FDA.reportPublic FDA data

AIMOVIG

Product NDC
55513-841
11-digit product format
555130841
Labeler code
55513
Product ID
55513-841_0e9f4d69-138c-4098-93b3-527229f49acd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
erenumab-aooe
Dosage form
INJECTION
Route
SUBCUTANEOUS
Labeler
Amgen Inc
Application
BLA761077
Marketing category
BLA
Marketing start
2018-05-22
Substance
ERENUMAB
Active strength
70 mg/mL
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
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage55513-84155513-841-02DDiscontinued by firm2026-08-11

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 dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ERENUMAB70 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
I5I8VB78VTInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 12 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2045627Internal RxNorm lookup
2045632Internal RxNorm lookup
2045636Internal RxNorm lookup
2045638Internal RxNorm lookup
2056669Internal RxNorm lookup
2056670Internal RxNorm lookup
2056680Internal RxNorm lookup
2056681Internal RxNorm lookup
2120193Internal RxNorm lookup
2120195Internal RxNorm lookup
2120198Internal RxNorm lookup
2120199Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
b998ed05-94b0-47fd-b28f-cddd1e128fd8Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a21a21e5-f36d-4c1f-8918-def921b8f7e3Product name320250124
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
c1c63e2c-4d46-4bf5-a2ec-85cf6537d4a5Product name220190619
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
55513-841-00AIMOVIG1 mL in 1 SYRINGE, GLASSINJECTION124
55513-841-00AIMOVIG2 in 1 CARTONINJECTION224
55513-841-01AIMOVIG1 mL in 1 SYRINGE, GLASSINJECTION124
55513-841-01AIMOVIG1 in 1 CARTONINJECTION124
55513-841-02AIMOVIG1 mL in 1 SYRINGE, GLASSINJECTION124
55513-841-02AIMOVIG2 in 1 CARTONINJECTION224

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55513-841-01ML - Milliliter55513-841d82fb3ff-1620-4159-a101-738db9b97d6312018-06-11
55513-841-02ML - Milliliter55513-841d4c4a846-ddd2-4eff-a589-4eac9eaea96112018-06-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55513-841AIMOVIG (ERENUMAB-AOOE) INJECTION AIMOVIG (ERENUMAB-AOOE) INJECTION, SOLUTION [AMGEN INC]23Current NDC, Legacy NDC, 6 package rows20250406_b998ed05-94b0-47fd-b28f-cddd1e128fd8.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
AIMOVIGERENUMAB-AOOEAmgen, Incb998ed05-94b0-47fd-b28f-cddd1e128fd82026-07-14Warnings, Adverse reactionsExact identifier
application number: BLA761077
ndc (product): 55513-841

