FDA.reportPublic FDA data

Pramipexole Dihydrochloride

Product NDC
71034-003
11-digit product format
710340003
Labeler code
71034
Product ID
71034-003_c4ddb97d-cba5-9f6b-e053-2a95a90a4956
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pramipexole Dihydrochloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Xiamen LP Pharmaceutical Co., Ltd.
Application
ANDA212797
Marketing category
ANDA
Marketing start
2021-06-11
Substance
PRAMIPEXOLE DIHYDROCHLORIDE
Active strength
.75 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
Brand name suffix
Extended-Release
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PRAMIPEXOLE DIHYDROCHLORIDE.75 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3D867NP06J
Rxcui901541, 901546

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
71034-003-30Pramipexole DihydrochlorideExtended-Release30 in 1 BOTTLETABLET, EXTENDED RELEASE301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71034-003PRAMIPEXOLE DIHYDROCHLORIDE EXTENDED-RELEASE (PRAMIPEXOLE DIHYDROCHLORIDE) TABLET, EXTENDED RELEASE [XIAMEN LP PHARMACEUTICAL CO., LTD.]1Current NDC, Legacy NDC, 1 package rows20210617_1cbd8ddf-4fc1-4cd0-906d-a55a4b8b1c3c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
901541pramipexole dihydrochloride 0.375 MG 24HR Extended Release Oral TabletPSN1cbd8ddf-4fc1-4cd0-906d-a55a4b8b1c3c1
901546pramipexole dihydrochloride 0.75 MG 24HR Extended Release Oral TabletPSN1cbd8ddf-4fc1-4cd0-906d-a55a4b8b1c3c1
90154124 HR pramipexole dihydrochloride 0.375 MG Extended Release Oral TabletSCD1cbd8ddf-4fc1-4cd0-906d-a55a4b8b1c3c1
90154624 HR pramipexole dihydrochloride 0.75 MG Extended Release Oral TabletSCD1cbd8ddf-4fc1-4cd0-906d-a55a4b8b1c3c1
901541pramipexole dihydrochloride 0.375 MG 24 HR Extended Release Oral TabletSY1cbd8ddf-4fc1-4cd0-906d-a55a4b8b1c3c1
901546pramipexole dihydrochloride 0.75 MG 24 HR Extended Release Oral TabletSY1cbd8ddf-4fc1-4cd0-906d-a55a4b8b1c3c1
901546pramipexole dihydrochloride 750 MCG 24 HR Extended Release Oral TabletSY1cbd8ddf-4fc1-4cd0-906d-a55a4b8b1c3c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71034-003-307103400033030 TABLET, EXTENDED RELEASE in 1 BOTTLE (71034-003-30) 2021-06-110000-00-00NoNoCurrent