pramipexole dihydrochloride 0.25 MG Oral Tablet
1 INDICATIONS AND USAGE Pramipexole dihydrochloride tablets are a non-ergot dopamine agonist indicated for the treatment of: • Parkinson’s disease (PD) ( 1.1 ) • Moderate-to-severe primary Restless Legs Syndrome (RLS) ( 1.2 ) 1.1 Parkinson's Disease Pramipexole dihydrochloride tablets are indicated for the treatment of Parkinson's disease. 1.2 Restless Legs Syndrome Pramipexole dihydrochloride tablets are indicated for the treatment of moderate-to-severe primary Restless Legs Syndrome (RLS).
Glenmark Pharmaceuticals Inc., USA
OVAL WHITE PX 1
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16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied
PRAMIPEXOLE DIHYDROCHLORIDE Tablets are available as follows: 0.125 mg: circular, white, flat beveled tablets engraved with ‘PX’ on one side and plain on the other side. Bottles of 63 with child-resistant closure NDC 68462-330-63 Bottles of 90 with child-resistant closure NDC 68462-330-90 Bottles of 500 with child-resistant closure NDC 68462-330-05 Unit-dose pack of 100 (10 x 10) NDC 68462-330-11 0.25 mg: oval, white, flat beveled tablets engraved with ‘PX’ and ‘1’ on either side of a break line on one side and a break line on the other side. Bottles of 90 with child-resistant closure NDC 68462-331-90 Bottles of 500 with child-resistant closure NDC 68462-331-05 Unit-dose pack of 100 (10 x 10) NDC 68462-331-11 0.5 mg: oval, white, flat beveled tablets engraved with ‘PX’ and ‘2’ on either side of a break line on one side and a break line on the other side. Bottles of 90 with child-resistant closure NDC 68462-332-90 Bottles of 500 with child-resistant closure NDC 68462-332-05 Unit-dose pack of 100 (10 x 10) NDC 68462-332-11 0.75 mg: oval, white, flat beveled uncoated tablets engraved with ‘PX’ and ‘5’ on one side and plain on the other side. Bottles of 90 with child-resistant closure NDC 68462-627-90 Bottles of 500 NDC 68462-627-05 1 mg: oval, white, flat beveled tablets engraved with ‘PX’ and ‘3’ on either side of a break line on one side and a break line on the other side. Bottles of 90 with child-resistant closure NDC 68462-333-90 Bottles of 500 with child-resistant closure NDC 68462-333-05 Unit-dose pack of 100 (10 x 10) NDC 68462-333-11 1.5 mg: oval, white, flat beveled tablets engraved with ‘PX’ and ‘4’ on either side of a break line on one side and a break line on the other side. Bottles of 90 with child-resistant closure NDC 68462-334-90 Bottles of 500 with child-resistant closure NDC 68462-334-05 Unit-dose pack of 100 (10 x 10) NDC 68462-334-11 16.2 Storage and Handling Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Protect from light. Store in a safe place out of the reach of children.
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