pramipexole dihydrochloride

Generic: pramipexole dihydrochloride

Labeler: macleods pharmaceuticals limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name pramipexole dihydrochloride
Generic Name pramipexole dihydrochloride
Labeler macleods pharmaceuticals limited
Dosage Form TABLET
Routes
ORAL
Active Ingredients

pramipexole dihydrochloride .5 mg/1

Manufacturer
Macleods Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 33342-033
Product ID 33342-033_721c81fc-fd21-4d86-ab96-9a329b8e015b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202164
Listing Expiration 2026-12-31
Marketing Start 2012-09-21

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 33342033
Hyphenated Format 33342-033

Supplemental Identifiers

RxCUI
859033 859040 859044 859048 859052
UPC
0333342031105 0333342035103 0333342034106 0333342033109 0333342032102
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 ANDA202164 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .5 mg/1
source: ndc
Packaging
  • 30 BLISTER PACK in 1 CARTON (33342-033-06) / 1 TABLET in 1 BLISTER PACK
  • 90 TABLET in 1 BOTTLE (33342-033-10)
  • 100 BLISTER PACK in 1 CARTON (33342-033-12) / 1 TABLET in 1 BLISTER PACK
  • 500 TABLET in 1 BOTTLE (33342-033-15)
source: ndc

Packages (4)

33342-033-06 30 BLISTER PACK in 1 CARTON (33342-033-06) / 1 TABLET in 1 BLISTER PACK 33342-033-10 90 TABLET in 1 BOTTLE (33342-033-10) 33342-033-12 100 BLISTER PACK in 1 CARTON (33342-033-12) / 1 TABLET in 1 BLISTER PACK 33342-033-15 500 TABLET in 1 BOTTLE (33342-033-15)

Ingredients (1)

pramipexole dihydrochloride (.5 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": "721c81fc-fd21-4d86-ab96-9a329b8e015b", "openfda": {"upc": ["0333342031105", "0333342035103", "0333342034106", "0333342033109", "0333342032102"], "unii": ["3D867NP06J"], "rxcui": ["859033", "859040", "859044", "859048", "859052"], "spl_set_id": ["b8c94917-73a1-44c2-8fd8-07f45054176b"], "manufacturer_name": ["Macleods Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 BLISTER PACK in 1 CARTON (33342-033-06)  / 1 TABLET in 1 BLISTER PACK", "package_ndc": "33342-033-06", "marketing_start_date": "20120921"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (33342-033-10)", "package_ndc": "33342-033-10", "marketing_start_date": "20120921"}, {"sample": false, "description": "100 BLISTER PACK in 1 CARTON (33342-033-12)  / 1 TABLET in 1 BLISTER PACK", "package_ndc": "33342-033-12", "marketing_start_date": "20120921"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (33342-033-15)", "package_ndc": "33342-033-15", "marketing_start_date": "20120921"}], "brand_name": "Pramipexole dihydrochloride", "product_id": "33342-033_721c81fc-fd21-4d86-ab96-9a329b8e015b", "dosage_form": "TABLET", "pharm_class": ["Dopamine Agonists [MoA]", "Nonergot Dopamine Agonist [EPC]"], "product_ndc": "33342-033", "generic_name": "Pramipexole dihydrochloride", "labeler_name": "Macleods Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Pramipexole dihydrochloride", "active_ingredients": [{"name": "PRAMIPEXOLE DIHYDROCHLORIDE", "strength": ".5 mg/1"}], "application_number": "ANDA202164", "marketing_category": "ANDA", "marketing_start_date": "20120921", "listing_expiration_date": "20261231"}