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
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FREMANEZUMAB225 mg/1.5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
PF8K38CG54Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2056695Internal RxNorm lookup
2056700Internal RxNorm lookup
2287903Internal RxNorm lookup
2287905Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
98e344ea-5916-4947-b6f2-4a76ccc04b6bAvailable on FDA.report

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

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
AJOVYFREMANEZUMAB-VFRMTeva Pharmaceuticals USA, Inc.98e344ea-5916-4947-b6f2-4a76ccc04b6b2026-06-05Warnings, Adverse reactionsExact identifier
application number: BLA761089
ndc (product): 51759-202

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761089Ajovyfremanezumab-vfrm351(a)Rx2026-06-01

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