VENCLEXTA Film coated tablet Ref.[11111] Active ingredients: Venetoclax

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

Product description

Venetoclax is a BCL-2 inhibitor. It is a light yellow to dark yellow solid with the empirical formula C45H50ClN7O7S and a molecular weight of 868.44. Venetoclax is described chemically as 4-(4-{[2-(4-chlorophenyl)-4,4-dimethylcyclohex-1-en-1-yl]methyl}piperazin-1-yl)N({3-nitro-4-[(tetrahydro-2H-pyran-4-ylmethyl)amino]phenyl}sulfonyl)2(1Hpyrrolo[2,3b]pyridin-5-yloxy)benzamide) and has the following chemical structure:

Venetoclax has very low aqueous solubility.

VENCLEXTA tablets for oral use are supplied as pale yellow or beige tablets that contain 10, 50, or 100 mg venetoclax as the active ingredient. Each tablet also contains the following inactive ingredients: copovidone, colloidal silicon dioxide, polysorbate 80, sodium stearyl fumarate, and calcium phosphate dibasic. In addition, the 10 mg and 100 mg coated tablets include the following: iron oxide yellow, polyvinyl alcohol, polyethylene glycol, talc, and titanium dioxide. The 50 mg coated tablets also include the following: iron oxide yellow, iron oxide red, iron oxide black, polyvinyl alcohol, talc, polyethylene glycol and titanium dioxide. Each tablet is debossed with “V” on one side and “10”, “50” or “100” corresponding to the tablet strength on the other side.

Dosage Forms and Strengths

Table 8. VENCLEXTA Tablet Strength and Description:

Tablet StrengthDescription of Tablet
10 mg Round, biconvex shaped, pale yellow film-coated tablet debossed with “V” on one side and “10” on the other side
50 mg Oblong, biconvex shaped, beige film-coated tablet debossed with “V” on one side and “50” on the other side
100 mg Oblong, biconvex shaped, pale yellow film-coated tablet debossed with “V” on one side and “100” on the other side
How Supplied

VENCLEXTA is dispensed as follows:

Packaging PresentationNumber of TabletsNational Drug Code (NDC)
CLL/SLL Starting Pack Each pack contains four weekly wallet blister packs:• Week 1 (14 × 10 mg tablets)
• Week 2 (7 × 50 mg tablets)
• Week 3 (7 × 100 mg tablets)
• Week 4 (14 × 100 mg tablets)
0074-0579-28
Wallet containing 10 mg tablets 14 × 10 mg tablets 0074-0561-14
Wallet containing 50 mg tablets 7 × 50 mg tablets 0074-0566-07
Unit dose blister containing 10 mg tablets 2 × 10 mg tablets 0074-0561-11
Unit dose blister containing 50 mg tablet 1 × 50 mg tablet 0074-0566-11
Unit dose blister containing 100 mg tablet 1 × 100 mg tablet 0074-0576-11
Bottle containing 100 mg tablets 120 × 100 mg tablets 0074-0576-22
Bottle containing 100 mg tablets 180 × 100 mg tablets 0074-0576-34

VENCLEXTA 10 mg film-coated tablets are round, biconvex shaped, pale yellow debossed with “V” on one side and “10” on the other side.

VENCLEXTA 50 mg film-coated tablets are oblong, biconvex shaped, beige debossed with “V” on one side and “50” on the other side.

VENCLEXTA 100 mg film-coated tablets are oblong, biconvex shaped, pale yellow debossed with “V” on one side and “100” on the other side.

Manufactured and Marketed by: AbbVie Inc., North Chicago, IL 60064

and

Marketed by: Genentech USA, Inc., A Member of the Roche Group, South San Francisco, CA 94080-4990

Drugs

Drug Countries
VENCLEXTA Australia, Brazil, Canada, Ecuador, Hong Kong, Israel, Japan, New Zealand, Singapore, United States

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