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, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

pramipexole dihydrochloride 4.5 mg/1

Manufacturer
Macleods Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 33342-214
Product ID 33342-214_4bae794e-6b1f-4630-9d00-a4524fffa0b9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206156
Listing Expiration 2026-12-31
Marketing Start 2020-08-24

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 33342214
Hyphenated Format 33342-214

Supplemental Identifiers

RxCUI
901534 901541 901546 901550 901555 1114479 1114485
UPC
0333342209078 0333342214072 0333342212122 0333342210074 0333342208071 0333342211071 0333342213075
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 ANDA206156 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 4.5 mg/1
source: ndc
Packaging
  • 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (33342-214-07)
  • 10 BLISTER PACK in 1 CARTON (33342-214-12) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
source: ndc

Packages (2)

33342-214-07 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (33342-214-07) 33342-214-12 10 BLISTER PACK in 1 CARTON (33342-214-12) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK

Ingredients (1)

pramipexole dihydrochloride (4.5 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": "4bae794e-6b1f-4630-9d00-a4524fffa0b9", "openfda": {"upc": ["0333342209078", "0333342214072", "0333342212122", "0333342210074", "0333342208071", "0333342211071", "0333342213075"], "unii": ["3D867NP06J"], "rxcui": ["901534", "901541", "901546", "901550", "901555", "1114479", "1114485"], "spl_set_id": ["1dbb8d2f-e0d9-4f8b-89d2-2a03496ef7be"], "manufacturer_name": ["Macleods Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (33342-214-07)", "package_ndc": "33342-214-07", "marketing_start_date": "20200824"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (33342-214-12)  / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK", "package_ndc": "33342-214-12", "marketing_start_date": "20200824"}], "brand_name": "Pramipexole Dihydrochloride", "product_id": "33342-214_4bae794e-6b1f-4630-9d00-a4524fffa0b9", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Dopamine Agonists [MoA]", "Nonergot Dopamine Agonist [EPC]"], "product_ndc": "33342-214", "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": "4.5 mg/1"}], "application_number": "ANDA206156", "marketing_category": "ANDA", "marketing_start_date": "20200824", "listing_expiration_date": "20261231"}