pramipexole dihydrochloride

Generic: pramipexole dihydrochloride

Labeler: aurobindo pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name pramipexole dihydrochloride
Generic Name pramipexole dihydrochloride
Labeler aurobindo pharma limited
Dosage Form TABLET
Routes
ORAL
Active Ingredients

pramipexole dihydrochloride .125 mg/1

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 65862-604
Product ID 65862-604_1e01cf5f-29b7-40ce-8c46-40f8dc65ce3e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202633
Listing Expiration 2026-12-31
Marketing Start 2012-10-26

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 65862604
Hyphenated Format 65862-604

Supplemental Identifiers

RxCUI
858625 859033 859040 859044 859048 859052
UPC
0365862604903
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 ANDA202633 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .125 mg/1
source: ndc
Packaging
  • 10 BLISTER PACK in 1 CARTON (65862-604-78) / 10 TABLET in 1 BLISTER PACK (65862-604-10)
  • 90 TABLET in 1 BOTTLE (65862-604-90)
  • 1000 TABLET in 1 BOTTLE (65862-604-99)
source: ndc

Packages (3)

65862-604-78 10 BLISTER PACK in 1 CARTON (65862-604-78) / 10 TABLET in 1 BLISTER PACK (65862-604-10) 65862-604-90 90 TABLET in 1 BOTTLE (65862-604-90) 65862-604-99 1000 TABLET in 1 BOTTLE (65862-604-99)

Ingredients (1)

pramipexole dihydrochloride (.125 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": "1e01cf5f-29b7-40ce-8c46-40f8dc65ce3e", "openfda": {"upc": ["0365862604903"], "unii": ["3D867NP06J"], "rxcui": ["858625", "859033", "859040", "859044", "859048", "859052"], "spl_set_id": ["3f90971a-e005-4dd3-bb93-b09125ada3c8"], "manufacturer_name": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 BLISTER PACK in 1 CARTON (65862-604-78)  / 10 TABLET in 1 BLISTER PACK (65862-604-10)", "package_ndc": "65862-604-78", "marketing_start_date": "20121026"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (65862-604-90)", "package_ndc": "65862-604-90", "marketing_start_date": "20121026"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (65862-604-99)", "package_ndc": "65862-604-99", "marketing_start_date": "20121026"}], "brand_name": "Pramipexole Dihydrochloride", "product_id": "65862-604_1e01cf5f-29b7-40ce-8c46-40f8dc65ce3e", "dosage_form": "TABLET", "pharm_class": ["Dopamine Agonists [MoA]", "Nonergot Dopamine Agonist [EPC]"], "product_ndc": "65862-604", "generic_name": "Pramipexole Dihydrochloride", "labeler_name": "Aurobindo Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Pramipexole Dihydrochloride", "active_ingredients": [{"name": "PRAMIPEXOLE DIHYDROCHLORIDE", "strength": ".125 mg/1"}], "application_number": "ANDA202633", "marketing_category": "ANDA", "marketing_start_date": "20121026", "listing_expiration_date": "20261231"}