FDA.reportPublic FDA data

Pramipexole Dihydrochloride

Product NDC
13668-095
11-digit product format
136680095
Labeler code
13668
Product ID
13668-095_f3214c59-f86f-47d6-9ddb-0af985d11a6c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pramipexole Dihydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Torrent Pharmaceuticals Limited
Application
ANDA090865
Marketing category
ANDA
Marketing start
2010-10-08
Substance
PRAMIPEXOLE DIHYDROCHLORIDE
Active strength
1.5 mg/1
Pharmacologic classes
Dopamine Agonists [MoA], Nonergot Dopamine Agonist [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Pramipexole Dihydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PRAMIPEXOLE DIHYDROCHLORIDE1.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3D867NP06J
Rxcui858625, 859033, 859040, 859044, 859048, 859052

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 Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
13668-095-05Pramipexole Dihydrochloride500 in 1 BOTTLETABLET50022
13668-095-15Pramipexole Dihydrochloride1500 in 1 BOTTLETABLET150022
13668-095-30Pramipexole Dihydrochloride30 in 1 BOTTLETABLET3022
13668-095-90Pramipexole Dihydrochloride90 in 1 BOTTLETABLET9022

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
13668-095-05EA - Each13668-095ff09068c-9bdb-4ad3-93ff-83bcfb7e50bb12012-07-24
13668-095-90EA - Each13668-09573ba338e-1352-4332-881b-806a37ec460212012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PRAMIPEXOLE DIHYDROCHLORIDEACTIVE INGREDIENT3D867NP06JPRAMIPEXOLE DIHYDROCHLORIDE TABLET [TORRENT PHARMACEUTICALS LIMITED]7
PRAMIPEXOLEACTIVE MOIETY83619PEU5TPRAMIPEXOLE DIHYDROCHLORIDE TABLET [TORRENT PHARMACEUTICALS LIMITED]7
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4PRAMIPEXOLE DIHYDROCHLORIDE TABLET [TORRENT PHARMACEUTICALS LIMITED]7
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675PRAMIPEXOLE DIHYDROCHLORIDE TABLET [TORRENT PHARMACEUTICALS LIMITED]7
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTPRAMIPEXOLE DIHYDROCHLORIDE TABLET [TORRENT PHARMACEUTICALS LIMITED]7
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PRAMIPEXOLE DIHYDROCHLORIDE TABLET [TORRENT PHARMACEUTICALS LIMITED]7
MANNITOLINACTIVE INGREDIENT3OWL53L36APRAMIPEXOLE DIHYDROCHLORIDE TABLET [TORRENT PHARMACEUTICALS LIMITED]7
POVIDONE K30INACTIVE INGREDIENTU725QWY32XPRAMIPEXOLE DIHYDROCHLORIDE TABLET [TORRENT PHARMACEUTICALS LIMITED]7
STARCH, PREGELATINIZED CORNINACTIVE INGREDIENTO8232NY3SJPRAMIPEXOLE DIHYDROCHLORIDE TABLET [TORRENT PHARMACEUTICALS LIMITED]7
PRAMIPEXOLE DIHYDROCHLORIDEACTIVE INGREDIENT3D867NP06JPRAMIPEXOLE DIHYDROCHLORIDE TABLET [CARILION MATERIALS MANAGEMENT]2
PRAMIPEXOLEACTIVE MOIETY83619PEU5TPRAMIPEXOLE DIHYDROCHLORIDE TABLET [CARILION MATERIALS MANAGEMENT]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PRAMIPEXOLE DIHYDROCHLORIDE TABLET [CARILION MATERIALS MANAGEMENT]2
MANNITOLINACTIVE INGREDIENT3OWL53L36APRAMIPEXOLE DIHYDROCHLORIDE TABLET [CARILION MATERIALS MANAGEMENT]2
POVIDONE K30INACTIVE INGREDIENTU725QWY32XPRAMIPEXOLE DIHYDROCHLORIDE TABLET [CARILION MATERIALS MANAGEMENT]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4PRAMIPEXOLE DIHYDROCHLORIDE TABLET [CARILION MATERIALS MANAGEMENT]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJPRAMIPEXOLE DIHYDROCHLORIDE TABLET [CARILION MATERIALS MANAGEMENT]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13668-095PRAMIPEXOLE DIHYDROCHLORIDE TABLET [TORRENT PHARMACEUTICALS LIMITED]20Current NDC, Legacy NDC, 4 package rows20240816_60167d7c-469f-455a-a113-561841af5e59.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
