TOFRANIL Sugar-coated tablet Ref.[27551] Active ingredients: Imipramine

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

Product description

Tofranil is supplied in tablet form for oral administration.

Tofranil, imipramine hydrochloride USP, the original tricyclic antidepressant, is a member of the dibenzazepine group of compounds. It is designated 5-3-(dimethylamino)propyl-10,11-dihydro-5H-dibenz [b,f]-azepine monohydrochloride.

Its structural formula is:

Imipramine hydrochloride USP is a white to off-white, odorless, or practically odorless crystalline powder. It is freely soluble in water and in alcohol, soluble in acetone, and insoluble in ether and in benzene.

Inactive Ingredients: Calcium phosphate, cellulose compounds, docusate sodium, iron oxides, magnesium stearate, polyethylene glycol, povidone, sodium starch glycolate, sucrose, talc, and titanium dioxide.

How Supplied

The three strengths of Tofranil (imipramine hydrochloride USP) are available as follows:

Tablets 10 mg: triangular, biconvex, coral-reddish brown, sugar-coated tablet, imprinted with on one side and “10” on the other side in black.

Bottles of 30 NDC 0406-9920-03

Bottles of 100 NDC 0406-9920-01

Tablets 25 mg: round, biconvex, coral-reddish brown, sugar-coated tablet, imprinted with on one side and “25” on the other side in black.

Bottles of 30 NDC 0406-9921-03

Bottles of 100 NDC 0406-9921-01

Tablets 50 mg: round, biconvex, coral-reddish brown, sugar-coated tablet, imprinted with on one side and “50” on the other side in black.

Bottles of 30 NDC 0406-9922-03

Bottles of 100 NDC 0406-9922-01

Manufactured by: Patheon Inc., Whitby, Ontario, Canada

Manufactured for: SpecGx LLC, Webster Groves, MO 63119 USA

Drugs

Drug Countries
TOFRANIL Australia, Brazil, Spain, France, Japan, Mexico, New Zealand, Turkey, United States

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