FDA.reportPublic FDA data

Mirapex

Product NDC
0597-0184
11-digit product format
005970184
Labeler code
0597
Product ID
0597-0184_e99f9ded-c982-e585-b81a-d0a8fa1b9927
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
pramipexole dihydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Boehringer Ingelheim Pharmaceuticals, Inc.
Application
NDA020667
Marketing category
NDA
Marketing start
2004-01-01
Marketing end
2020-03-31
Substance
PRAMIPEXOLE DIHYDROCHLORIDE
Active strength
0 mg/1
Pharmacologic classes
Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC]
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a67b8488-0225-64b1-be81-5cbe60d285a5Product name920221116
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
3863aae0-7028-3427-389e-3f6c8692e587Product name320190117
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0597-0184-61EA - Each0597-0184a523eecb-b1f0-4316-99f3-112d2a96e49c12012-07-24
0597-0184-90EA - Each0597-018450ad06be-e199-4168-b89f-63c066980b8312012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
pramipexole dihydrochlorideACTIVE INGREDIENT3D867NP06JMIRAPEX (PRAMIPEXOLE DIHYDROCHLORIDE) TABLET [PHYSICIANS TOTAL CARE, INC.]1
pramipexoleACTIVE MOIETY83619PEU5TMIRAPEX (PRAMIPEXOLE DIHYDROCHLORIDE) TABLET [PHYSICIANS TOTAL CARE, INC.]1
magnesium stearateINACTIVE INGREDIENT70097M6I30MIRAPEX (PRAMIPEXOLE DIHYDROCHLORIDE) TABLET [PHYSICIANS TOTAL CARE, INC.]1
MANNITOLINACTIVE INGREDIENT3OWL53L36AMIRAPEX (PRAMIPEXOLE DIHYDROCHLORIDE) TABLET [PHYSICIANS TOTAL CARE, INC.]1
povidoneINACTIVE INGREDIENTFZ989GH94EMIRAPEX (PRAMIPEXOLE DIHYDROCHLORIDE) TABLET [PHYSICIANS TOTAL CARE, INC.]1
silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4MIRAPEX (PRAMIPEXOLE DIHYDROCHLORIDE) TABLET [PHYSICIANS TOTAL CARE, INC.]1
starch, cornINACTIVE INGREDIENTO8232NY3SJMIRAPEX (PRAMIPEXOLE DIHYDROCHLORIDE) TABLET [PHYSICIANS TOTAL CARE, INC.]1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
859035Mirapex 0.125 MG Oral TabletPSN3736d691-e8b9-4fdd-aeca-9e96cf907c511
859042Mirapex 0.25 MG Oral TabletPSN3736d691-e8b9-4fdd-aeca-9e96cf907c511
859046Mirapex 0.5 MG Oral TabletPSN3736d691-e8b9-4fdd-aeca-9e96cf907c511
859054Mirapex 1 MG Oral TabletPSN3736d691-e8b9-4fdd-aeca-9e96cf907c511
859033pramipexole dihydrochloride 0.125 MG Oral TabletPSN3736d691-e8b9-4fdd-aeca-9e96cf907c511
859040pramipexole dihydrochloride 0.25 MG Oral TabletPSN3736d691-e8b9-4fdd-aeca-9e96cf907c511
859044pramipexole dihydrochloride 0.5 MG Oral TabletPSN3736d691-e8b9-4fdd-aeca-9e96cf907c511
859052pramipexole dihydrochloride 1 MG Oral TabletPSN3736d691-e8b9-4fdd-aeca-9e96cf907c511
859035pramipexole dihydrochloride 0.125 MG Oral Tablet [Mirapex]SBD3736d691-e8b9-4fdd-aeca-9e96cf907c511
859042pramipexole dihydrochloride 0.25 MG Oral Tablet [Mirapex]SBD3736d691-e8b9-4fdd-aeca-9e96cf907c511
859046pramipexole dihydrochloride 0.5 MG Oral Tablet [Mirapex]SBD3736d691-e8b9-4fdd-aeca-9e96cf907c511
859054pramipexole dihydrochloride 1 MG Oral Tablet [Mirapex]SBD3736d691-e8b9-4fdd-aeca-9e96cf907c511
859033pramipexole dihydrochloride 0.125 MG Oral TabletSCD3736d691-e8b9-4fdd-aeca-9e96cf907c511
859040pramipexole dihydrochloride 0.25 MG Oral TabletSCD3736d691-e8b9-4fdd-aeca-9e96cf907c511
859044pramipexole dihydrochloride 0.5 MG Oral TabletSCD3736d691-e8b9-4fdd-aeca-9e96cf907c511
859052pramipexole dihydrochloride 1 MG Oral TabletSCD3736d691-e8b9-4fdd-aeca-9e96cf907c511
859035Mirapex 0.125 MG Oral TabletSY3736d691-e8b9-4fdd-aeca-9e96cf907c511
859042Mirapex 0.25 MG Oral TabletSY3736d691-e8b9-4fdd-aeca-9e96cf907c511
859046Mirapex 0.5 MG Oral TabletSY3736d691-e8b9-4fdd-aeca-9e96cf907c511
859054Mirapex 1 MG Oral TabletSY3736d691-e8b9-4fdd-aeca-9e96cf907c511
859033pramipexole dihydrochloride 0.125 MG (pramipexole 0.088 MG) Oral TabletSY3736d691-e8b9-4fdd-aeca-9e96cf907c511
859040pramipexole dihydrochloride 0.25 MG (pramipexole 0.18 MG) Oral TabletSY3736d691-e8b9-4fdd-aeca-9e96cf907c511
859044pramipexole dihydrochloride 0.5 MG (pramipexole 0.35 MG) Oral TabletSY3736d691-e8b9-4fdd-aeca-9e96cf907c511
859052pramipexole dihydrochloride 1 MG (pramipexole 0.7 MG) Oral TabletSY3736d691-e8b9-4fdd-aeca-9e96cf907c511