OpenRx Open Medications Explorer
© 2026 OpenRx · public-domain U.S. government data
On this page

AIMOVIG

erenumab-aooe · Injection, Solution

Prescription Biologic BLA
Informational index, not medical advice. Content is reproduced from public FDA and NLM data. Always confirm against the manufacturer's current prescribing information. Report adverse events to FDA MedWatch.

Overview

Brand name
AIMOVIG
Generic name
erenumab-aooe
Dosage form
Injection, Solution
Route
Subcutaneous
Marketing category
BLA · BLA
Labeler
Amgen, Inc
Product type
Human Prescription Drug
DEA schedule
Not scheduled
Active ingredients
1
NDC product codes
2
Packages
3
Data completeness
52% of corroborating sources present

Active ingredients

Source: NDC Directory
Active ingredients and strengths as listed in the NDC Directory.
Ingredient Strength RxCUI Monograph
Erenumab 140 mg/mL 2045627 View

Forms, strengths and routes

Source: NDC Directory
Dosage form
Injection, Solution
Route of administration
Subcutaneous
Presentations
5

Regulatory status

Source: Drugs@FDANDC Directory
Application number
761077
Application type
BLA · Biologics License Application
Approval date
May 17, 2018
Sponsor
AMGEN INC
Products on application
1
Submissions recorded
14
Products approved under application 761077.
Product Trade name Form Strength Ingredient Status TE Flags
761077-001 AIMOVIG INJECTABLE ERENUMAB-AOOE Prescription —

Approval history

Source: Drugs@FDA
Most recent submissions on application 761077.
Type No. Action Status Date Review
Supplement 25 Labeling Approved June 19, 2025 Standard
Supplement 26 Labeling Approved March 21, 2025 Standard
Supplement 22 Labeling Approved August 6, 2024 Standard
Supplement 15 Efficacy Approved October 3, 2022 Standard
Supplement 17 Labeling Approved September 22, 2022 Standard
Supplement 16 Labeling Approved August 15, 2022 Standard
Supplement 14 Manufacturing (CMC) Approved March 4, 2022 N/A
Supplement 11 Labeling Approved May 11, 2021 Standard
Supplement 9 Labeling Approved February 3, 2021 Standard
Supplement 7 Labeling Approved April 30, 2020 901 Required
Supplement 4 Labeling Approved February 15, 2020 Standard
Supplement 3 Labeling Approved October 4, 2019 Standard
Supplement 1 Efficacy Approved March 11, 2019 Standard
Original application 1 Type 1 - New Molecular Entity Approved May 17, 2018 Standard

Review documents

  • 0 · Supplement · June 20, 2025
  • 0 · Supplement · June 20, 2025
  • 0 · Supplement · March 25, 2025
  • 0 · Supplement · March 24, 2025
  • 0 · Supplement · August 8, 2024
  • 0 · Supplement · August 8, 2024
  • 0 · Supplement · October 7, 2022
  • 0 · Supplement · October 4, 2022
  • 0 · Supplement · September 23, 2022
  • 0 · Supplement · September 23, 2022
  • 0 · Supplement · August 16, 2022
  • 0 · Supplement · March 14, 2022
  • 0 · Supplement · May 12, 2021
  • 0 · Supplement · May 12, 2021
  • 0 · Supplement · February 5, 2021
  • 0 · Supplement · February 4, 2021
  • 0 · Supplement · May 1, 2020
  • 0 · Supplement · May 1, 2020
  • 0 · Supplement · February 20, 2020
  • 0 · Supplement · February 19, 2020
  • 0 · Supplement · October 8, 2019
  • 0 · Supplement · October 7, 2019
  • 0 · Supplement · March 12, 2019
  • 0 · Supplement · March 12, 2019
  • 0 · Original application · June 14, 2018
  • 0 · Original application · May 18, 2018
  • 0 · Original application · May 18, 2018

Adverse event reports

Source: openFDA FAERS
54,778
FAERS reports mentioning this drug
as of 2026-09-25T03:42:24+00:00
A report count is not a risk measure. FAERS accepts voluntary and mandatory reports without establishing causation, and reporting is influenced by how widely a drug is used, how long it has been marketed, and media attention. FDA states that reports “do not prove that the drug caused the event”. Compare rates, not totals.

Attributed to this product's most-reported active ingredient: ERENUMAB. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.

Packaging and NDCs

Source: NDC Directory
Every National Drug Code package associated with this medication. The NDC is the identifier used for dispensing, billing and pharmacovigilance in the United States.
Package NDC Product NDC Labeler Description Marketing start
55513-842-01 55513-842 Amgen, Inc 1 SYRINGE in 1 CARTON (55513-842-01) / 1 mL in 1 SYRINGE March 15, 2019
55513-843-00 55513-843 Amgen, Inc 1 SYRINGE in 1 CARTON (55513-843-00) / 1 mL in 1 SYRINGE March 15, 2019
55513-843-01 55513-843 Amgen, Inc 1 SYRINGE in 1 CARTON (55513-843-01) / 1 mL in 1 SYRINGE March 15, 2019
55513-842 55513-842 Amgen, Inc — March 15, 2019
55513-843 55513-843 Amgen, Inc — March 15, 2019

Sources for this page

Every dataset that contributed a fact to this page.
Dataset Agency Used for
NDC Directory FDA Identity, ingredients, strengths, forms, routes, labelers, packages
Drugs@FDA FDA Application, sponsor, submissions, review documents, marketing status
FAERS FDA Adverse event report counts
Purple Book FDA Biologic licence classification

Generated September 25, 2026 · 9 sections on this page.