SPL Set ID: 726a127b-03b2-44e8-a63d-078b35e27525

1 drug(s) with this SPL Set ID

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Carbamazepine CARBAMAZEPINE
ALEMBIC PHARMACEUTICALS INC. FDA Rx Only

Carbamazepine, USP, is an anticonvulsant and specific analgesic for trigeminal neuralgia, available for oral administration as extended-release tablets of 100, 200, and 400 mg. Its chemical name is 5 H -dibenz[ b,f ]azepine-5-carboxamide, and its structural formula is: Carbamazepine, USP is a white to off-white powder, soluble in alcohol, sparingly soluble in acetone and practically insoluble in water. Its molecular weight is 236.27 g/mol. Inactive Ingredients : cellulose acetate, dextrates, hydroxyethyl cellulose, hypromellose, magnesium stearate, mannitol, polyethylene glycol 8000 and sodium lauryl sulfate. Additionally, 100 mg tablet contains ferric oxide yellow, 200 mg tablet contains ferric oxide red and 400 mg tablet contains ferric oxide red as well as ferric oxide yellow. Tablets are imprinted with edible black ink containing ferrosoferric oxide, propylene glycol and shellac. FDA approved dissolution test specifications differ from USP. structure

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