FDA.reportPublic FDA data

Mirapex

Product NDC
0597-0185
11-digit product format
005970185
Labeler code
0597
Product ID
0597-0185_b530bc3b-69a8-a6a3-c79a-93714d39a718
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
0000-00-00
Substance
PRAMIPEXOLE DIHYDROCHLORIDE
Active strength
1 mg/1
Pharmacologic classes
Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC]
NDC exclude flag
No
Listing certified through
2022-12-31
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
0597-0185-61EA - Each0597-01851c9f0bdd-a45f-44b8-ac59-100c1ecf3e8c12012-07-24
0597-0185-90EA - Each0597-018544658709-2041-4819-a34d-80f10a2243c812012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
pramipexole dihydrochlorideACTIVE INGREDIENT3D867NP06JMIRAPEX (PRAMIPEXOLE DIHYDROCHLORIDE) TABLET [PHYSICIANS TOTAL CARE, INC.]1
pramipexole dihydrochlorideACTIVE INGREDIENT3D867NP06JMIRAPEX (PRAMIPEXOLE DIHYDROCHLORIDE) TABLET [REBEL DISTRIBUTORS CORP]1
pramipexoleACTIVE MOIETY83619PEU5TMIRAPEX (PRAMIPEXOLE DIHYDROCHLORIDE) TABLET [PHYSICIANS TOTAL CARE, INC.]1
pramipexoleACTIVE MOIETY83619PEU5TMIRAPEX (PRAMIPEXOLE DIHYDROCHLORIDE) TABLET [REBEL DISTRIBUTORS CORP]1
colloidal silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4MIRAPEX (PRAMIPEXOLE DIHYDROCHLORIDE) TABLET [REBEL DISTRIBUTORS CORP]1
magnesium stearateINACTIVE INGREDIENT70097M6I30MIRAPEX (PRAMIPEXOLE DIHYDROCHLORIDE) TABLET [PHYSICIANS TOTAL CARE, INC.]1
magnesium stearateINACTIVE INGREDIENT70097M6I30MIRAPEX (PRAMIPEXOLE DIHYDROCHLORIDE) TABLET [REBEL DISTRIBUTORS CORP]1
MANNITOLINACTIVE INGREDIENT3OWL53L36AMIRAPEX (PRAMIPEXOLE DIHYDROCHLORIDE) TABLET [PHYSICIANS TOTAL CARE, INC.]1
mannitolINACTIVE INGREDIENT3OWL53L36AMIRAPEX (PRAMIPEXOLE DIHYDROCHLORIDE) TABLET [REBEL DISTRIBUTORS CORP]1
povidoneINACTIVE INGREDIENTFZ989GH94EMIRAPEX (PRAMIPEXOLE DIHYDROCHLORIDE) TABLET [PHYSICIANS TOTAL CARE, INC.]1
povidoneINACTIVE INGREDIENTFZ989GH94EMIRAPEX (PRAMIPEXOLE DIHYDROCHLORIDE) TABLET [REBEL DISTRIBUTORS CORP]1
silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4MIRAPEX (PRAMIPEXOLE DIHYDROCHLORIDE) TABLET [PHYSICIANS TOTAL CARE, INC.]1
starch, cornINACTIVE INGREDIENTO8232NY3SJMIRAPEX (PRAMIPEXOLE DIHYDROCHLORIDE) TABLET [PHYSICIANS TOTAL CARE, INC.]1
starch, cornINACTIVE INGREDIENTO8232NY3SJMIRAPEX (PRAMIPEXOLE DIHYDROCHLORIDE) TABLET [REBEL DISTRIBUTORS CORP]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 TabletPSNb5504316-3907-444c-b604-ec9a18cdcd6d1
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
859044pramipexole dihydrochloride 0.5 MG Oral TabletPSNb5504316-3907-444c-b604-ec9a18cdcd6d1
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]SBDb5504316-3907-444c-b604-ec9a18cdcd6d1
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 TabletSCDb5504316-3907-444c-b604-ec9a18cdcd6d1
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 TabletSYb5504316-3907-444c-b604-ec9a18cdcd6d1
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
859044pramipexole dihydrochloride 0.5 MG (pramipexole 0.35 MG) Oral TabletSYb5504316-3907-444c-b604-ec9a18cdcd6d1
859052pramipexole dihydrochloride 1 MG (pramipexole 0.7 MG) Oral TabletSY3736d691-e8b9-4fdd-aeca-9e96cf907c511

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0597-0185-90005970185901 BOTTLE in 1 CARTON (0597-0185-90) > 90 TABLET in 1 BOTTLE1 bottle2004-01-010000-00-00NoNoCurrent