FDA.reportPublic FDA data

Pramipexole dihydrochloride

Product NDC
50742-331
11-digit product format
507420331
Labeler code
50742
Product ID
50742-331_74c3457e-079c-4b2b-bae4-3f148540a27a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pramipexole dihydrochloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Ingenus Pharmaceuticals, LLC
Application
ANDA213444
Marketing category
ANDA
Marketing start
2022-03-10
Substance
PRAMIPEXOLE DIHYDROCHLORIDE
Active strength
.375 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 DIHYDROCHLORIDE.375 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3D867NP06J
Rxcui901534, 901541, 901546, 901550, 901555, 1114479, 1114485

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
50742-331-30Pramipexole dihydrochloride30 in 1 BOTTLETABLET, EXTENDED RELEASE302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50742-331PRAMIPEXOLE DIHYDROCHLORIDE TABLET, EXTENDED RELEASE [INGENUS PHARMACEUTICALS, LLC]2Current NDC, Legacy NDC, 1 package rows20250508_1d2b1d2c-ae22-424a-bad7-ce24a817b042.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
901541pramipexole dihydrochloride 0.375 MG 24HR Extended Release Oral TabletPSN1d2b1d2c-ae22-424a-bad7-ce24a817b0422
901546pramipexole dihydrochloride 0.75 MG 24HR Extended Release Oral TabletPSN1d2b1d2c-ae22-424a-bad7-ce24a817b0422
901550pramipexole dihydrochloride 1.5 MG 24HR Extended Release Oral TabletPSN1d2b1d2c-ae22-424a-bad7-ce24a817b0422
1114479pramipexole dihydrochloride 2.25 MG 24HR Extended Release Oral TabletPSN1d2b1d2c-ae22-424a-bad7-ce24a817b0422
901555pramipexole dihydrochloride 3 MG 24HR Extended Release Oral TabletPSN1d2b1d2c-ae22-424a-bad7-ce24a817b0422
1114485pramipexole dihydrochloride 3.75 MG 24HR Extended Release Oral TabletPSN1d2b1d2c-ae22-424a-bad7-ce24a817b0422
901534pramipexole dihydrochloride 4.5 MG 24HR Extended Release Oral TabletPSN1d2b1d2c-ae22-424a-bad7-ce24a817b0422
90154124 HR pramipexole dihydrochloride 0.375 MG Extended Release Oral TabletSCD1d2b1d2c-ae22-424a-bad7-ce24a817b0422
90154624 HR pramipexole dihydrochloride 0.75 MG Extended Release Oral TabletSCD1d2b1d2c-ae22-424a-bad7-ce24a817b0422
90155024 HR pramipexole dihydrochloride 1.5 MG Extended Release Oral TabletSCD1d2b1d2c-ae22-424a-bad7-ce24a817b0422
111447924 HR pramipexole dihydrochloride 2.25 MG Extended Release Oral TabletSCD1d2b1d2c-ae22-424a-bad7-ce24a817b0422
90155524 HR pramipexole dihydrochloride 3 MG Extended Release Oral TabletSCD1d2b1d2c-ae22-424a-bad7-ce24a817b0422
111448524 HR pramipexole dihydrochloride 3.75 MG Extended Release Oral TabletSCD1d2b1d2c-ae22-424a-bad7-ce24a817b0422
90153424 HR pramipexole dihydrochloride 4.5 MG Extended Release Oral TabletSCD1d2b1d2c-ae22-424a-bad7-ce24a817b0422
901541pramipexole dihydrochloride 0.375 MG 24 HR Extended Release Oral TabletSY1d2b1d2c-ae22-424a-bad7-ce24a817b0422
901546pramipexole dihydrochloride 0.75 MG 24 HR Extended Release Oral TabletSY1d2b1d2c-ae22-424a-bad7-ce24a817b0422
901550pramipexole dihydrochloride 1.5 MG 24 HR Extended Release Oral TabletSY1d2b1d2c-ae22-424a-bad7-ce24a817b0422
1114479pramipexole dihydrochloride 2.25 MG 24 HR Extended Release Oral TabletSY1d2b1d2c-ae22-424a-bad7-ce24a817b0422
901555pramipexole dihydrochloride 3 MG 24 HR Extended Release Oral TabletSY1d2b1d2c-ae22-424a-bad7-ce24a817b0422
1114485pramipexole dihydrochloride 3.75 MG 24 HR Extended Release Oral TabletSY1d2b1d2c-ae22-424a-bad7-ce24a817b0422
901534pramipexole dihydrochloride 4.5 MG 24 HR Extended Release Oral TabletSY1d2b1d2c-ae22-424a-bad7-ce24a817b0422
901546pramipexole dihydrochloride 750 MCG 24 HR Extended Release Oral TabletSY1d2b1d2c-ae22-424a-bad7-ce24a817b0422

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50742-331-305074203313030 TABLET, EXTENDED RELEASE in 1 BOTTLE (50742-331-30) 2022-03-100000-00-00NoNoCurrent