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761077Aimovigerenumab-aooe351(a)Rx2026-07-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2056670{2 (1 ML erenumab-aooe 70 MG/ML Auto-Injector [Aimovig]) } Pack [Aimovig Autoinjector (140 MG Dose)]BPCKb998ed05-94b0-47fd-b28f-cddd1e128fd824
2056681{2 (1 ML erenumab-aooe 70 MG/ML Prefilled Syringe [Aimovig]) } Pack [Aimovig Prefilled Syringe (140 MG Dose)]BPCKb998ed05-94b0-47fd-b28f-cddd1e128fd824
2056669{2 (1 ML erenumab-aooe 70 MG/ML Auto-Injector) } PackGPCKb998ed05-94b0-47fd-b28f-cddd1e128fd824
2056680{2 (1 ML erenumab-aooe 70 MG/ML Prefilled Syringe) } PackGPCKb998ed05-94b0-47fd-b28f-cddd1e128fd824
2120195Aimovig 140 MG in 1 mL Auto-InjectorPSNb998ed05-94b0-47fd-b28f-cddd1e128fd824
2120199Aimovig 140 MG in 1 mL Prefilled SyringePSNb998ed05-94b0-47fd-b28f-cddd1e128fd824
2045638Aimovig 70 MG in 1 mL Auto-InjectorPSNb998ed05-94b0-47fd-b28f-cddd1e128fd824
2045632Aimovig 70 MG in 1 mL Prefilled SyringePSNb998ed05-94b0-47fd-b28f-cddd1e128fd824
2056670Aimovig Autoinjector 2-Pack (140 MG Dose)PSNb998ed05-94b0-47fd-b28f-cddd1e128fd824
2056681Aimovig Prefilled Syringe 2-Pack (140 MG Dose)PSNb998ed05-94b0-47fd-b28f-cddd1e128fd824
2120193erenumab-aooe 140 MG in 1 mL Auto-InjectorPSNb998ed05-94b0-47fd-b28f-cddd1e128fd824
2120198erenumab-aooe 140 MG/ML in 1 mL Prefilled SyringePSNb998ed05-94b0-47fd-b28f-cddd1e128fd824
2045636erenumab-aooe 70 MG in 1 mL Auto-InjectorPSNb998ed05-94b0-47fd-b28f-cddd1e128fd824
2056669erenumab-aooe 70 MG in 1 ML Auto-Injector 2-Pack (140 MG Dose)PSNb998ed05-94b0-47fd-b28f-cddd1e128fd824
2045627erenumab-aooe 70 MG in 1 mL Prefilled SyringePSNb998ed05-94b0-47fd-b28f-cddd1e128fd824
2056680erenumab-aooe 70 MG in 1 ML Prefilled Syringe 2-Pack (140 MG Dose)PSNb998ed05-94b0-47fd-b28f-cddd1e128fd824
21201951 ML erenumab-aooe 140 MG/ML Auto-Injector [Aimovig]SBDb998ed05-94b0-47fd-b28f-cddd1e128fd824
21201991 ML erenumab-aooe 140 MG/ML Prefilled Syringe [Aimovig]SBDb998ed05-94b0-47fd-b28f-cddd1e128fd824
20456381 ML erenumab-aooe 70 MG/ML Auto-Injector [Aimovig]SBDb998ed05-94b0-47fd-b28f-cddd1e128fd824
20456321 ML erenumab-aooe 70 MG/ML Prefilled Syringe [Aimovig]SBDb998ed05-94b0-47fd-b28f-cddd1e128fd824
21201931 ML erenumab-aooe 140 MG/ML Auto-InjectorSCDb998ed05-94b0-47fd-b28f-cddd1e128fd824
21201981 ML erenumab-aooe 140 MG/ML Prefilled SyringeSCDb998ed05-94b0-47fd-b28f-cddd1e128fd824
20456361 ML erenumab-aooe 70 MG/ML Auto-InjectorSCDb998ed05-94b0-47fd-b28f-cddd1e128fd824
20456271 ML erenumab-aooe 70 MG/ML Prefilled SyringeSCDb998ed05-94b0-47fd-b28f-cddd1e128fd824
21201951 ML Aimovig 140 MG/ML Auto-InjectorSYb998ed05-94b0-47fd-b28f-cddd1e128fd824
21201991 ML Aimovig 140 MG/ML Prefilled SyringeSYb998ed05-94b0-47fd-b28f-cddd1e128fd824
20456381 ML Aimovig 70 MG/ML Auto-InjectorSYb998ed05-94b0-47fd-b28f-cddd1e128fd824
20456321 ML Aimovig 70 MG/ML Prefilled SyringeSYb998ed05-94b0-47fd-b28f-cddd1e128fd824
2120195Aimovig 140 MG per 1 mL Auto-InjectorSYb998ed05-94b0-47fd-b28f-cddd1e128fd824
2120199Aimovig 140 MG per 1 mL Prefilled SyringeSYb998ed05-94b0-47fd-b28f-cddd1e128fd824
2045638Aimovig 70 MG per 1 ML Auto-InjectorSYb998ed05-94b0-47fd-b28f-cddd1e128fd824
2045632Aimovig 70 MG per 1 ML Prefilled SyringeSYb998ed05-94b0-47fd-b28f-cddd1e128fd824
2056670Aimovig Autoinjector 2-Pack (140 MG Dose)SYb998ed05-94b0-47fd-b28f-cddd1e128fd824
2056681Aimovig Prefilled Syringe 2-Pack (140 MG Dose)SYb998ed05-94b0-47fd-b28f-cddd1e128fd824
2120193erenumab-aooe 140 MG per 1 mL Auto-InjectorSYb998ed05-94b0-47fd-b28f-cddd1e128fd824
2120198erenumab-aooe 140 MG/ML per 1 mL Prefilled SyringeSYb998ed05-94b0-47fd-b28f-cddd1e128fd824
2045636erenumab-aooe 70 MG per 1 ML Auto-InjectorSYb998ed05-94b0-47fd-b28f-cddd1e128fd824
2056669erenumab-aooe 70 MG per 1 ML Auto-Injector 2-Pack (140 MG Dose)SYb998ed05-94b0-47fd-b28f-cddd1e128fd824
2045627erenumab-aooe 70 MG per 1 ML Prefilled SyringeSYb998ed05-94b0-47fd-b28f-cddd1e128fd824
2056680erenumab-aooe 70 MG per 1 ML Prefilled Syringe 2-Pack (140 MG Dose)SYb998ed05-94b0-47fd-b28f-cddd1e128fd824

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55513-841-00555130841002 SYRINGE, GLASS in 1 CARTON (55513-841-00) / 1 mL in 1 SYRINGE, GLASS2018-05-22YesNoCurrent
55513-841-01555130841011 SYRINGE, GLASS in 1 CARTON (55513-841-01) / 1 mL in 1 SYRINGE, GLASS2018-05-220000-00-00NoNoCurrent
55513-841-02555130841021 mL in 1 SYRINGE, GLASS1 mlHistorical