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Active ingredient

Pramipexole

137 finished FDA listings contain Pramipexole as their only active ingredient.

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FDA NDC Directory

Ingredient names as written by FDA
PRAMIPEXOLE DIHYDROCHLORIDE
Dosage forms
Tablet, Tablet, Extended Release
Routes
Oral
Manufacturers / labelers
22
Strengths listed
.125 mg/1 · .25 mg/1 · .375 mg/1 · .5 mg/1 · .75 mg/1 · 1 mg/1 · 1.5 mg/1 · 2.25 mg/1 · 3 mg/1 · 3.75 mg/1 · 4.5 mg/1
Brand names in FDA listings
Pramipexole Dihydrochloride Extended-Release

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 746741

Drugs@FDA applications

Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.

ApplicationSponsorOriginal approvalListings
ANDA 090781GLENMARK PHARMS LTD2010-10-088
ANDA 090865TORRENT PHARMS2010-10-0816
ANDA 078894ALEMBIC2010-10-0815
ANDA 202164MACLEODS PHARMS LTD2012-09-205
ANDA 202633AUROBINDO PHARMA LTD2012-10-2620
ANDA 202702STRIDES PHARMA2014-06-036
ANDA 203855SCIEGEN PHARMS2014-10-2818
ANDA 203354DR REDDYS2015-08-075
ANDA 206156MACLEODS PHARMS2016-06-2413
ANDA 207011UNICHEM2018-12-196
ANDA 204518ALEMBIC2019-01-0214
ANDA 212797XIAMEN LP PHARM CO2021-06-114
ANDA 213444NOVAST LABS2022-02-037

Official labeling on DailyMed

Showing the 12 most recent of 37 labels.

Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.