AJOVY

Product NDC: 51759-204
11-digit product format: 517590204
Labeler code: 51759
Product ID: 51759-204_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: 2018-09-15
Substance: FREMANEZUMAB
Active strength: 225 mg/1.5mL
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	51759-204	51759-204-11	D	Discontinued by firm		2026-08-03

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

Additional Listing Data#

Finished product: Yes
Brand name base: AJOVY
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
FREMANEZUMAB	225 mg/1.5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
PF8K38CG54	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
98e344ea-5916-4947-b6f2-4a76ccc04b6b	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
91f08e56-3cf0-4c4b-8aff-313a37779363	Product name	1	20181226
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
51759-204-10	AJOVY	1.5 mL in 1 SYRINGE, GLASS	INJECTION	1.5	23
51759-204-10	AJOVY	1 in 1 CARTON	INJECTION	1	23
51759-204-11	AJOVY	1.5 mL in 1 SYRINGE, GLASS	INJECTION	1.5	23
51759-204-11	AJOVY	1 in 1 CARTON	INJECTION	1	23

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
51759-204-10	ML - Milliliter	51759-204	a5af4b64-86de-45fe-b50b-3f20e524a831	1	2018-10-11
51759-204-11	ML - Milliliter	51759-204	671e39bc-bbfb-4d4b-95a1-3845d4764f05	1	2019-01-24

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51759-204	AJOVY (FREMANEZUMAB-VFRM) INJECTION [TEVA PHARMACEUTICALS USA, INC.]	21	Current NDC, Legacy NDC, 4 package rows	20250328_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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
AJOVY	FREMANEZUMAB-VFRM	Teva Pharmaceuticals USA, Inc.	98e344ea-5916-4947-b6f2-4a76ccc04b6b	2026-06-05	Warnings, Adverse reactions	Exact identifier application number: BLA761089 ndc (product): 51759-204

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLA	Proprietary name	Proper name	License type	Status	Latest source
761089	Ajovy	fremanezumab-vfrm	351(a)	Rx	2026-06-01

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
PF8K38CG54	FREMANEZUMAB	1655501-53-3	FREMANEZUMAB

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2287905	AJOVY 225 MG in 1.5 mL Auto-Injector	PSN	98e344ea-5916-4947-b6f2-4a76ccc04b6b	23
2056700	AJOVY 225 MG in 1.5 mL Prefilled Syringe	PSN	98e344ea-5916-4947-b6f2-4a76ccc04b6b	23
2287903	fremanezumab-vfrm 225 MG in 1.5 mL Auto-Injector	PSN	98e344ea-5916-4947-b6f2-4a76ccc04b6b	23
2056695	fremanezumab-vfrm 225 MG in 1.5 mL Prefilled Syringe	PSN	98e344ea-5916-4947-b6f2-4a76ccc04b6b	23
2287905	1.5 ML fremanezumab-vfrm 150 MG/ML Auto-Injector [Ajovy]	SBD	98e344ea-5916-4947-b6f2-4a76ccc04b6b	23
2056700	1.5 ML fremanezumab-vfrm 150 MG/ML Prefilled Syringe [Ajovy]	SBD	98e344ea-5916-4947-b6f2-4a76ccc04b6b	23
2287903	1.5 ML fremanezumab-vfrm 150 MG/ML Auto-Injector	SCD	98e344ea-5916-4947-b6f2-4a76ccc04b6b	23
2056695	1.5 ML fremanezumab-vfrm 150 MG/ML Prefilled Syringe	SCD	98e344ea-5916-4947-b6f2-4a76ccc04b6b	23
2287905	1.5 ML Ajovy 150 MG/ML Auto-Injector	SY	98e344ea-5916-4947-b6f2-4a76ccc04b6b	23
2056700	1.5 ML Ajovy 150 MG/ML Prefilled Syringe	SY	98e344ea-5916-4947-b6f2-4a76ccc04b6b	23
2287905	Ajovy 225 MG per 1.5 ML Auto-Injector	SY	98e344ea-5916-4947-b6f2-4a76ccc04b6b	23
2056700	Ajovy 225 MG per 1.5 ML Prefilled Syringe	SY	98e344ea-5916-4947-b6f2-4a76ccc04b6b	23
2287903	fremanezumab-vfrm 225 MG per 1.5 mL Auto-Injector	SY	98e344ea-5916-4947-b6f2-4a76ccc04b6b	23
2056695	fremanezumab-vfrm 225 MG per 1.5 ML Prefilled Syringe	SY	98e344ea-5916-4947-b6f2-4a76ccc04b6b	23

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
51759-204-10	51759020410	1 SYRINGE, GLASS in 1 CARTON (51759-204-10) / 1.5 mL in 1 SYRINGE, GLASS	2018-09-15	0000-00-00	No	No	Current
51759-204-11	51759020411	1 SYRINGE, GLASS in 1 CARTON (51759-204-11) > 1.5 mL in 1 SYRINGE, GLASS	2018-09-15	0000-00-00	Yes	No	Current