FDA.reportPublic FDA data

Pramipexole Dihydrochloride

Product NDC
16714-920
11-digit product format
167140920
Labeler code
16714
Product ID
16714-920_b78c4a9c-3ad8-443e-ada5-853385411cfc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pramipexole Dihydrochloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
NorthStar RxLLC
Application
ANDA206156
Marketing category
ANDA
Marketing start
2019-03-06
Substance
PRAMIPEXOLE DIHYDROCHLORIDE
Active strength
3 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 DIHYDROCHLORIDE3 mg/1

Harmonized Identifiers#

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

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
16714-920-01Pramipexole Dihydrochloride30 in 1 BOTTLETABLET, EXTENDED RELEASE306

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16714-920-01EA - Each16714-920815d9e93-883c-46cf-88c1-1724ba0bccfe12019-04-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16714-920PRAMIPEXOLE DIHYDROCHLORIDE TABLET, EXTENDED RELEASE [NORTHSTAR RXLLC]6Current NDC, Legacy NDC, 1 package rows20240824_946c8a72-8c48-4925-93d3-7940f4c0fd29.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
901541pramipexole dihydrochloride 0.375 MG 24HR Extended Release Oral TabletPSN946c8a72-8c48-4925-93d3-7940f4c0fd296
901546pramipexole dihydrochloride 0.75 MG 24HR Extended Release Oral TabletPSN946c8a72-8c48-4925-93d3-7940f4c0fd296
901550pramipexole dihydrochloride 1.5 MG 24HR Extended Release Oral TabletPSN946c8a72-8c48-4925-93d3-7940f4c0fd296
1114479pramipexole dihydrochloride 2.25 MG 24HR Extended Release Oral TabletPSN946c8a72-8c48-4925-93d3-7940f4c0fd296
901555pramipexole dihydrochloride 3 MG 24HR Extended Release Oral TabletPSN946c8a72-8c48-4925-93d3-7940f4c0fd296
901534pramipexole dihydrochloride 4.5 MG 24HR Extended Release Oral TabletPSN946c8a72-8c48-4925-93d3-7940f4c0fd296
90154124 HR pramipexole dihydrochloride 0.375 MG Extended Release Oral TabletSCD946c8a72-8c48-4925-93d3-7940f4c0fd296
90154624 HR pramipexole dihydrochloride 0.75 MG Extended Release Oral TabletSCD946c8a72-8c48-4925-93d3-7940f4c0fd296
90155024 HR pramipexole dihydrochloride 1.5 MG Extended Release Oral TabletSCD946c8a72-8c48-4925-93d3-7940f4c0fd296
111447924 HR pramipexole dihydrochloride 2.25 MG Extended Release Oral TabletSCD946c8a72-8c48-4925-93d3-7940f4c0fd296
90155524 HR pramipexole dihydrochloride 3 MG Extended Release Oral TabletSCD946c8a72-8c48-4925-93d3-7940f4c0fd296
90153424 HR pramipexole dihydrochloride 4.5 MG Extended Release Oral TabletSCD946c8a72-8c48-4925-93d3-7940f4c0fd296
901541pramipexole dihydrochloride 0.375 MG 24 HR Extended Release Oral TabletSY946c8a72-8c48-4925-93d3-7940f4c0fd296
901546pramipexole dihydrochloride 0.75 MG 24 HR Extended Release Oral TabletSY946c8a72-8c48-4925-93d3-7940f4c0fd296
901550pramipexole dihydrochloride 1.5 MG 24 HR Extended Release Oral TabletSY946c8a72-8c48-4925-93d3-7940f4c0fd296
1114479pramipexole dihydrochloride 2.25 MG 24 HR Extended Release Oral TabletSY946c8a72-8c48-4925-93d3-7940f4c0fd296
901555pramipexole dihydrochloride 3 MG 24 HR Extended Release Oral TabletSY946c8a72-8c48-4925-93d3-7940f4c0fd296
901534pramipexole dihydrochloride 4.5 MG 24 HR Extended Release Oral TabletSY946c8a72-8c48-4925-93d3-7940f4c0fd296
901546pramipexole dihydrochloride 750 MCG 24 HR Extended Release Oral TabletSY946c8a72-8c48-4925-93d3-7940f4c0fd296

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
16714-920-011671409200130 TABLET, EXTENDED RELEASE in 1 BOTTLE (16714-920-01) 2019-03-060000-00-00NoNoCurrent