Source: FDA, National Drug Code (US) Revision Year: 2022
SEROQUEL (quetiapine) is an atypical antipsychotic belonging to a chemical class, the dibenzothiazepine derivatives. The chemical designation is 2-[2-(4-dibenzo [b,f] [1,4]thiazepin-11-yl-1-piperazinyl)ethoxy]-ethanol fumarate (2:1) (salt). It is present in tablets as the fumarate salt. All doses and tablet strengths are expressed as milligrams of base, not as fumarate salt. Its molecular formula is C42H50N6O4S2âĒC4H4O4 and it has a molecular weight of 883.11 (fumarate salt).
The structural formula is:
Quetiapine fumarate is a white to off-white crystalline powder which is moderately soluble in water.
SEROQUEL is supplied for oral administration as 25 mg (round, peach), 50 mg (round, white), 100 mg (round, yellow), 200 mg (round, white), 300 mg (capsule-shaped, white), and 400 mg (capsule-shaped, yellow) tablets.
Inactive ingredients are povidone, dibasic dicalcium phosphate dihydrate, microcrystalline cellulose, sodium starch glycolate, lactose monohydrate, magnesium stearate, hypromellose, polyethylene glycol, and titanium dioxide.
The 25 mg tablets contain red ferric oxide and yellow ferric oxide and the 100 mg and 400 mg tablets contain only yellow ferric oxide.
Each 25 mg tablet contains 28.78 mg of quetiapine fumarate equivalent to 25 mg quetiapine. Each 50 mg tablet contains 57.56 mg of quetiapine fumarate equivalent to 50 mg quetiapine. Each 100 mg tablet contains 115.13 mg of quetiapine fumarate equivalent to 100 mg quetiapine. Each 200 mg tablet contains 230.26 mg of quetiapine fumarate equivalent to 200 mg quetiapine. Each 300 mg tablet contains 345.39 mg of quetiapine fumarate equivalent to 300 mg quetiapine. Each 400 mg tablet contains 460.51 mg of quetiapine fumarate equivalent to 400 mg quetiapine.
| Dosage Forms and Strengths |
|---|
|
| How Supplied |
|---|
|
25 mg Tablets (NDC 0310-0275-10) peach, round, biconvex, film coated tablets, identified with ‘SEROQUEL’ and ‘25’ on one side and plain on the other side, are supplied in bottles of 100 tablets. 50 mg Tablets (NDC 0310-0278-10) white, round, biconvex, film coated tablets, identified with ‘SEROQUEL’ and ‘50’ on one side and plain on the other side, are supplied in bottles of 100 tablets. 100 mg Tablets (NDC 0310-0271-10) yellow, round, biconvex film coated tablets, identified with ‘SEROQUEL’ and ‘100’ on one side and plain on the other side, are supplied in bottles of 100 tablets. 200 mg Tablets (NDC 0310-0272-10) white, round, biconvex, film coated tablets, identified with ‘SEROQUEL’ and ‘200’ on one side and plain on the other side, are supplied in bottles of 100 tablets. 300 mg Tablets (NDC 0310-0274-60) white, capsule-shaped, biconvex, film coated tablets, intagliated with ‘SEROQUEL’ on one side and ‘300’ on the other side, are supplied in bottles of 60 tablets. 400 mg Tablets (NDC 0310-0279-10) yellow, capsule-shaped, biconvex, film coated tablets, intagliated with ‘SEROQUEL’ on one side and ‘400’ on the other side, are supplied in bottles of 100 tablets. Distributed by: AstraZeneca Pharmaceuticals LP, Wilmington, DE 19850 |
| Drug | Countries | |
|---|---|---|
| SEROQUEL | Austria, Australia, Brazil, Canada, Cyprus, Germany, Ecuador, Estonia, Spain, Finland, Hong Kong, Croatia, Ireland, Israel, Italy, Japan, Lithuania, Malta, Mexico, Netherlands, New Zealand, Romania, Singapore, Tunisia, Turkey, United Kingdom, United States, South Africa |
ÂĐ All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.
