Source: FDA, National Drug Code (US) Revision Year: 2022
Thiothixene is a thioxanthene derivative. Specifically, it is the cis isomer of N,N-dimethyl-9-[3-(4-methyl-1-piperazinyl)propylidene]thioxanthene-2-sulfonamide. It has a molecular formula C23H29N3O2S2 and the molecular weight is 443.63 g/mol.
The chemical structure is:
The thioxanthenes differ from the phenothiazines by the replacement of nitrogen in the central ring with a carbon-linked side chain fixed in space in a rigid structural configuration. An N,N-dimethyl sulfonamide functional group is bonded to the thioxanthene nucleus.
Each Thiothixene Capsules, USP contains 1 mg, 2 mg, 5 mg or 10 mg of thiothixene, USP and the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch and sodium lauryl sulfate.
Each empty hard gelatin capsule contains gelatin, iron oxide red, iron oxide yellow, purified water and titanium dioxide. In addition, the 1 mg hard gelatin capsule contains D&C yellow 10, FD&C blue 1 and FD&C red 40. The 2 mg hard gelatin capsule also contains D&C yellow 10 and ferrosoferric oxide. The 5 mg and 10 mg hard gelatin capsule also contains ferrosoferric oxide.
The capsule is imprinted with black pharmaceutical ink which contains ferrosoferric oxide, potassium hydroxide, propylene glycol and shellac.
| How Supplied |
|---|
|
Thiothixene Capsules USP, 1 mg are supplied as size ‘4’ hard gelatin capsules with a caramel opaque colored cap and a blue opaque colored body, imprinted ‘AA10A’ on body, with black ink containing white to off-white granular powder. They are available as follows: Bottles of 100 with child-resistant closure: NDC 60219-1673-1 Bottles of 1000: NDC 60219-1673-7 Thiothixene Capsules USP, 2 mg are supplied as size ‘4’ hard gelatin capsules with a caramel opaque colored cap and a yellow opaque colored body, imprinted ‘AA11A’ on body, with black ink containing white to off-white granular powder. They are available as follows: Bottles of 100 with child-resistant closure: NDC 60219-1674-1 Bottles of 1000: NDC 60219-1674-7 Thiothixene Capsules USP, 5 mg are supplied as size ‘4’ hard gelatin capsules with a caramel opaque colored cap and a white opaque colored body, imprinted ‘AA12A’ on body, with black ink containing white to off-white granular powder. They are available as follows: Bottles of 100 with child-resistant closure: NDC 60219-1675-1 Bottles of 1000: NDC 60219-1675-7 Thiothixene Capsules USP, 10 mg are supplied as size ‘4’ hard gelatin capsules with a caramel opaque colored cap and a peach opaque colored body, imprinted ‘AA13A’ on body, with black ink containing white to off-white granular powder. They are available as follows: Bottles of 100 with child-resistant closure: NDC 60219-1676-1 Bottles of 1000: NDC 60219-1676-7 Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Oral Solid Dosage Unit, Ahmedabad 382213, INDIA Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807 |
© 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.
