Pramipexole Dihydrochloride

Product NDC
62332-006
11-digit product format
623320006
Labeler code
62332
Product ID
62332-006_2cfde57a-499e-477a-8e1a-63dca99203f2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pramipexole Dihydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Alembic Pharmaceuticals Inc.
Application
ANDA078894
Marketing category
ANDA
Marketing start
2016-03-22
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
62332-006-90Pramipexole Dihydrochloride90 in 1 BOTTLETABLET9012

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62332-006PRAMIPEXOLE DIHYDROCHLORIDE TABLET [ALEMBIC PHARMACEUTICALS INC.]10Current NDC, Legacy NDC, 1 package rows20230308_4fe7106d-4bf6-4794-87cb-8df616994c41.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
859033pramipexole dihydrochloride 0.125 MG Oral TabletPSN4fe7106d-4bf6-4794-87cb-8df616994c4112
859040pramipexole dihydrochloride 0.25 MG Oral TabletPSN4fe7106d-4bf6-4794-87cb-8df616994c4112
859044pramipexole dihydrochloride 0.5 MG Oral TabletPSN4fe7106d-4bf6-4794-87cb-8df616994c4112
859052pramipexole dihydrochloride 1 MG Oral TabletPSN4fe7106d-4bf6-4794-87cb-8df616994c4112
859048pramipexole dihydrochloride 1.5 MG Oral TabletPSN4fe7106d-4bf6-4794-87cb-8df616994c4112
859033pramipexole dihydrochloride 0.125 MG Oral TabletSCD4fe7106d-4bf6-4794-87cb-8df616994c4112
859040pramipexole dihydrochloride 0.25 MG Oral TabletSCD4fe7106d-4bf6-4794-87cb-8df616994c4112
859044pramipexole dihydrochloride 0.5 MG Oral TabletSCD4fe7106d-4bf6-4794-87cb-8df616994c4112
859052pramipexole dihydrochloride 1 MG Oral TabletSCD4fe7106d-4bf6-4794-87cb-8df616994c4112
859048pramipexole dihydrochloride 1.5 MG Oral TabletSCD4fe7106d-4bf6-4794-87cb-8df616994c4112
859033pramipexole dihydrochloride 0.125 MG (pramipexole 0.088 MG) Oral TabletSY4fe7106d-4bf6-4794-87cb-8df616994c4112
859040pramipexole dihydrochloride 0.25 MG (pramipexole 0.18 MG) Oral TabletSY4fe7106d-4bf6-4794-87cb-8df616994c4112
859044pramipexole dihydrochloride 0.5 MG (pramipexole 0.35 MG) Oral TabletSY4fe7106d-4bf6-4794-87cb-8df616994c4112
859052pramipexole dihydrochloride 1 MG (pramipexole 0.7 MG) Oral TabletSY4fe7106d-4bf6-4794-87cb-8df616994c4112
859048pramipexole dihydrochloride 1.5 MG (equivalent to pramipexole 1 MG) Oral TabletSY4fe7106d-4bf6-4794-87cb-8df616994c4112

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62332-006-906233200069090 TABLET in 1 BOTTLE (62332-006-90) 90 tablet2016-03-220000-00-00NoNoCurrent