POMALYST Capsule Ref.[10916] Active ingredients: Pomalidomide

Source: FDA, National Drug Code (US)  Revision Year: 2020 

Product description

Pomalidomide is a thalidomide analog. The chemical name is (RS)-4-Amino-2-(2,6-dioxo-piperidin-3-yl)-isoindoline-1,3-dione and it has the following chemical structure:

The empirical formula for pomalidomide is C13H11N3O4 and the gram molecular weight is 273.24.

Pomalidomide is a yellow solid powder. It has limited to low solubility into organic solvents and it has low solubility in all pH solutions (about 0.01 mg/mL). Pomalidomide has a chiral carbon atom which exists as a racemic mixture of the R(+) and S(-) enantiomers.

POMALYST is available in 1-mg, 2-mg, 3-mg, and 4-mg capsules for oral administration. Each capsule contains pomalidomide as the active ingredient and the following inactive ingredients: mannitol, pregelatinized starch, and sodium stearyl fumarate. The 1-mg capsule shell contains gelatin, titanium dioxide, FD&C blue 2, yellow iron oxide, white ink, and black ink. The 2-mg capsule shell contains gelatin, titanium dioxide, FD&C blue 2, yellow iron oxide, FD&C red 3, and white ink. The 3-mg capsule shell contains gelatin, titanium dioxide, FD&C blue 2, yellow iron oxide, and white ink. The 4-mg capsule shell contains gelatin, titanium dioxide, FD&C blue 1, FD&C blue 2, and white ink.

Dosage Forms and Strengths

Capsules:

  • 1 mg, dark blue opaque cap and yellow opaque body, imprinted “POML” on the cap in white ink and “1 mg” on the body in black ink.
  • 2 mg, dark blue opaque cap and orange opaque body, imprinted “POML” on the cap and “2 mg” on the body in white ink.
  • 3 mg, dark blue opaque cap and green opaque body, imprinted “POML” on the cap and “3 mg” on the body in white ink.
  • 4 mg, dark blue opaque cap and blue opaque body, imprinted “POML” on the cap and “4 mg” on the body in white ink.
How Supplied

Dark blue opaque cap and yellow opaque body, imprinted “POML” on the cap in white ink and “1 mg” on the body in black ink.

1 mg bottles of 21 (NDC 59572-501-21)
1 mg bottles of 100 (NDC 59572-501-00)

Dark blue opaque cap and orange opaque body, imprinted “POML” on the cap and “2 mg” on the body in white ink.

2 mg bottles of 21 (NDC 59572-502-21)
2 mg bottles of 100 (NDC 59572-502-00)

Dark blue opaque cap and green opaque body, imprinted “POML” on the cap and “3 mg” on the body in white ink.

3 mg bottles of 21 (NDC 59572-503-21)
3 mg bottles of 100 (NDC 59572-503-00)

Dark blue opaque cap and blue opaque body, imprinted “POML” on the cap and “4 mg” on the body in white ink.

4 mg bottles of 21 (NDC 59572-504-21)
4 mg bottles of 100 (NDC 59572-504-00)

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

Drugs

Drug Countries
POMALYST Australia, Canada, Ecuador, Hong Kong, Japan, New Zealand, Singapore, United States
 
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