Source: FDA, National Drug Code (US) Revision Year: 2021
The active ingredient levamlodipine maleate is the maleate salt of levamlodipine, the pharmacologically active isomer of amlodipine, a long-acting calcium channel blocker.
Levamlodipine maleate is chemically described as (S)3-ethyl-5-methyl-2-(2-aminoethoxymethyl)4(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate maleate, and its structural formula is:
Levamlodipine maleate is an off-white to light yellow crystalline powder with a molecular weight of 524.95. It is slightly soluble in water and sparingly soluble in ethanol. CONJUPRI (levamlodipine) tablets are formulated as white to off-white tablets containing 1.25, 2.5, and 5 mg of levamlodipine (equivalent to 1.6, 3.2, and 6.4 mg of levamlodipine maleate respectively), for oral administration. In addition to the active ingredient, levamlodipine maleate, each tablet contains the following inactive ingredients: betadex, colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, and pregelatinized starch.
| Dosage Forms and Strengths |
|---|
|
Tablet, 1.25 mg is white to off-white, oval, biconvex tablet, engraved with “OE” on one side and “B46” on the other side. Tablet, 2.5 mg is white to off-white, capsule shaped, flat-faced tablet with functional score on each side, engraved with “OE” on one side and “B47” on the other side. Tablet, 5 mg is white to off-white, soap shaped, flat-faced tablet with functional score on each side, engraved with “OE” on one side and “B48” on the other side. |
| How Supplied |
|---|
1.25 mg TabletsLevamlodipine – 1.25 mg tablets are supplied as white to off-white, oval, biconvex tablet, engraved with “OE” on one side and “B46” on the other side and supplied as follows: NDC 69101-512-30 Bottle of 30 tablets with child-resistant closure 2.5 mg TabletsLevamlodipine – 2.5 mg tablets are supplied as white to off-white, capsule shaped, flat-faced tablet with functional score on each side, engraved with “OE” on one side and “B47” on the other side and supplied as follows: NDC 69101-525-30 Bottle of 30 tablets with child-resistant closure 5 mg TabletsLevamlodipine – 5 mg tablets are supplied as white to off-white, soap shaped, flat-faced tablet with functional score on each side, engraved with “OE” on one side and “B48” on the other side and supplied as follows: NDC 69101-550-30 Bottle of 30 tablets with child-resistant closure Manufactured by: CSPC Ouyi Pharmaceutical Co., Ltd., Shijiazhuang, Hebei, China, 052160 Distributed by: Burke Therapeutics, LLC, Hot Springs, AR 71913, USA |
| Drug | Countries | |
|---|---|---|
| CONJUPRI | United States |
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