pramipexole dihydrochloride

Generic: pramipexole dihydrochloride

Labeler: dr. reddy's laboratories limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name pramipexole dihydrochloride
Generic Name pramipexole dihydrochloride
Labeler dr. reddy's laboratories limited
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

pramipexole dihydrochloride .375 mg/1

Manufacturer
Dr. Reddy's Laboratories Limited

Identifiers & Regulatory

Product NDC 55111-611
Product ID 55111-611_4dfe5cc9-1281-c6dc-a6dc-6113fd0aed67
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203354
Listing Expiration 2026-12-31
Marketing Start 2015-08-14

Pharmacologic Class

Classes
dopamine agonists [moa] nonergot dopamine agonist [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 55111611
Hyphenated Format 55111-611

Supplemental Identifiers

RxCUI
901546 901550 901555 901534 901541
UNII
3D867NP06J

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name pramipexole dihydrochloride (source: ndc)
Generic Name pramipexole dihydrochloride (source: ndc)
Application Number ANDA203354 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .375 mg/1
source: ndc
Packaging
  • 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (55111-611-30)
source: ndc

Packages (1)

55111-611-30 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (55111-611-30)

Ingredients (1)

pramipexole dihydrochloride (.375 mg/1)

Linked Drug Pages (1)

Pramipexole dihydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "4dfe5cc9-1281-c6dc-a6dc-6113fd0aed67", "openfda": {"unii": ["3D867NP06J"], "rxcui": ["901546", "901550", "901555", "901534", "901541"], "spl_set_id": ["00699692-532a-68fd-8a51-3770a81b2208"], "manufacturer_name": ["Dr. Reddy's Laboratories Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (55111-611-30)", "package_ndc": "55111-611-30", "marketing_start_date": "20150814"}], "brand_name": "Pramipexole dihydrochloride", "product_id": "55111-611_4dfe5cc9-1281-c6dc-a6dc-6113fd0aed67", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Dopamine Agonists [MoA]", "Nonergot Dopamine Agonist [EPC]"], "product_ndc": "55111-611", "generic_name": "Pramipexole dihydrochloride", "labeler_name": "Dr. Reddy's Laboratories Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Pramipexole dihydrochloride", "active_ingredients": [{"name": "PRAMIPEXOLE DIHYDROCHLORIDE", "strength": ".375 mg/1"}], "application_number": "ANDA203354", "marketing_category": "ANDA", "marketing_start_date": "20150814", "listing_expiration_date": "20261231"}