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Milnacipran HCl

Prescription ANDA TE AB
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
Milnacipran HCl
Generic name
Milnacipran HCl
Dosage form
Tablet
Route
Oral
Marketing category
ANDA · ANDA
Labeler
Amneal Pharmaceuticals LLC
Product type
Human Prescription Drug
DEA schedule
Not scheduled
Active ingredients
4
NDC product codes
4
Packages
6
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
Milnacipran Hydrochloride 100 mg/1 833135 View
Milnacipran Hydrochloride 12.5 mg/1 833135 View
Milnacipran Hydrochloride 25 mg/1 833135 View
Milnacipran Hydrochloride 50 mg/1 833135 View

Forms, strengths and routes

Source: NDC Directory
Dosage form
Tablet
Route of administration
Oral
Presentations
10

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
205081
Application type
ANDA · Abbreviated New Drug Application
Approval date
April 22, 2016
Sponsor
AMNEAL PHARMS
Products on application
4
Submissions recorded
8
Products approved under application 205081.
Product Trade name Form Strength Ingredient Status TE Flags
205081-001 MILNACIPRAN HYDROCHLORIDE TABLET MILNACIPRAN HYDROCHLORIDE Prescription AB
205081-002 MILNACIPRAN HYDROCHLORIDE TABLET MILNACIPRAN HYDROCHLORIDE Prescription AB
205081-003 MILNACIPRAN HYDROCHLORIDE TABLET MILNACIPRAN HYDROCHLORIDE Prescription AB
205081-004 MILNACIPRAN HYDROCHLORIDE TABLET MILNACIPRAN HYDROCHLORIDE Prescription AB

Therapeutic equivalence

Source: Orange Book
TE code
AB
Reference Listed Drug
No
Reference Standard
No

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.

Approval history

Source: Drugs@FDA
Most recent submissions on application 205081.
Type No. Action Status Date Review
Supplement 10 Labeling Approved April 14, 2026 Standard
Supplement 8 Labeling Approved March 13, 2025 Standard
Supplement 7 Labeling Approved March 13, 2025 Standard
Supplement 6 Labeling Approved February 29, 2024 Standard
Supplement 5 Labeling Approved February 29, 2024 Standard
Supplement 4 Labeling Approved February 29, 2024 Standard
Supplement 1 Labeling Approved February 29, 2024 Standard
Original application 1 Approved April 22, 2016 Standard

Adverse event reports

Source: openFDA FAERS
5,980
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: MILNACIPRAN 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
65162-091-06 65162-091 Amneal Pharmaceuticals LLC 60 TABLET in 1 BOTTLE (65162-091-06) January 31, 2014
65162-092-06 65162-092 Amneal Pharmaceuticals LLC 60 TABLET in 1 BOTTLE (65162-092-06) January 31, 2014
65162-093-06 65162-093 Amneal Pharmaceuticals LLC 60 TABLET in 1 BOTTLE (65162-093-06) January 31, 2014
65162-093-50 65162-093 Amneal Pharmaceuticals LLC 500 TABLET in 1 BOTTLE (65162-093-50) January 31, 2014
65162-094-06 65162-094 Amneal Pharmaceuticals LLC 60 TABLET in 1 BOTTLE (65162-094-06) January 31, 2014
65162-094-50 65162-094 Amneal Pharmaceuticals LLC 500 TABLET in 1 BOTTLE (65162-094-50) January 31, 2014
65162-091 65162-091 Amneal Pharmaceuticals LLC — January 31, 2014
65162-092 65162-092 Amneal Pharmaceuticals LLC — January 31, 2014
65162-093 65162-093 Amneal Pharmaceuticals LLC — January 31, 2014
65162-094 65162-094 Amneal Pharmaceuticals LLC — January 31, 2014

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 · 10 sections on this page.