NDC 71034-003

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 Xiamen Lp Pharmaceutical Co., Ltd.. The primary component is Pramipexole Dihydrochloride.

Product ID71034-003_c4ddb97d-cba5-9f6b-e053-2a95a90a4956
NDC71034-003
Product TypeHuman Prescription Drug
Proprietary NamePramipexole Dihydrochloride Extended-Release
Generic NamePramipexole Dihydrochloride
Dosage FormTablet, Extended Release
Route of AdministrationORAL
Marketing Start Date2021-06-11
Marketing CategoryANDA /
Application NumberANDA212797
Labeler NameXiamen LP Pharmaceutical Co., Ltd.
Substance NamePRAMIPEXOLE DIHYDROCHLORIDE
Active Ingredient Strength1 mg/1
Pharm ClassesDopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 71034-003-30

30 TABLET, EXTENDED RELEASE in 1 BOTTLE (71034-003-30)
Marketing Start Date2021-06-11
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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