pramipexole dihydrochloride

Generic: pramipexole dihydrochloride

Labeler: sciegen pharmaceuticals inc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name pramipexole dihydrochloride
Generic Name pramipexole dihydrochloride
Labeler sciegen pharmaceuticals inc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

pramipexole dihydrochloride .5 mg/1

Manufacturer
ScieGen Pharmaceuticals Inc

Identifiers & Regulatory

Product NDC 50228-128
Product ID 50228-128_14260a48-c15f-4517-9ce5-d26928b6a5f5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203855
Listing Expiration 2026-12-31
Marketing Start 2014-10-29

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50228128
Hyphenated Format 50228-128

Supplemental Identifiers

RxCUI
858625 859033 859040 859044 859048 859052
UPC
0350228131902 0350228126106 0350228129107 0350228130103
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 ANDA203855 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .5 mg/1
source: ndc
Packaging
  • 1000 TABLET in 1 BOTTLE (50228-128-10)
  • 90 TABLET in 1 BOTTLE (50228-128-90)
source: ndc

Packages (2)

50228-128-10 1000 TABLET in 1 BOTTLE (50228-128-10) 50228-128-90 90 TABLET in 1 BOTTLE (50228-128-90)

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": "14260a48-c15f-4517-9ce5-d26928b6a5f5", "openfda": {"upc": ["0350228131902", "0350228126106", "0350228129107", "0350228130103"], "unii": ["3D867NP06J"], "rxcui": ["858625", "859033", "859040", "859044", "859048", "859052"], "spl_set_id": ["395fee34-43dc-4840-a6b8-70d5736f9c8b"], "manufacturer_name": ["ScieGen Pharmaceuticals Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1000 TABLET in 1 BOTTLE (50228-128-10)", "package_ndc": "50228-128-10", "marketing_start_date": "20141029"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (50228-128-90)", "package_ndc": "50228-128-90", "marketing_start_date": "20141029"}], "brand_name": "Pramipexole Dihydrochloride", "product_id": "50228-128_14260a48-c15f-4517-9ce5-d26928b6a5f5", "dosage_form": "TABLET", "pharm_class": ["Dopamine Agonists [MoA]", "Nonergot Dopamine Agonist [EPC]"], "product_ndc": "50228-128", "generic_name": "Pramipexole Dihydrochloride", "labeler_name": "ScieGen Pharmaceuticals Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Pramipexole Dihydrochloride", "active_ingredients": [{"name": "PRAMIPEXOLE DIHYDROCHLORIDE", "strength": ".5 mg/1"}], "application_number": "ANDA203855", "marketing_category": "ANDA", "marketing_start_date": "20141029", "listing_expiration_date": "20261231"}