ccc04b6b23
22879031.5 ML fremanezumab-vfrm 150 MG/ML Auto-InjectorSCD98e344ea-5916-4947-b6f2-4a76ccc04b6b23
20566951.5 ML fremanezumab-vfrm 150 MG/ML Prefilled SyringeSCD98e344ea-5916-4947-b6f2-4a76ccc04b6b23
22879051.5 ML Ajovy 150 MG/ML Auto-InjectorSY98e344ea-5916-4947-b6f2-4a76ccc04b6b23
20567001.5 ML Ajovy 150 MG/ML Prefilled SyringeSY98e344ea-5916-4947-b6f2-4a76ccc04b6b23
2287905Ajovy 225 MG per 1.5 ML Auto-InjectorSY98e344ea-5916-4947-b6f2-4a76ccc04b6b23
2056700Ajovy 225 MG per 1.5 ML Prefilled SyringeSY98e344ea-5916-4947-b6f2-4a76ccc04b6b23
2287903fremanezumab-vfrm 225 MG per 1.5 mL Auto-InjectorSY98e344ea-5916-4947-b6f2-4a76ccc04b6b23
2056695fremanezumab-vfrm 225 MG per 1.5 ML Prefilled SyringeSY98e344ea-5916-4947-b6f2-4a76ccc04b6b23

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51759-202-10517590202101 CONTAINER in 1 CARTON (51759-202-10) / 1.5 mL in 1 CONTAINER1 container2020-03-290000-00-00NoNoCurrent
51759-202-11517590202111 CONTAINER in 1 CARTON (51759-202-11) / 1.5 mL in 1 CONTAINER1 container2020-03-290000-00-00YesNoCurrent
51759-202-22517590202223 CONTAINER in 1 CARTON (51759-202-22) / 1.5 mL in 1 CONTAINER3 container2020-08-310000-00-00NoNoCurrent