pramipexole dihydrochloride

Generic: pramipexole dihydrochloride

Labeler: ncs healthcare of ky, llc dba vangard labs
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name pramipexole dihydrochloride
Generic Name pramipexole dihydrochloride
Labeler ncs healthcare of ky, llc dba vangard labs
Dosage Form TABLET
Routes
ORAL
Active Ingredients

pramipexole dihydrochloride .25 mg/1

Manufacturer
NCS HealthCare of KY, LLC dba Vangard Labs

Identifiers & Regulatory

Product NDC 0615-8551
Product ID 0615-8551_7d36ceb3-2235-42bc-bb8c-e7863c24b1cb
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090781
Listing Expiration 2026-12-31
Marketing Start 2010-10-08

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 06158551
Hyphenated Format 0615-8551

Supplemental Identifiers

RxCUI
859040 859044
UNII
3D867NP06J

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 ANDA090781 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .25 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BLISTER PACK (0615-8551-39)
source: ndc

Packages (1)

0615-8551-39 30 TABLET in 1 BLISTER PACK (0615-8551-39)

Ingredients (1)

pramipexole dihydrochloride (.25 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": "7d36ceb3-2235-42bc-bb8c-e7863c24b1cb", "openfda": {"unii": ["3D867NP06J"], "rxcui": ["859040", "859044"], "spl_set_id": ["5e6f2187-a5cc-481e-b0a1-d38d3f92e822"], "manufacturer_name": ["NCS HealthCare of KY, LLC dba Vangard Labs"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BLISTER PACK (0615-8551-39)", "package_ndc": "0615-8551-39", "marketing_start_date": "20241007"}], "brand_name": "Pramipexole dihydrochloride", "product_id": "0615-8551_7d36ceb3-2235-42bc-bb8c-e7863c24b1cb", "dosage_form": "TABLET", "pharm_class": ["Dopamine Agonists [MoA]", "Nonergot Dopamine Agonist [EPC]"], "product_ndc": "0615-8551", "generic_name": "Pramipexole dihydrochloride", "labeler_name": "NCS HealthCare of KY, LLC dba Vangard Labs", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Pramipexole dihydrochloride", "active_ingredients": [{"name": "PRAMIPEXOLE DIHYDROCHLORIDE", "strength": ".25 mg/1"}], "application_number": "ANDA090781", "marketing_category": "ANDA", "marketing_start_date": "20101008", "listing_expiration_date": "20261231"}