Pramipexole dihydrochloride 0.25 MG Oral Tablet
1 INDICATIONS AND USAGE Pramipexole dihydrochloride is a non-ergot dopamine agonist indicated for the treatment of: Parkinsonβs 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).
aurobindo pharma limited
OVAL WHITE Y 42
Y 42 OVAL WHITE
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16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied
PRAMIPEXOLE DIHYDROCHLORIDE tablets are available as follows:
PRAMIPEXOLE DIHYDROCHLORIDE Tablets, 0.125 mg are white to off-white, round, flat, beveled edge uncoated tablets, debossed with βYβ on one side β41β on other side. Bottles of 90 NDC 65862-604-90 Bottles of 1,000 NDC 65862-604-99 Cartons of 100 (10 x 10) Unit-dose Tablets NDC 65862-604-78
PRAMIPEXOLE DIHYDROCHLORIDE Tablets, 0.25 mg are white to off-white, oval, biconcave, beveled edge uncoated tablets, debossed with βYβ and β42β separated by score line on one side and plain with score line on other side. Bottles of 90 NDC 65862-605-90 Bottles of 1,000 NDC 65862-605-99 Cartons of 100 (10 x 10) Unit-dose Tablets NDC 65862-605-78
PRAMIPEXOLE DIHYDROCHLORIDE Tablets, 0.5 mg are white to off-white, oval, biconcave, beveled edge uncoated tablets, debossed with βYβ and β43β separated by score line on one side and plain with score line on other side. Bottles of 90 NDC 65862-606-90 Bottles of 1,000 NDC 65862-606-99 Cartons of 100 (10 x 10) Unit-dose Tablets NDC 65862-606-78
PRAMIPEXOLE DIHYDROCHLORIDE Tablets, 0.75 mg are white to off-white, oval, biconcave, beveled edge uncoated tablets, debossed with βYβ on one side and β44β on other side. Bottles of 90 NDC 65862-607-90 Bottles of 1,000 NDC 65862-607-99 Cartons of 100 (10 x 10) Unit-dose Tablets NDC 65862-607-78
PRAMIPEXOLE DIHYDROCHLORIDE Tablets, 1 mg are white to off-white, round, flat, beveled edge uncoated tablets, debossed with βYβ and β45β separated by score line on one side and plain with score line on other side. Bottles of 90 NDC 65862-608-90 Bottles of 1,000 NDC 65862-608-99 Cartons of 100 (10 x 10) Unit-dose Tablets NDC 65862-608-78
PRAMIPEXOLE DIHYDROCHLORIDE Tablets, 1.5 mg are white to off-white, round, flat, beveled edge uncoated tablets, debossed with βYβ and β46β separated by score line on one side and plain with score line on other side. Bottles of 90 NDC 65862-609-90 Bottles of 1,000 NDC 65862-609-99 Cartons of 100 (10 x 10) Unit-dose Tablets NDC 65862-609-78 16.2 Storage and Handling Store at 20Β° to 25Β°C (68Β° to 77Β°F) [see USP Controlled Room Temperature]. Protect from light. Store in a safe place out of the reach of children.
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