FDA.reportPublic FDA data

Pramipexole dihydrochloride

Product NDC
33342-034
11-digit product format
333420034
Labeler code
33342
Product ID
33342-034_721c81fc-fd21-4d86-ab96-9a329b8e015b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pramipexole dihydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Macleods Pharmaceuticals Limited
Application
ANDA202164
Marketing category
ANDA
Marketing start
2012-09-21
Substance
PRAMIPEXOLE DIHYDROCHLORIDE
Active strength
1 mg/1
Pharmacologic classes
Dopamine Agonists [MoA], Nonergot Dopamine Agonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Pramipexole dihydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PRAMIPEXOLE DIHYDROCHLORIDE1 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3D867NP06J
Rxcui859033, 859040, 859044, 859048, 859052

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a67b8488-0225-64b1-be81-5cbe60d285a5Product name920221116
3863aae0-7028-3427-389e-3f6c8692e587Product name320190117

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
33342-034-06Pramipexole dihydrochloride1 in 1 BLISTER PACKTABLET110
33342-034-06Pramipexole dihydrochloride30 in 1 CARTONTABLET3010
33342-034-10Pramipexole dihydrochloride90 in 1 BOTTLETABLET9010
33342-034-12Pramipexole dihydrochloride1 in 1 BLISTER PACKTABLET110
33342-034-12Pramipexole dihydrochloride100 in 1 CARTONTABLET10010
33342-034-15Pramipexole dihydrochloride500 in 1 BOTTLETABLET50010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33342-034-10EA - Each33342-034eabd0c08-69ed-4d85-bae5-4645a537d1fc12013-08-02
33342-034-15EA - Each33342-034f31dd290-0fca-400b-8456-c4d0395b0a1412015-06-09

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PRAMIPEXOLE DIHYDROCHLORIDEACTIVE INGREDIENT3D867NP06JPRAMIPEXOLE DIHYDROCHLORIDE TABLET [MACLEODS PHARMACEUTICALS LIMITED]4
PRAMIPEXOLEACTIVE MOIETY83619PEU5TPRAMIPEXOLE DIHYDROCHLORIDE TABLET [MACLEODS PHARMACEUTICALS LIMITED]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PRAMIPEXOLE DIHYDROCHLORIDE TABLET [MACLEODS PHARMACEUTICALS LIMITED]4
MANNITOLINACTIVE INGREDIENT3OWL53L36APRAMIPEXOLE DIHYDROCHLORIDE TABLET [MACLEODS PHARMACEUTICALS LIMITED]4
POVIDONE K25INACTIVE INGREDIENTK0KQV10C35PRAMIPEXOLE DIHYDROCHLORIDE TABLET [MACLEODS PHARMACEUTICALS LIMITED]4
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4PRAMIPEXOLE DIHYDROCHLORIDE TABLET [MACLEODS PHARMACEUTICALS LIMITED]4
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJPRAMIPEXOLE DIHYDROCHLORIDE TABLET [MACLEODS PHARMACEUTICALS LIMITED]4

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
859033pramipexole dihydrochloride 0.125 MG Oral TabletPSNb8c94917-73a1-44c2-8fd8-07f45054176b10
859040pramipexole dihydrochloride 0.25 MG Oral TabletPSNb8c94917-73a1-44c2-8fd8-07f45054176b10
859044pramipexole dihydrochloride 0.5 MG Oral TabletPSNb8c94917-73a1-44c2-8fd8-07f45054176b10
859052pramipexole dihydrochloride 1 MG Oral TabletPSNb8c94917-73a1-44c2-8fd8-07f45054176b10
859048pramipexole dihydrochloride 1.5 MG Oral TabletPSNb8c94917-73a1-44c2-8fd8-07f45054176b10
859033pramipexole dihydrochloride 0.125 MG Oral TabletSCDb8c94917-73a1-44c2-8fd8-07f45054176b10
859040pramipexole dihydrochloride 0.25 MG Oral TabletSCDb8c94917-73a1-44c2-8fd8-07f45054176b10
859044pramipexole dihydrochloride 0.5 MG Oral TabletSCDb8c94917-73a1-44c2-8fd8-07f45054176b10
859052pramipexole dihydrochloride 1 MG Oral TabletSCDb8c94917-73a1-44c2-8fd8-07f45054176b10
859048pramipexole dihydrochloride 1.5 MG Oral TabletSCDb8c94917-73a1-44c2-8fd8-07f45054176b10
859033pramipexole dihydrochloride 0.125 MG (pramipexole 0.088 MG) Oral TabletSYb8c94917-73a1-44c2-8fd8-07f45054176b10
859040pramipexole dihydrochloride 0.25 MG (pramipexole 0.18 MG) Oral TabletSYb8c94917-73a1-44c2-8fd8-07f45054176b10
859044pramipexole dihydrochloride 0.5 MG (pramipexole 0.35 MG) Oral TabletSYb8c94917-73a1-44c2-8fd8-07f45054176b10
859052pramipexole dihydrochloride 1 MG (pramipexole 0.7 MG) Oral TabletSYb8c94917-73a1-44c2-8fd8-07f45054176b10
859048pramipexole dihydrochloride 1.5 MG (equivalent to pramipexole 1 MG) Oral TabletSYb8c94917-73a1-44c2-8fd8-07f45054176b10
859052pramipexole dihydrochloride 1 MG Oral TabletPSN5d7c2fc2-279c-4723-b4ec-640220f2740e3
859052pramipexole dihydrochloride 1 MG Oral TabletSCD5d7c2fc2-279c-4723-b4ec-640220f2740e3
859052pramipexole dihydrochloride 1 MG (pramipexole 0.7 MG) Oral TabletSY5d7c2fc2-279c-4723-b4ec-640220f2740e3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
33342-034-063334200340630 BLISTER PACK in 1 CARTON (33342-034-06) / 1 TABLET in 1 BLISTER PACK30 blister pack2012-09-21NoNoHistorical
33342-034-103334200341090 TABLET in 1 BOTTLE (33342-034-10) 90 tablet2012-09-21NoNoHistorical
33342-034-1233342003412100 BLISTER PACK in 1 CARTON (33342-034-12) / 1 TABLET in 1 BLISTER PACK100 blister pack2012-09-21NoNoHistorical
33342-034-1533342003415500 TABLET in 1 BOTTLE (33342-034-15) 500 tablet2012-09-21NoNoHistorical