859033pramipexole dihydrochloride 0.125 MG Oral TabletPSN60167d7c-469f-455a-a113-561841af5e5922
859040pramipexole dihydrochloride 0.25 MG Oral TabletPSN60167d7c-469f-455a-a113-561841af5e5922
859044pramipexole dihydrochloride 0.5 MG Oral TabletPSN60167d7c-469f-455a-a113-561841af5e5922
858625pramipexole dihydrochloride 0.75 MG Oral TabletPSN60167d7c-469f-455a-a113-561841af5e5922
859052pramipexole dihydrochloride 1 MG Oral TabletPSN60167d7c-469f-455a-a113-561841af5e5922
859048pramipexole dihydrochloride 1.5 MG Oral TabletPSN60167d7c-469f-455a-a113-561841af5e5922
859033pramipexole dihydrochloride 0.125 MG Oral TabletSCD60167d7c-469f-455a-a113-561841af5e5922
859040pramipexole dihydrochloride 0.25 MG Oral TabletSCD60167d7c-469f-455a-a113-561841af5e5922
859044pramipexole dihydrochloride 0.5 MG Oral TabletSCD60167d7c-469f-455a-a113-561841af5e5922
858625pramipexole dihydrochloride 0.75 MG Oral TabletSCD60167d7c-469f-455a-a113-561841af5e5922
859052pramipexole dihydrochloride 1 MG Oral TabletSCD60167d7c-469f-455a-a113-561841af5e5922
859048pramipexole dihydrochloride 1.5 MG Oral TabletSCD60167d7c-469f-455a-a113-561841af5e5922
859033pramipexole dihydrochloride 0.125 MG (pramipexole 0.088 MG) Oral TabletSY60167d7c-469f-455a-a113-561841af5e5922
859040pramipexole dihydrochloride 0.25 MG (pramipexole 0.18 MG) Oral TabletSY60167d7c-469f-455a-a113-561841af5e5922
859044pramipexole dihydrochloride 0.5 MG (pramipexole 0.35 MG) Oral TabletSY60167d7c-469f-455a-a113-561841af5e5922
858625pramipexole dihydrochloride 0.75 MG (pramipexole 0.525 MG) Oral TabletSY60167d7c-469f-455a-a113-561841af5e5922
859052pramipexole dihydrochloride 1 MG (pramipexole 0.7 MG) Oral TabletSY60167d7c-469f-455a-a113-561841af5e5922
859048pramipexole dihydrochloride 1.5 MG (equivalent to pramipexole 1 MG) Oral TabletSY60167d7c-469f-455a-a113-561841af5e5922
859048pramipexole dihydrochloride 1.5 MG Oral TabletPSN1a31f05c-9b05-4701-a49f-ecc0c75dcd5e3
859048pramipexole dihydrochloride 1.5 MG Oral TabletSCD1a31f05c-9b05-4701-a49f-ecc0c75dcd5e3
859048pramipexole dihydrochloride 1.5 MG (equivalent to pramipexole 1 MG) Oral TabletSY1a31f05c-9b05-4701-a49f-ecc0c75dcd5e3
859048pramipexole dihydrochloride 1.5 MG Oral TabletPSN3db0613d-524b-4b33-9a07-602f84d6c3042
859048pramipexole dihydrochloride 1.5 MG Oral TabletSCD3db0613d-524b-4b33-9a07-602f84d6c3042
859048pramipexole dihydrochloride 1.5 MG (equivalent to pramipexole 1 MG) Oral TabletSY3db0613d-524b-4b33-9a07-602f84d6c3042

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
13668-095-0513668009505500 TABLET in 1 BOTTLE (13668-095-05) 500 tablet2010-10-080000-00-00NoNoCurrent
13668-095-15136680095151500 TABLET in 1 BOTTLE (13668-095-15) 1500 tablet2010-10-080000-00-00NoNoCurrent
13668-095-301366800953030 TABLET in 1 BOTTLE (13668-095-30) 30 tablet2010-10-080000-00-00NoNoCurrent
13668-095-7413668009574100 TABLET in 1 CARTON (13668-095-74) 100 tablet2010-10-080000-00-00NoNoCurrent
13668-095-901366800959090 TABLET in 1 BOTTLE (13668-095-90) 90 tablet2010-10-080000-00-00NoNoCurrent