BEQALZI Film-coated tablet Ref.[116693] Active ingredients: Sonrotoclax

Source: FDA, National Drug Code (US) Revision Year: 2026

Product description

BEQALZI tablets contain sonrotoclax, a B-cell lymphoma 2 (BCL-2) inhibitor. The molecular formula of sonrotoclax is C49H59N7O7S and the chemical name is N-[4-({[(1r,4r)-4-hydroxy-4-methylcyclohexyl]methyl}amino)-3-nitrobenzene-1-sulfonyl]-4-(2-{(2S)-2-[2-(propan-2-yl)phenyl]pyrrolidin-1-yl}-7-azaspiro[3.5]nonan-7-yl)-2-[(1H-pyrrolo[2,3- b]pyridin-5-yl)oxy]benzamide.

The molecular weight of sonrotoclax is 890.11 Daltons.

Sonrotoclax has the following structure:

BEQALZI tablets for oral use contain 1, 5, 20, or 80 mg of sonrotoclax. Each tablet contains the following inactive ingredients: anhydrous dibasic calcium phosphate, colloidal silicon dioxide (20 and 80 mg only), croscarmellose sodium, hydroxypropyl methylcellulose acetate succinate, magnesium stearate, microcrystalline cellulose, talc (20 and 80 mg only). The tablet film coating contains FD&C Blue No. 1/brilliant blue FCF aluminum lake, FD&C Red No. 40/allura red ac aluminum lake, polyethylene glycol, polyvinyl alcohol, soy lecithin, talc, and titanium dioxide.

Dosage Forms and Strengths

Tablet Strength	Description
1 mg	Purple, oval, film-coated tablets with 1 debossed on one side.
5 mg	Purple, oval, film-coated tablets with 5 debossed on one side.
20 mg	Purple, oblong, film-coated tablets with 20 debossed on one side.
80 mg	Purple, oval, film-coated tablets with 80 debossed on one side.

How Supplied

Package	Number of Tablets	NDC Number
Starter pack carton	Each starter pack carton contains 4 weekly blister pack wallets: • Week 1 (11 × 1 mg tablets) • Week 2 (11 × 5 mg tablets) • Week 3 (11 × 20 mg tablets) • Week 4 (11 × 80 mg tablets)	72579-015-04
Individual restart packs
1 mg wallet in carton (Week 1 wallet)	11 × 1 mg tablets	72579-020-01
5 mg wallet in carton (Week 2 wallet)	11 × 5 mg tablets	72579-017-01
20 mg wallet in carton (Week 3 wallet)	11 × 20 mg tablets	72579-025-01
80 mg wallet in carton (Week 4 wallet)	11 × 80 mg tablets	72579-022-01
Additional packs
20 mg wallet in carton	14 × 20 mg tablets	72579-025-02
80 mg bottle in carton	120 × 80 mg tablets	72579-022-08

BEQALZI 1 mg film-coated tablets are purple, oval, and debossed with 1 on one side.

BEQALZI 5 mg film-coated tablets are purple, oval, and debossed with 5 on one side.

BEQALZI 20 mg film-coated tablets are purple, oblong, and debossed with 20 on one side.

BEQALZI 80 mg film-coated tablets are purple, oval, and debossed with 80 on one side.

Manufactured for: BeOne Medicines USA, Inc., Pennington, NJ 08534

Drugs

Drug	Countries
BEQALZI	United States

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