pramipexole dihydrochloride

Generic: pramipexole dihydrochloride

Labeler: rising pharma holdings, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name pramipexole dihydrochloride
Generic Name pramipexole dihydrochloride
Labeler rising pharma holdings, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

pramipexole dihydrochloride 1 mg/1

Manufacturer
Rising Pharma Holdings, Inc.

Identifiers & Regulatory

Product NDC 57237-184
Product ID 57237-184_967cfcd5-d04f-4637-a364-632bf7ca72b8
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202633
Listing Expiration 2027-12-31
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 57237184
Hyphenated Format 57237-184

Supplemental Identifiers

RxCUI
858625 859033 859040 859044 859048 859052
UPC
0357237182901 0357237180907 0357237181904
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
  • 1 mg/1
source: ndc
Packaging
  • 90 TABLET in 1 BOTTLE (57237-184-90)
  • 1000 TABLET in 1 BOTTLE (57237-184-99)
source: ndc

Packages (2)

57237-184-90 90 TABLET in 1 BOTTLE (57237-184-90) 57237-184-99 1000 TABLET in 1 BOTTLE (57237-184-99)

Ingredients (1)

pramipexole dihydrochloride (1 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": "967cfcd5-d04f-4637-a364-632bf7ca72b8", "openfda": {"upc": ["0357237182901", "0357237180907", "0357237181904"], "unii": ["3D867NP06J"], "rxcui": ["858625", "859033", "859040", "859044", "859048", "859052"], "spl_set_id": ["56e8d1f6-6dbf-4e11-a177-a56bbfb9f8ec"], "manufacturer_name": ["Rising Pharma Holdings, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET in 1 BOTTLE (57237-184-90)", "package_ndc": "57237-184-90", "marketing_start_date": "20121026"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (57237-184-99)", "package_ndc": "57237-184-99", "marketing_start_date": "20121026"}], "brand_name": "Pramipexole Dihydrochloride", "product_id": "57237-184_967cfcd5-d04f-4637-a364-632bf7ca72b8", "dosage_form": "TABLET", "pharm_class": ["Dopamine Agonists [MoA]", "Nonergot Dopamine Agonist [EPC]"], "product_ndc": "57237-184", "generic_name": "Pramipexole Dihydrochloride", "labeler_name": "Rising Pharma Holdings, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Pramipexole Dihydrochloride", "active_ingredients": [{"name": "PRAMIPEXOLE DIHYDROCHLORIDE", "strength": "1 mg/1"}], "application_number": "ANDA202633", "marketing_category": "ANDA", "marketing_start_date": "20121026", "listing_expiration_date": "20271231"}