Source: FDA, National Drug Code (US) Revision Year: 2021
THALOMID, α-(N-phthalimido) glutarimide, is an immunomodulatory agent. The empirical formula for thalidomide is C13H10N2O4 and the gram molecular weight is 258.2. The CAS number of thalidomide is 50-35-1.
Chemical Structure of Thalidomide:
Note: ∙ = asymmetric carbon atom
Thalidomide is an off-white to white, odorless, crystalline powder that is soluble at 25°C in dimethyl sulfoxide and sparingly soluble in water and ethanol. The glutarimide moiety contains a single asymmetric center and, therefore, may exist in either of two optically active forms designated S - ( - ) or R - ( + ). THALOMID is an equal mixture of the S - ( - ) and R - ( + ) forms and, therefore, has a net optical rotation of zero.
THALOMID is available in 50 mg, 100 mg, 150 mg and 200 mg capsules for oral administration. Active ingredient: thalidomide. Inactive ingredients: pregelatinized starch and magnesium stearate. The 50 mg capsule shell contains gelatin, titanium dioxide, and black ink. The 100 mg capsule shell contains black iron oxide, yellow iron oxide, titanium dioxide, gelatin, and black ink. The 150 mg capsule shell contains FD&C blue #2, black iron oxide, yellow iron oxide, titanium dioxide, gelatin, and black and white ink. The 200 mg capsule shell contains FD&C blue #2, titanium dioxide, gelatin, and white ink.
Dosage Forms and Strengths |
---|
Capsules:
|
How Supplied |
---|
(THIS PRODUCT IS ONLY SUPPLIED TO PHARMACIES CERTIFIED IN THE THALOMID REMS PROGRAM – See BOXED WARNING) 50 mg capsules [white opaque], imprinted “Celgene/50 mg” with a “Do Not Get Pregnant” logo. 100 mg capsules [tan], imprinted “Celgene/100 mg” with a “Do Not Get Pregnant” logo. 150 mg capsules [tan and blue], imprinted “Celgene/150 mg” with a “Do Not Get Pregnant” logo. 200 mg capsules [blue], imprinted “Celgene/200 mg” with a “Do Not Get Pregnant” logo. Manufactured for Celgene Corporation, 86 Morris Avenue, Summit, NJ 07901 |
Drug | Countries | |
---|---|---|
THALOMID | Australia, New Zealand, United States |
© 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.