FDA.reportPublic FDA data

AIMOVIG

Product NDC
55513-843
11-digit product format
555130843
Labeler code
55513
Product ID
55513-843_0e9f4d69-138c-4098-93b3-527229f49acd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
erenumab-aooe
Dosage form
INJECTION, SOLUTION
Route
SUBCUTANEOUS
Labeler
Amgen Inc
Application
BLA761077
Marketing category
BLA
Marketing start
2019-03-15
Substance
ERENUMAB
Active strength
140 mg/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ERENUMAB140 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiI5I8VB78VT
Rxcui2045627, 2045632, 2045636, 2045638, 2056669, 2056670, 2056680, 2056681, 2120193, 2120195, 2120198, 2120199

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
55513-843-00AIMOVIG1 mL in 1 SYRINGEINJECTION, SOLUTION124
55513-843-00AIMOVIG1 in 1 CARTONINJECTION, SOLUTION124
55513-843-01AIMOVIG1 mL in 1 SYRINGEINJECTION, SOLUTION124
55513-843-01AIMOVIG1 in 1 CARTONINJECTION, SOLUTION124

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55513-843-01ML - Milliliter55513-843d2fa0b47-a02c-488d-9860-2ec58c71ffc512019-04-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55513-843AIMOVIG (ERENUMAB-AOOE) INJECTION AIMOVIG (ERENUMAB-AOOE) INJECTION, SOLUTION [AMGEN INC]23Current NDC, Legacy NDC, 4 package rows20250406_b998ed05-94b0-47fd-b28f-cddd1e128fd8.zip

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
55513-843-00555130843001 SYRINGE in 1 CARTON (55513-843-00) / 1 mL in 1 SYRINGE1 syringe2019-03-150000-00-00YesNoCurrent
55513-843-01555130843011 SYRINGE in 1 CARTON (55513-843-01) / 1 mL in 1 SYRINGE1 syringe2019-03-150000-00-00NoNoCurrent