KADIAN Capsule extended-release Ref.[10855] Active ingredients: Morphine

Source: FDA, National Drug Code (US)  Revision Year: 2019 

Product description

KADIAN (morphine sulfate) extended-release capsules, an opioid agonist, are for oral use and contain pellets of morphine sulfate.

Each KADIAN extended-release capsule contains either 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, 80 mg, 100 mg, or 200 mg of morphine sulfate, USP and the following inactive ingredients common to all strengths: hypromellose, ethylcellulose, methacrylic acid copolymer, polyethylene glycol, diethyl phthalate, talc, corn starch, and sucrose.

The capsule shells contain gelatin, silicon dioxide, sodium lauryl sulfate, titanium dioxide, and black ink, D&C red #28, FD&C blue #1 (10 mg), D&C yellow #10 (20 mg), FD&C red #3, FD&C blue #1 (30 mg), D&C yellow #10, FD&C blue #1, FD&C red #3 (40 mg), D&C red #28, FD&C red #40, FD&C blue #1 (50 mg), D&C red #28, FD&C red #40, FD&C blue #1 (60 mg), FD&C blue #1, FD&C red #40, FD&C yellow #6 (80 mg), D&C yellow #10, FD&C blue #1 (100 mg) black iron oxide, yellow iron oxide, red iron oxide (200 mg). The imprint ink contains black iron oxide, potassium hydroxide, propylene glycol, and shellac.

The chemical name of morphine sulfate is 7,8-didehydro-4,5 α-epoxy-17-methyl-morphinan-3,6 α-diol sulfate (2:1) (salt) pentahydrate. The empirical formula is (C17H19NO3)2•H2SO4•5H2O and its molecular weight is 758.85.

Morphine sulfate is an odorless, white, crystalline powder with a bitter taste. It has a solubility of 1 in 21 parts of water and 1 in 1000 parts of alcohol, but is practically insoluble in chloroform or ether. The octanol: water partition coefficient of morphine is 1.42 at physiologic pH and the pKb is 7.9 for the tertiary nitrogen (mostly ionized at pH 7.4).

Its structural formula is:

Dosage Forms and Strengths

Extended-release capsules: 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, 80 mg, 100 mg, 200 mg. KADIAN contains white to off-white or tan colored polymer coated pellets, have an outer opaque capsule with colors as identified below and are available in nine dose strengths:

Each 10 mg extended-release capsule has a light blue opaque cap printed with “KADIAN” and a light blue opaque body printed with “10 mg”.
Each 20 mg extended-release capsule has a yellow opaque cap printed with “KADIAN” and a yellow opaque body printed with “20 mg”.
Each 30 mg extended-release capsule has a blue violet opaque cap printed with “KADIAN” and a blue violet opaque body printed with “30 mg”.
Each 40 mg extended-release capsule has a yellow opaque cap printed with “KADIAN” and a blue violet opaque body printed with “40 mg”.
Each 50 mg extended-release capsule has a blue opaque cap printed with “KADIAN” and a blue opaque body printed with “50 mg”.
Each 60 mg extended-release capsule has a pink opaque cap printed with “KADIAN” and a pink opaque body printed with “60 mg”.
Each 80 mg extended-release capsule has a light orange opaque cap printed with “KADIAN” and a light orange opaque body printed with “80 mg”.
Each 100 mg extended-release capsule has a green opaque cap printed with “KADIAN” and a green opaque body printed with “100 mg”.
Each 200 mg extended-release capsule has a light brown opaque cap printed with “KADIAN” and light brown opaque body printed with “200 mg”.
How Supplied

KADIAN extended-release capsules contain white to off-white or tan colored polymer coated extended-release pellets of morphine sulfate and are available in nine dose strengths.

 KADIAN 10 mgKADIAN 20 mgKADIAN 30 mgKADIAN 40 mg
Extended-Release Capsule Descriptionsize 4, light blue opaque cap printed with “KADIAN” and light blue opaque body printed with “10 mg”. size 4, yellow opaque cap printed with “KADIAN” and yellow opaque body printed with “20 mg”. size 4, blue violet opaque cap printed with “KADIAN” and blue violet opaque body printed with “30 mg”. size 2, yellow opaque cap printed with “KADIAN” and blue violet opaque body printed with “40 mg”.
Bottle Size60 60 60 60
NDC # NDC 0023-6011-60 NDC 0023-6012-60 NDC 0023-6013-60 NDC 0023-6014-60
 KADIAN 50 mgKADIAN 60 mgKADIAN 80 mg
Extended-Release Capsule Descriptionsize 2, blue opaque cap printed with “KADIAN” and blue opaque body printed with “50 mg”. size 1, pink opaque cap printed with “KADIAN” and pink opaque body printed with “60 mg”. size 0, light orange opaque cap printed with “KADIAN” and light orange opaque body printed with “80 mg”.
Bottle Size60 60 60
NDC #NDC 0023-6015-60 NDC 0023-6016-60 NDC 0023-6017-60
 KADIAN 100 mgKADIAN 200 mg
Extended-Release Capsule Descriptionsize 0, green opaque cap printed with “KADIAN” and green opaque body printed with “100 mg”. size 0, light brown opaque cap printed with “KADIAN” and light brown opaque body printed with “200 mg”.
Bottle Size60 60
NDC #NDC 0023-6018-60 NDC 0023-6019-60

Distributed by: Allergan USA, Inc., Madison, NJ 07940

Drugs

Drug Countries
KADIAN Canada, United States
 
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