pramipexole dihydrochloride

Generic: pramipexole dihydrochloride

Labeler: unichem pharmaceuticals (usa), inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name pramipexole dihydrochloride
Generic Name pramipexole dihydrochloride
Labeler unichem pharmaceuticals (usa), inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

pramipexole dihydrochloride .5 mg/1

Manufacturer
Unichem Pharmaceuticals (USA), Inc.

Identifiers & Regulatory

Product NDC 29300-209
Product ID 29300-209_2ab8bb44-e4ba-4ae0-8ce9-0e9153de59f3
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207011
Listing Expiration 2026-12-31
Marketing Start 2019-03-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 29300209
Hyphenated Format 29300-209

Supplemental Identifiers

RxCUI
858625 859033 859040 859044 859048 859052
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 ANDA207011 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .5 mg/1
source: ndc
Packaging
  • 1000 TABLET in 1 BOTTLE, PLASTIC (29300-209-10)
  • 90 TABLET in 1 BOTTLE, PLASTIC (29300-209-19)
source: ndc

Packages (2)

29300-209-10 1000 TABLET in 1 BOTTLE, PLASTIC (29300-209-10) 29300-209-19 90 TABLET in 1 BOTTLE, PLASTIC (29300-209-19)

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": "2ab8bb44-e4ba-4ae0-8ce9-0e9153de59f3", "openfda": {"unii": ["3D867NP06J"], "rxcui": ["858625", "859033", "859040", "859044", "859048", "859052"], "spl_set_id": ["b978aa75-c62d-444b-9ec6-6c0d21a66688"], "manufacturer_name": ["Unichem Pharmaceuticals (USA), Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1000 TABLET in 1 BOTTLE, PLASTIC (29300-209-10)", "package_ndc": "29300-209-10", "marketing_start_date": "20190301"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE, PLASTIC (29300-209-19)", "package_ndc": "29300-209-19", "marketing_start_date": "20190301"}], "brand_name": "pramipexole dihydrochloride", "product_id": "29300-209_2ab8bb44-e4ba-4ae0-8ce9-0e9153de59f3", "dosage_form": "TABLET", "pharm_class": ["Dopamine Agonists [MoA]", "Nonergot Dopamine Agonist [EPC]"], "product_ndc": "29300-209", "generic_name": "pramipexole dihydrochloride", "labeler_name": "Unichem Pharmaceuticals (USA), Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "pramipexole dihydrochloride", "active_ingredients": [{"name": "PRAMIPEXOLE DIHYDROCHLORIDE", "strength": ".5 mg/1"}], "application_number": "ANDA207011", "marketing_category": "ANDA", "marketing_start_date": "20190301", "listing_expiration_date": "20261231"}