pramipexole dihydrochloride

Generic: pramipexole dihydrochloride

Labeler: bryant ranch prepack
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name pramipexole dihydrochloride
Generic Name pramipexole dihydrochloride
Labeler bryant ranch prepack
Dosage Form TABLET
Routes
ORAL
Active Ingredients

pramipexole dihydrochloride .25 mg/1

Manufacturer
Bryant Ranch Prepack

Identifiers & Regulatory

Product NDC 63629-5013
Product ID 63629-5013_528864d0-bf5e-469e-98d9-6d53e1eeae6e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090865
Listing Expiration 2026-12-31
Marketing Start 2010-10-08

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 636295013
Hyphenated Format 63629-5013

Supplemental Identifiers

RxCUI
859040
UNII
3D867NP06J

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 ANDA090865 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .25 mg/1
source: ndc
Packaging
  • 90 TABLET in 1 BOTTLE (63629-5013-1)
  • 30 TABLET in 1 BOTTLE (63629-5013-2)
  • 60 TABLET in 1 BOTTLE (63629-5013-3)
source: ndc

Packages (3)

63629-5013-1 90 TABLET in 1 BOTTLE (63629-5013-1) 63629-5013-2 30 TABLET in 1 BOTTLE (63629-5013-2) 63629-5013-3 60 TABLET in 1 BOTTLE (63629-5013-3)

Ingredients (1)

pramipexole dihydrochloride (.25 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": "528864d0-bf5e-469e-98d9-6d53e1eeae6e", "openfda": {"unii": ["3D867NP06J"], "rxcui": ["859040"], "spl_set_id": ["dd4b4e2a-97b5-417d-bb90-bec692dc359b"], "manufacturer_name": ["Bryant Ranch Prepack"]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET in 1 BOTTLE (63629-5013-1)", "package_ndc": "63629-5013-1", "marketing_start_date": "20130522"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (63629-5013-2)", "package_ndc": "63629-5013-2", "marketing_start_date": "20130716"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (63629-5013-3)", "package_ndc": "63629-5013-3", "marketing_start_date": "20240905"}], "brand_name": "Pramipexole Dihydrochloride", "product_id": "63629-5013_528864d0-bf5e-469e-98d9-6d53e1eeae6e", "dosage_form": "TABLET", "pharm_class": ["Dopamine Agonists [MoA]", "Nonergot Dopamine Agonist [EPC]"], "product_ndc": "63629-5013", "generic_name": "Pramipexole Dihydrochloride", "labeler_name": "Bryant Ranch Prepack", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Pramipexole Dihydrochloride", "active_ingredients": [{"name": "PRAMIPEXOLE DIHYDROCHLORIDE", "strength": ".25 mg/1"}], "application_number": "ANDA090865", "marketing_category": "ANDA", "marketing_start_date": "20101008", "listing_expiration_date": "20261231"}