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Fetzima

Levomilnacipran Hydrochloride · Capsule, Extended Release

Prescription NDA TE AB RLD
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
Fetzima
Generic name
Levomilnacipran Hydrochloride
Dosage form
Capsule, Extended Release
Route
Oral
Marketing category
NDA · NDA
Labeler
Allergan, Inc.
Product type
Human Prescription Drug
DEA schedule
Not scheduled
Active ingredients
4
NDC product codes
4
Packages
8
Data completeness
54% of corroborating sources present

Active ingredients

Source: NDC Directory
Active ingredients and strengths as listed in the NDC Directory.
Ingredient Strength RxCUI Monograph
Levomilnacipran Hydrochloride 120 mg/1 1433217 —
Levomilnacipran Hydrochloride 20 mg/1 1433217 —
Levomilnacipran Hydrochloride 40 mg/1 1433217 —
Levomilnacipran Hydrochloride 80 mg/1 1433217 —

Forms, strengths and routes

Source: NDC Directory
Dosage form
Capsule, Extended Release
Route of administration
Oral
Presentations
12

Pharmacologic classes are listed in the class section below.

Pharmacologic class

Source: NDC Directory
Established pharmacologic classes (EPC), mechanisms of action (MoA), chemical structures (CS) and physiologic effects (PE).
Class Type Browse
Norepinephrine Uptake Inhibitors [MoA] MoA All 44 members
Serotonin Uptake Inhibitors [MoA] MoA All 73 members
Serotonin and Norepinephrine Reuptake Inhibitor [EPC] EPC All 26 members

Regulatory status

Source: Drugs@FDANDC Directory
Application number
204168
Application type
NDA · New Drug Application
Approval date
July 25, 2013
Sponsor
ABBVIE
Products on application
4
Submissions recorded
11
Products approved under application 204168.
Product Trade name Form Strength Ingredient Status TE Flags
204168-001 FETZIMA CAPSULE, EXTENDED RELEASE LEVOMILNACIPRAN HYDROCHLORIDE Prescription AB RLD
204168-002 FETZIMA CAPSULE, EXTENDED RELEASE LEVOMILNACIPRAN HYDROCHLORIDE Prescription AB RLD
204168-003 FETZIMA CAPSULE, EXTENDED RELEASE LEVOMILNACIPRAN HYDROCHLORIDE Prescription AB RLD
204168-004 FETZIMA CAPSULE, EXTENDED RELEASE LEVOMILNACIPRAN HYDROCHLORIDE Prescription AB RLD RS

Therapeutic equivalence

Source: Orange Book
TE code
AB
Reference Listed Drug
Yes
Reference Standard
Yes

What this rating means: Therapeutically equivalent — bioequivalence demonstrated by in vivo or in vitro testing

Codes beginning with “A” indicate products the FDA considers therapeutically equivalent. Codes beginning with “B” indicate bioequivalence has not been established. See methodology.

Patents and exclusivity

Source: Orange Book
Patent listings submitted under 21 U.S.C. 355(b)(1) and (c)(2).
Patent Expires Product Substance Use code Submitted
RE43879 January 11, 2026 001 No U-839 August 15, 2013
RE43879 January 11, 2026 002 No U-839 August 15, 2013
RE43879 January 11, 2026 003 No U-839 August 15, 2013
RE43879 January 11, 2026 004 No U-839 August 15, 2013
8481598 March 2, 2031 001 No U-839 August 15, 2013
8481598 March 2, 2031 002 No U-839 August 15, 2013
8481598 March 2, 2031 003 No U-839 August 15, 2013
8481598 March 2, 2031 004 No U-839 August 15, 2013
8865937 May 23, 2032 001 Yes November 20, 2014
8865937 May 23, 2032 002 Yes November 20, 2014
8865937 May 23, 2032 003 Yes November 20, 2014
8865937 May 23, 2032 004 Yes November 20, 2014
Regulatory exclusivity periods.
Code Expires Product
M-304 March 24, 2026 001
M-304 March 24, 2026 002
M-304 March 24, 2026 003
M-304 March 24, 2026 004

Approval history

Source: Drugs@FDA
Most recent submissions on application 204168.
Type No. Action Status Date Review
Supplement 12 Labeling Approved April 19, 2024 Standard
Supplement 11 Labeling Approved August 18, 2023 Standard
Supplement 10 Efficacy Approved March 24, 2023 Standard
Supplement 7 Labeling Approved September 20, 2021 901 Required
Supplement 6 Efficacy Approved October 7, 2019 Standard
Supplement 5 Labeling Approved December 19, 2017 901 Required
Supplement 4 Labeling Approved January 4, 2017 901 Required
Supplement 3 Manufacturing (CMC) Approved June 5, 2015 Standard
Supplement 2 Labeling Approved July 18, 2014 901 Required
Supplement 1 Labeling Approved May 23, 2014 Standard
Original application 1 Type 2 - New Active Ingredient Approved July 25, 2013 Standard

Review documents

  • 0 · Supplement · April 25, 2024
  • 0 · Supplement · April 24, 2024
  • 0 · Supplement · April 22, 2024
  • 0 · Supplement · August 22, 2023
  • 0 · Supplement · August 21, 2023
  • 0 · Supplement · March 28, 2023
  • 0 · Supplement · March 27, 2023
  • 0 · Supplement · September 24, 2021
  • 0 · Supplement · September 22, 2021
  • 0 · Supplement · November 26, 2019
  • 0 · Supplement · October 8, 2019
  • 0 · Supplement · December 27, 2017
  • 0 · Supplement · December 21, 2017
  • 0 · Supplement · January 10, 2017
  • 0 · Supplement · January 6, 2017
  • 0 · Supplement · August 5, 2014
  • 0 · Supplement · July 23, 2014
  • 0 · Supplement · July 23, 2014
  • 0 · Supplement · May 27, 2014
  • 0 · Original application · March 14, 2014
  • 0 · Original application · March 14, 2014
  • 0 · Original application · July 30, 2013
  • 0 · Original application · July 29, 2013

Adverse event reports

Source: openFDA FAERS
1,905
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: LEVOMILNACIPRAN HYDROCHLORIDE. 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
0456-2212-30 0456-2212 Allergan, Inc. 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0456-2212-30) July 25, 2013
0456-2212-90 0456-2212 Allergan, Inc. 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0456-2212-90) July 25, 2013
0456-2220-07 0456-2220 Allergan, Inc. 40 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0456-2220-07) July 25, 2013
0456-2220-30 0456-2220 Allergan, Inc. 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0456-2220-30) July 25, 2013
0456-2240-30 0456-2240 Allergan, Inc. 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0456-2240-30) July 25, 2013
0456-2240-90 0456-2240 Allergan, Inc. 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0456-2240-90) July 25, 2013
0456-2280-30 0456-2280 Allergan, Inc. 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0456-2280-30) July 25, 2013
0456-2280-90 0456-2280 Allergan, Inc. 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0456-2280-90) July 25, 2013
0456-2212 0456-2212 Allergan, Inc. — July 25, 2013
0456-2220 0456-2220 Allergan, Inc. — July 25, 2013
0456-2240 0456-2240 Allergan, Inc. — July 25, 2013
0456-2280 0456-2280 Allergan, Inc. — July 25, 2013

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
Orange Book FDA Therapeutic equivalence codes, reference drug flags, patents, exclusivity
FAERS FDA Adverse event report counts

Generated September 25, 2026 · 12 sections on this page.