NDC 69680-145

Pramipexole Dihydrochloride Extended-Release

Pramipexole Dihydrochloride

Pramipexole Dihydrochloride Extended-Release is a Oral Tablet, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Vitruvias Therapeutics, Inc.. The primary component is Pramipexole Dihydrochloride.

Product ID69680-145_041fc17f-6071-4943-8282-30da3860f5fb
NDC69680-145
Product TypeHuman Prescription Drug
Proprietary NamePramipexole Dihydrochloride Extended-Release
Generic NamePramipexole Dihydrochloride
Dosage FormTablet, Extended Release
Route of AdministrationORAL
Marketing Start Date2021-08-27
Marketing CategoryANDA /
Application NumberANDA212797
Labeler NameVitruvias Therapeutics, Inc.
Substance NamePRAMIPEXOLE DIHYDROCHLORIDE
Active Ingredient Strength0 mg/1
Pharm ClassesDopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 69680-145-30

30 TABLET, EXTENDED RELEASE in 1 BOTTLE (69680-145-30)
Marketing Start Date2021-08-27
NDC Exclude FlagN
Sample Package?N

Drug Details

NDC Crossover Matching brand name "Pramipexole Dihydrochloride Extended-Release" or generic name "Pramipexole Dihydrochloride"

NDCBrand NameGeneric Name
10370-253Pramipexole Dihydrochloride Extended-ReleasePramipexole Dihydrochloride Extended-Release
10370-252Pramipexole Dihydrochloride Extended-ReleasePramipexole Dihydrochloride Extended-Release
10370-251Pramipexole Dihydrochloride Extended-ReleasePramipexole Dihydrochloride Extended-Release
10370-306Pramipexole Dihydrochloride Extended-ReleasePramipexole Dihydrochloride Extended-Release
10370-254Pramipexole Dihydrochloride Extended-ReleasePramipexole Dihydrochloride Extended-Release
10370-255Pramipexole Dihydrochloride Extended-ReleasePramipexole Dihydrochloride Extended-Release
10370-305Pramipexole Dihydrochloride Extended-ReleasePramipexole Dihydrochloride Extended-Release
42291-557Pramipexole Dihydrochloride Extended-ReleasePramipexole Dihydrochloride Extended-Release
0597-0101Mirapexpramipexole dihydrochloride
0597-0109Mirapexpramipexole dihydrochloride
0597-0113Mirapexpramipexole dihydrochloride
0597-0115Mirapexpramipexole dihydrochloride
0597-0116Mirapexpramipexole dihydrochloride
0597-0183Mirapexpramipexole dihydrochloride
0597-0184Mirapexpramipexole dihydrochloride
0597-0185Mirapexpramipexole dihydrochloride
0597-0190Mirapexpramipexole dihydrochloride
0597-0191Mirapexpramipexole dihydrochloride
0597-0285Mirapexpramipexole dihydrochloride
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