NDC 71335-1537

Pramipexole Dihydrochloride

Pramipexole Dihydrochloride

Pramipexole Dihydrochloride is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Bryant Ranch Prepack. The primary component is Pramipexole Dihydrochloride.

Product ID71335-1537_614a0c3b-547e-4f87-b7e7-ea42338a44bb
NDC71335-1537
Product TypeHuman Prescription Drug
Proprietary NamePramipexole Dihydrochloride
Generic NamePramipexole Dihydrochloride
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2012-10-26
Marketing CategoryANDA / ANDA
Application NumberANDA202633
Labeler NameBryant Ranch Prepack
Substance NamePRAMIPEXOLE DIHYDROCHLORIDE
Active Ingredient Strength0 mg/1
Pharm ClassesDopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 71335-1537-1

30 TABLET in 1 BOTTLE (71335-1537-1)
Marketing Start Date2020-03-19
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 71335-1537-1 [71335153701]

Pramipexole Dihydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA202633
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-03-19

NDC 71335-1537-2 [71335153702]

Pramipexole Dihydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA202633
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-03-19

Drug Details

NDC Crossover Matching brand name "Pramipexole Dihydrochloride" or generic name "Pramipexole Dihydrochloride"

NDCBrand NameGeneric Name
68084-793Pramipexole DihydrochloridePramipexole Dihydrochloride
68084-982Pramipexole DihydrochloridePramipexole Dihydrochloride
68084-440Pramipexole DihydrochloridePramipexole Dihydrochloride
68084-974Pramipexole DihydrochloridePramipexole Dihydrochloride
68151-3966Pramipexole DihydrochloridePramipexole Dihydrochloride
68151-0329Pramipexole DihydrochloridePramipexole Dihydrochloride
68151-3645Pramipexole DihydrochloridePramipexole Dihydrochloride
68382-196Pramipexole DihydrochloridePramipexole Dihydrochloride
68382-198Pramipexole DihydrochloridePramipexole Dihydrochloride
68382-199Pramipexole DihydrochloridePramipexole Dihydrochloride
68382-475Pramipexole DihydrochloridePramipexole Dihydrochloride
68382-200Pramipexole DihydrochloridePramipexole Dihydrochloride
68382-476Pramipexole DihydrochloridePramipexole Dihydrochloride
68382-875Pramipexole DihydrochloridePramipexole Dihydrochloride
68382-477Pramipexole DihydrochloridePramipexole Dihydrochloride
68382-197Pramipexole DihydrochloridePramipexole Dihydrochloride
68382-474Pramipexole DihydrochloridePramipexole Dihydrochloride
68382-478Pramipexole DihydrochloridePramipexole Dihydrochloride
68382-874Pramipexole DihydrochloridePramipexole Dihydrochloride
68462-627Pramipexole dihydrochloridePramipexole dihydrochloride
68462-330Pramipexole dihydrochloridePramipexole dihydrochloride
68462-332Pramipexole dihydrochloridePramipexole dihydrochloride
68462-334Pramipexole dihydrochloridePramipexole dihydrochloride
68462-333Pramipexole dihydrochloridePramipexole dihydrochloride
68462-331Pramipexole dihydrochloridePramipexole dihydrochloride
70771-1330Pramipexole DihydrochloridePramipexole Dihydrochloride
70771-1333Pramipexole DihydrochloridePramipexole Dihydrochloride
70771-1329Pramipexole DihydrochloridePramipexole Dihydrochloride
70771-1334Pramipexole DihydrochloridePramipexole Dihydrochloride
70771-1328Pramipexole DihydrochloridePramipexole Dihydrochloride
70771-1331Pramipexole DihydrochloridePramipexole Dihydrochloride
70771-1332Pramipexole DihydrochloridePramipexole Dihydrochloride
71335-0584Pramipexole DihydrochloridePramipexole Dihydrochloride
0615-7597Pramipexole DihydrochloridePramipexole Dihydrochloride
0781-5249Pramipexole DihydrochloridePramipexole Dihydrochloride
0781-5248Pramipexole DihydrochloridePramipexole Dihydrochloride
0781-5252Pramipexole DihydrochloridePramipexole Dihydrochloride
0781-5281Pramipexole DihydrochloridePramipexole Dihydrochloride
0781-5250Pramipexole DihydrochloridePramipexole Dihydrochloride
0781-5251Pramipexole DihydrochloridePramipexole Dihydrochloride
13668-095Pramipexole DihydrochloridePramipexole Dihydrochloride
13668-184Pramipexole DihydrochloridePramipexole Dihydrochloride
13668-092Pramipexole DihydrochloridePramipexole Dihydrochloride
13668-091Pramipexole DihydrochloridePramipexole Dihydrochloride
13668-094Pramipexole DihydrochloridePramipexole Dihydrochloride
13668-093Pramipexole DihydrochloridePramipexole Dihydrochloride
16714-920Pramipexole DihydrochloridePramipexole Dihydrochloride
16714-916Pramipexole DihydrochloridePramipexole Dihydrochloride
16714-922Pramipexole DihydrochloridePramipexole Dihydrochloride
16714-918Pramipexole DihydrochloridePramipexole Dihydrochloride
© 2026 FDA.report
This site is not affiliated with or endorsed by the FDA.