APTIOM Tablet Ref.[10749] Active ingredients: Eslicarbazepine

Source: FDA, National Drug Code (US) Revision Year: 2020

Product description

The chemical name of APTIOM (eslicarbazepine acetate) is (S)-10-Acetoxy-10,11-dihydro-5H-dibenz[b,f]azepine-5-carboxamide. APTIOM is a dibenz[b,f]azepine-5-carboxamide derivative. Its molecular formula is C₁₇H₁₆N₂O₃ and its molecular weight is 296.32.

The chemical structure is:

APTIOM is a white to off-white, odorless crystalline solid. It is insoluble in hexane, very slightly soluble in aqueous solvents and soluble in organic solvents such as acetone, acetonitrile, and methanol.

Each APTIOM tablet contains 200 mg, 400 mg, 600 mg or 800 mg of eslicarbazepine acetate and the following inactive ingredients: croscarmellose sodium, magnesium stearate, and povidone.

Dosage Forms and Strengths

APTIOM tablets are available in the following shapes and color (Table 2) with respective one-sided engraving:

Table 2. APTIOM Tablet Presentations:

Tablet Strength	Tablet Color/Shape	Tablet Markings	Functional Score
200 mg	White oblong	ESL 200	Yes
400 mg	White circular bi-convex	ESL 400	No
600 mg	White oblong	ESL 600	Yes
800 mg	White oblong	ESL 800	Yes

How Supplied

APTIOM tablets are white, oblong and with functional scoring on one side (200 mg, 600 mg, and 800 mg) or white, circular bi-convex and plain on one side (400 mg) and identified with strength-specific one-sided engraving on the other side, "ESL 200" (200 mg), "ESL 400" (400 mg), "ESL 600" (600 mg), or "ESL 800" (800 mg). Tablets are supplied in the following strengths and package configurations (Table 6):

Table 6. Package Configuration for APTIOM Tablets:

Tablet Strength	Package Configuration	NDC Code
200 mg	Bottles of 30	63402-202-30
400 mg	Bottles of 30	63402-204-30
600 mg	Bottles of 60	63402-206-60
800 mg	Bottles of 30	63402-208-30

Manufactured for: Sunovion Pharmaceuticals Inc., Marlborough, MA 01752 USA

Under license from Bial

Drugs

Drug	Countries
APTIOM	Canada, United States

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