FDA.reportPublic FDA data

Pramipexole dihydrochloride

Product NDC
55111-615
11-digit product format
551110615
Labeler code
55111
Product ID
55111-615_4dfe5cc9-1281-c6dc-a6dc-6113fd0aed67
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pramipexole dihydrochloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Dr. Reddy's Laboratories Limited
Application
ANDA203354
Marketing category
ANDA
Marketing start
2015-08-14
Substance
PRAMIPEXOLE DIHYDROCHLORIDE
Active strength
4.5 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 DIHYDROCHLORIDE4.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3D867NP06J
Rxcui901534, 901541, 901546, 901550, 901555

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
55111-615-30Pramipexole dihydrochloride30 in 1 BOTTLETABLET, EXTENDED RELEASE3016

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55111-615-30EA - Each55111-615e2c92aa0-1aa5-4c29-9966-70cffd4b095b12015-09-10

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PRAMIPEXOLE DIHYDROCHLORIDEACTIVE INGREDIENT3D867NP06JPRAMIPEXOLE DIHYDROCHLORIDE TABLET, EXTENDED RELEASE PRAMIPEXOLE DIHYDROCHLORIDE (PRAMIPEXOLE DIHYDROCHLORIDE) TABLET, EXTENDED RELEASE [DR. REDDY'S LABORATORIES LIMITED]7
PRAMIPEXOLEACTIVE MOIETY83619PEU5TPRAMIPEXOLE DIHYDROCHLORIDE TABLET, EXTENDED RELEASE PRAMIPEXOLE DIHYDROCHLORIDE (PRAMIPEXOLE DIHYDROCHLORIDE) TABLET, EXTENDED RELEASE [DR. REDDY'S LABORATORIES LIMITED]7
CARBOMER HOMOPOLYMER TYPE AINACTIVE INGREDIENTF68VH75CJCPRAMIPEXOLE DIHYDROCHLORIDE TABLET, EXTENDED RELEASE PRAMIPEXOLE DIHYDROCHLORIDE (PRAMIPEXOLE DIHYDROCHLORIDE) TABLET, EXTENDED RELEASE [DR. REDDY'S LABORATORIES LIMITED]7
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPRAMIPEXOLE DIHYDROCHLORIDE TABLET, EXTENDED RELEASE PRAMIPEXOLE DIHYDROCHLORIDE (PRAMIPEXOLE DIHYDROCHLORIDE) TABLET, EXTENDED RELEASE [DR. REDDY'S LABORATORIES LIMITED]7
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOPRAMIPEXOLE DIHYDROCHLORIDE TABLET, EXTENDED RELEASE PRAMIPEXOLE DIHYDROCHLORIDE (PRAMIPEXOLE DIHYDROCHLORIDE) TABLET, EXTENDED RELEASE [DR. REDDY'S LABORATORIES LIMITED]7
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PRAMIPEXOLE DIHYDROCHLORIDE TABLET, EXTENDED RELEASE PRAMIPEXOLE DIHYDROCHLORIDE (PRAMIPEXOLE DIHYDROCHLORIDE) TABLET, EXTENDED RELEASE [DR. REDDY'S LABORATORIES LIMITED]7
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4PRAMIPEXOLE DIHYDROCHLORIDE TABLET, EXTENDED RELEASE PRAMIPEXOLE DIHYDROCHLORIDE (PRAMIPEXOLE DIHYDROCHLORIDE) TABLET, EXTENDED RELEASE [DR. REDDY'S LABORATORIES LIMITED]7
STARCH, PREGELATINIZED CORNINACTIVE INGREDIENTO8232NY3SJPRAMIPEXOLE DIHYDROCHLORIDE TABLET, EXTENDED RELEASE PRAMIPEXOLE DIHYDROCHLORIDE (PRAMIPEXOLE DIHYDROCHLORIDE) TABLET, EXTENDED RELEASE [DR. REDDY'S LABORATORIES LIMITED]7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55111-615PRAMIPEXOLE DIHYDROCHLORIDE TABLET, EXTENDED RELEASE PRAMIPEXOLE DIHYDROCHLORIDE (PRAMIPEXOLE DIHYDROCHLORIDE) TABLET, EXTENDED RELEASE [DR. REDDY'S LABORATORIES LIMITED]16Current NDC, Legacy NDC, 1 package rows20240829_00699692-532a-68fd-8a51-3770a81b2208.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
901541pramipexole dihydrochloride 0.375 MG 24HR Extended Release Oral TabletPSN00699692-532a-68fd-8a51-3770a81b220816
901546pramipexole dihydrochloride 0.75 MG 24HR Extended Release Oral TabletPSN00699692-532a-68fd-8a51-3770a81b220816
901550pramipexole dihydrochloride 1.5 MG 24HR Extended Release Oral TabletPSN00699692-532a-68fd-8a51-3770a81b220816
901555pramipexole dihydrochloride 3 MG 24HR Extended Release Oral TabletPSN00699692-532a-68fd-8a51-3770a81b220816
901534pramipexole dihydrochloride 4.5 MG 24HR Extended Release Oral TabletPSN00699692-532a-68fd-8a51-3770a81b220816
90154124 HR pramipexole dihydrochloride 0.375 MG Extended Release Oral TabletSCD00699692-532a-68fd-8a51-3770a81b220816
90154624 HR pramipexole dihydrochloride 0.75 MG Extended Release Oral TabletSCD00699692-532a-68fd-8a51-3770a81b220816
90155024 HR pramipexole dihydrochloride 1.5 MG Extended Release Oral TabletSCD00699692-532a-68fd-8a51-3770a81b220816
90155524 HR pramipexole dihydrochloride 3 MG Extended Release Oral TabletSCD00699692-532a-68fd-8a51-3770a81b220816
90153424 HR pramipexole dihydrochloride 4.5 MG Extended Release Oral TabletSCD00699692-532a-68fd-8a51-3770a81b220816
901541pramipexole dihydrochloride 0.375 MG 24 HR Extended Release Oral TabletSY00699692-532a-68fd-8a51-3770a81b220816
901546pramipexole dihydrochloride 0.75 MG 24 HR Extended Release Oral TabletSY00699692-532a-68fd-8a51-3770a81b220816
901550pramipexole dihydrochloride 1.5 MG 24 HR Extended Release Oral TabletSY00699692-532a-68fd-8a51-3770a81b220816
901555pramipexole dihydrochloride 3 MG 24 HR Extended Release Oral TabletSY00699692-532a-68fd-8a51-3770a81b220816
901534pramipexole dihydrochloride 4.5 MG 24 HR Extended Release Oral TabletSY00699692-532a-68fd-8a51-3770a81b220816
901546pramipexole dihydrochloride 750 MCG 24 HR Extended Release Oral TabletSY00699692-532a-68fd-8a51-3770a81b220816

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
55111-615-305511106153030 TABLET, EXTENDED RELEASE in 1 BOTTLE (55111-615-30) 2015-08-140000-00-00NoNoCurrent