Source: FDA, National Drug Code (US) Revision Year: 2019
Trandolapril and verapamil hydrochloride extended-release tablets combine a slow release formulation of a calcium channel blocker, verapamil hydrochloride, USP, and an immediate release formulation of an angiotensin converting enzyme inhibitor, trandolapril, USP.
Verapamil hydrochloride, USP is chemically described as benzeneacetonitrile, α [3-[[2-(3,4-dimethoxyphenyl) -ethyl] methylamino] propyl] -3,4-dimethoxy-α -(1-methylethyl)-, monohydrochloride, (±). Its molecular formula is C27H38N2O4 • HCl and its structural formula is:
Verapamil hydrochloride, USP is a white or practically white crystalline powder, with a molecular weight of 491.06 g/mol. It is soluble in water, freely soluble in chloroform, sparingly soluble in alcohol and practically insoluble in ether. It is practically odorless and has a bitter taste.
Trandolapril, USP is the ethyl ester prodrug of a nonsulfhydryl angiotensin converting enzyme (ACE) inhibitor, trandolaprilat. It is chemically described as (2S,3aR,7aS)1[(S)2[[(S)1(EthoxyCarbonyl)-3-phenylpropyl] amino]Propanoyl]octahydro-1H-indole-2-carboxylic acid. Its molecular formula is C24H34N2O5 and its structural formula is:
Trandolapril, USP is a white or almost white powder with a molecular weight of 430.54 g/mol. It is practically insoluble in water; freely soluble in methylene chloride; sparingly soluble in absolute alcohol.
Trandolapril and verapamil hydrochloride extended-release tablets are formulated for oral administration, containing verapamil hydrochloride, USP as a controlled release formulation and trandolapril, USP as an immediate release formulation. The tablet strengths are trandolapril and verapamil hydrochloride extended-release tablets 1 mg/240 mg, trandolapril and verapamil hydrochloride extended-release tablets 2 mg/180 mg, trandolapril and verapamil hydrochloride extended-release tablets 2 mg/240 mg, and trandolapril and verapamil hydrochloride extended-release tablets 4 mg/240 mg. The tablets also contain the following ingredients: colloidal silicon dioxide, corn starch, croscarmellose sodium, ferric oxide red, hypromellose, lactose monohydrate, povidone, sodium alginate, sodium stearyl fumarate, magnesium stearate, and microcrystalline cellulose. The film coating contains: 1 mg/240 mg – hypromellose, titanium dioxide, and polyethylene glycol; 2 mg/180 mg – hypromellose, titanium dioxide, polyethylene glycol, iron oxide red, and FD&C blue #2; 2 mg/240 mg – hypromellose, titanium dioxide, polyethylene glycol, iron oxide yellow, iron oxide black, and iron oxide red; 4 mg/240 mg – hypromellose, titanium dioxide, polyethylene glycol, iron oxide yellow, iron oxide red, and iron oxide black.
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Trandolapril and Verapamil Hydrochloride Extended-Release Tablets, 1 mg/240 mg are supplied as white to pinkish white colored, oval, biconvex, film-coated tablets with ‘294’ debossed on one side and plain on the other side containing 1 mg trandolapril, USP in an immediate-release form and 240 mg verapamil hydrochloride, USP in an extended-release form. NDC 68462-294-90 — bottles of 90 NDC 68462-294-01 — bottles of 100 NDC 68462-294-10 — bottles of 1000 Trandolapril and Verapamil Hydrochloride Extended-Release Tablets, 2 mg/180 mg are supplied as pink colored, oval, biconvex, film-coated tablets with ‘295’ debossed on one side and plain on the other side containing 2 mg trandolapril, USP in an immediate-release form and 180 mg verapamil hydrochloride, USP in an extended-release form. NDC 68462-295-90 — bottles of 90 NDC 68462-295-01 — bottles of 100 NDC 68462-295-10 — bottles of 1000 Trandolapril and Verapamil Hydrochloride Extended-Release Tablets, 2 mg/240 mg are supplied as cream colored, oval, biconvex, film-coated tablets with ‘296’ debossed on one side and plain on the other side containing 2 mg trandolapril, USP in an immediate-release form and 240 mg verapamil hydrochloride, USP in an extended-release form. NDC 68462-296-90 — bottles of 90 NDC 68462-296-01 — bottles of 100 NDC 68462-296-10 — bottles of 1000 Trandolapril and Verapamil Hydrochloride Extended-Release Tablets, 4 mg/240 mg are supplied as brown colored, oval, biconvex, film-coated tablets with ‘G38’ debossed on one side and plain on the other side containing 4 mg trandolapril, USP in an immediate-release form and 240 mg verapamil hydrochloride, USP in an extended-release form. NDC 68462-329-01 — bottles of 100 NDC 68462-329-10 — bottles of 1000 Dispense in well-closed container with safety closure. Manufactured by: Glenmark Pharmaceuticals Ltd., Colvale-Bardez, Goa 403513, India Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430 |
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