FETZIMA Extended release capsule Ref.[10811] Active ingredients: Milnacipran

Source: FDA, National Drug Code (US) Revision Year: 2019

Product description

Fetzima contains levomilnacipran hydrochloride, a selective serotonin and norepinephrine reuptake inhibitor (SNRI). The chemical name of levomilnacipran hydrochloride is (1S,2R)2(aminomethyl)-N,N-diethyl-1-phenylcyclopropanecarboxamide hydrochloride; its empirical formula is C₁₅H₂₃ClN₂O and its molecular weight is 282.8 g/mol. Levomilnacipran (Initial US approval: 2013) is the 1S,2R-enantiomer of milnacipran.

The chemical structure of levomilnacipran hydrochloride is:

FETZIMA extended-release capsules are intended for oral administration. Each FETZIMA capsule contains extended-release beads with 23.0, 45.9, 91.8, or 137.8 mg of levomilnacipran hydrochloride equivalent to 20, 40, 80, or 120 mg of levomilnacipran, respectively.

Inactive ingredients include ethylcellulose, hypromellose, povidone, sugar spheres, talc, titanium dioxide, and triethyl citrate. Inactive ingredients also include black iron oxide, red iron oxide (80 mg and 120 mg capsules only), shellac glaze, and yellow iron oxide (20 mg and 40 mg capsules only).

Dosage Forms and Strengths

FETZIMA (levomilnacipran) is available as 20 mg, 40 mg, 80 mg and 120 mg extended-release capsules.

Capsule Strength	Capsule Color/Shape	Capsule Markings
20 mg	yellow cap white body	black “FL” on cap black “20” on body
40 mg	yellow cap yellow body	black “FL” on cap black “40” on body
80 mg	pink cap white body	black “FL” on cap black “80” on body
120 mg	pink cap pink body	black “FL” on cap black “120” on body

How Supplied

FETZIMA extended-release capsules are supplied in the following configurations:

Capsule Strengt	Capsule Color/Shape	Capsule Markings	Package Configuration	NDC Code
20 mg	yellow cap white body	black “FL” on cap black “20” on body	Bottle / 30 count	0456-2220-30
20 mg	yellow cap white body	black “FL” on cap black “20” on body	Hospital Unit Dose (Blister) / 10 × 10	0456-2220-63
40 mg	yellow cap yellow body	black “FL” on cap black “40” on body	Bottle / 30 count	0456-2240-30
			Bottle / 90 count	0456-2240-90
			Hospital Unit Dose (Blister) / 10 × 10	0456-2240-63
80 mg	pink cap white body	black “FL” on cap black “80” on body	Bottle / 30 count	0456-2280-30
			Bottle / 90 count	0456-2280-90
			Hospital Unit Dose (Blister) /10 × 10	0456-2280-63
120 mg	pink cap pink body	black “FL” on cap black “120” on body	Bottle / 30 count	0456-2212-30
			Bottle / 90 count	0456-2212-90
			Hospital Unit Dose (Blister) / 10 × 10	0456-2212-63

FETZIMA Titration Pack is supplied in the following configuration:

Capsule Strength	Capsule Color/Shape	Capsule Markings	Package Configuration	NDC Code
20 mg	yellow cap white body	black “FL” on cap black “20” on body	Titration Pack (Blister) containing two 20 mg capsules and twenty-six 40 mg capsules	0456-2202-28
40 mg	yellow cap yellow body	black “FL” on cap black “40” on body		0456-2202-28

Distributed by: Allergan USA, Inc., Madison, NJ 07940

Drugs

Drug	Countries
FETZIMA	Canada, United Kingdom, United States

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