THALOMID Capsule Ref.[27595] Active ingredients: Thalidomide

Source: FDA, National Drug Code (US)  Revision Year: 2021 

Product description

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:

  • 50 mg white, printed with “Celgene/50 mg” on the body and a “Do Not Get Pregnant” logo on the cap.
  • 100 mg tan, printed with “Celgene/100 mg” on the body and a “Do Not Get Pregnant” logo on the cap.
  • 150 mg tan body printed with “Celgene/150 mg” and blue cap printed with a “Do Not Get Pregnant” logo.
  • 200 mg blue, printed with “Celgene/200 mg” on the body and a “Do not Get Pregnant” logo on the cap.
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.
Individual blister packs of 1 capsule (NDC 59572-205-17).
Individual blister packs of 28 capsules (NDC 59572-205-14).

100 mg capsules [tan], imprinted “Celgene/100 mg” with a “Do Not Get Pregnant” logo.
Individual blister packs of 28 capsules (NDC 59572-210-15).

150 mg capsules [tan and blue], imprinted “Celgene/150 mg” with a “Do Not Get Pregnant” logo.
Individual blister packs of 28 capsules (NDC 59572-215-13).

200 mg capsules [blue], imprinted “Celgene/200 mg” with a “Do Not Get Pregnant” logo.
Individual blister packs of 28 capsules (NDC 59572-220-16).

Manufactured for Celgene Corporation, 86 Morris Avenue, Summit, NJ 07901

Drugs

Drug Countries
THALOMID Australia, New Zealand, United States

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