Clinical Trials

Find trials by condition, location & phase

Drug Monographs

Browse drug monographs and information

Explore organizations and their profiles

Latest updates on trials and healthcare

Approved products by global authorities

AI-Powered Research

Discover powerful insights with advanced AI analysis tools for clinical trials.

Premium Access

Get unlimited access to our comprehensive pharmaceutical database and analytics.

FDA Approval

Pramipexole Dihydrochloride

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company

Alembic Pharmaceuticals Limited

DUNS: 650574663

Effective Date

November 20, 2017

Labeling Type

Human Prescription Drug Label

Active Ingredients

Pramipexole(0.125 mg in 1 1)

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

Alembic Pharmaceutical Limited (Formulation Division)

Labeler

Alembic Pharmaceuticals Limited

DUNS Number

650574671

Products5

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Pramipexole Dihydrochloride

Product Details

NDC Product Code

46708-003

Application Number

ANDA078894

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

November 20, 2017

Ingredients

BETADEXInactive

Code: JV039JZZ3AClass: IACT

PramipexoleActive

Code: 3D867NP06JClass: ACTIBQuantity: 0.125 mg in 1 1

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61UClass: IACT

POVIDONE K30Inactive

Code: U725QWY32XClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

Pramipexole Dihydrochloride

Product Details

NDC Product Code

46708-007

Application Number

ANDA078894

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

November 20, 2017

Ingredients

BETADEXInactive

Code: JV039JZZ3AClass: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

PramipexoleActive

Code: 3D867NP06JClass: ACTIBQuantity: 1.5 mg in 1 1

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

POVIDONE K30Inactive

Code: U725QWY32XClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61UClass: IACT

Pramipexole Dihydrochloride

Product Details

NDC Product Code

46708-004

Application Number

ANDA078894

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

November 20, 2017

Ingredients

PramipexoleActive

Code: 3D867NP06JClass: ACTIBQuantity: 0.25 mg in 1 1

BETADEXInactive

Code: JV039JZZ3AClass: IACT

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

POVIDONE K30Inactive

Code: U725QWY32XClass: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61UClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

Pramipexole Dihydrochloride

Product Details

NDC Product Code

46708-005

Application Number

ANDA078894

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

November 20, 2017

Ingredients

PramipexoleActive

Code: 3D867NP06JClass: ACTIBQuantity: 0.5 mg in 1 1

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

BETADEXInactive

Code: JV039JZZ3AClass: IACT

POVIDONE K30Inactive

Code: U725QWY32XClass: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61UClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

Pramipexole Dihydrochloride

Product Details

NDC Product Code

46708-006

Application Number

ANDA078894

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

November 20, 2017

Ingredients

PramipexoleActive

Code: 3D867NP06JClass: ACTIBQuantity: 1 mg in 1 1

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

BETADEXInactive

Code: JV039JZZ3AClass: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

POVIDONE K30Inactive

Code: U725QWY32XClass: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61UClass: IACT

© Copyright 2025. All Rights Reserved by MedPath

Home Terms & Conditions Privacy Policy