ENSACOVE Capsule Ref.[115492] Active ingredients: Ensartinib

Source: FDA, National Drug Code (US) Revision Year: 2024

Product description

ENSACOVE capsules contain ensartinib, a kinase inhibitor, present as ensartinib hydrochloride with the chemical name 6-amino-5-[(1R)-1-(2,6-dichloro-3-fluorophenyl)ethoxy]-N-{4-[(3R,5S)- 3,5-dimethylpiperazine-1-carbonyl]phenyl}pyridazine-3-carboxamide, dihydrochloride.

The molecular formula is C26H27Cl2FN6O3·2HCl and its molecular weight is 634.4 g/mol with the following structure:

ENSACOVE capsules are intended for oral administration and are available in two dosage strengths: 25 mg ensartinib (equivalent to 28.25 mg ensartinib hydrochloride) and 100 mg ensartinib (equivalent to 113.02 mg ensartinib hydrochloride).

The inactive ingredients of ENSACOVE capsules are microcrystalline cellulose and stearic acid. The inactive ingredients of the 25 mg empty capsule shells are hypromellose and titanium dioxide. The inactive ingredients of the 100 mg empty capsules shells are black iron oxide, FD&C Blue No. 1, FD&C Yellow No. 5, hypromellose, red iron oxide, and titanium dioxide.

The imprinting ink for the 25 mg capsules contains butyl alcohol, dehydrated alcohol, FD&C Blue No. 2, isopropyl alcohol, propylene glycol, shellac, and strong ammonia solution. The imprinting ink for the 100 mg capsules contains butyl alcohol, dehydrated alcohol, isopropyl alcohol, povidone, propylene glycol, shellac, sodium hydroxide, and titanium dioxide.

Dosage Forms and Strengths
ENSACOVE capsules are available as: 25 mg: size 2 capsule, white opaque cap and body, with "X-396" on the cap and "25 mg" on the body printed in blue ink. Each capsule contains the equivalent of 25 mg of ensartinib. 100 mg: size 0 capsule, blue opaque cap and yellow opaque body, with "X-396" on the cap and "100 mg" on the body printed in white ink. Each capsule contains the equivalent of 100 mg of ensartinib.

Dosage Forms and Strengths

ENSACOVE capsules are available as:

25 mg: size 2 capsule, white opaque cap and body, with "X-396" on the cap and "25 mg" on the body printed in blue ink. Each capsule contains the equivalent of 25 mg of ensartinib.
100 mg: size 0 capsule, blue opaque cap and yellow opaque body, with "X-396" on the cap and "100 mg" on the body printed in white ink. Each capsule contains the equivalent of 100 mg of ensartinib.

How Supplied

ENSACOVE (ensartinib) capsules are supplied as follows:

Capsule Strength	Description	Package Configuration	NDC Code
25 mg	Size 2 capsule, white opaque cap and body, with "X-396" on the cap and "25 mg" on the body printed in blue ink.	Bottles of 30	83076-1025-3
100 mg	Size 0 capsule, blue opaque cap and yellow opaque body, with "X-396" on the cap and "100 mg" on the body printed in white ink.	Bottles of 60	83076-1100-6

Manufactured for: Xcovery Holdings, Inc. Miami, FL 33131

Drugs

Drug	Countries
ENSACOVE	United States

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