pramipexole 3 mg
1 INDICATIONS AND USAGE Pramipexole dihydrochloride extended-release tablets are indicated for the treatment of Parkinson’s disease. Pramipexole dihydrochloride is a non-ergot dopamine agonist indicated for the treatment of Parkinson’s disease (PD)(1)
alembic pharmaceuticals inc.
OVAL WHITE ER 404
ER 404 OVAL WHITE
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16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied
PRAMIPEXOLE DIHYDROCHLORIDE Extended-Release Tablets are available as follows: 0. 375 mg: white to off white, round, biconvex, uncoated extended-release tablets debossed with ‘401’ on one side and ‘ER’ on other side. NDC 62332-154-30 bottle of 30 tablets 0.75 mg: white to off white, round, biconvex, uncoated extended-release tablets debossed with ‘402’ on one side and ‘ER’ on other side. NDC 62332-155-30 bottle of 30 tablets 1.5 mg: white to off white, oval, biconvex, uncoated extended-release tablets debossed with ‘403’ on one side and ‘ER’ on other side. NDC 62332-156-30 bottle of 30 tablets 2.25 mg: white to off white, oval, biconvex, uncoated extended-release tablets debossed with ‘413’ on one side and ‘ER’ on other side. NDC 62332-157-30 bottle of 30 tablets 3 mg: white to off white, oval, biconvex, uncoated extended-release tablets debossed with ‘404’ on one side and ‘ER’ on other side. NDC 62332-158-30 bottle of 30 tablets 3.75 mg: white to off white, oval, biconvex, uncoated extended-release tablets debossed with ‘414’ on one side and ‘ER’ on other side. NDC 62332-160-30 bottle of 30 tablets 4.5 mg: white to off white, oval, biconvex, uncoated extended-release tablets debossed with ‘405’ on one side and ‘ER’ on other side. NDC 62332-159-30 bottle of 30 tablets 16.2 Storage and Handling Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect from exposure to high humidity. Store in a safe place out of the reach of children.
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