pramipexole dihydrochloride

Generic: pramipexole dihydrochloride

Labeler: northstar rxllc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name pramipexole dihydrochloride
Generic Name pramipexole dihydrochloride
Labeler northstar rxllc
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

pramipexole dihydrochloride 4.5 mg/1

Manufacturer
NorthStar RxLLC

Identifiers & Regulatory

Product NDC 16714-922
Product ID 16714-922_b78c4a9c-3ad8-443e-ada5-853385411cfc
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206156
Listing Expiration 2026-12-31
Marketing Start 2019-03-06

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 16714922
Hyphenated Format 16714-922

Supplemental Identifiers

RxCUI
901534 901541 901546 901550 901555 1114479
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 (16714-922-01)
source: ndc

Packages (1)

16714-922-01 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (16714-922-01)

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": "b78c4a9c-3ad8-443e-ada5-853385411cfc", "openfda": {"unii": ["3D867NP06J"], "rxcui": ["901534", "901541", "901546", "901550", "901555", "1114479"], "spl_set_id": ["946c8a72-8c48-4925-93d3-7940f4c0fd29"], "manufacturer_name": ["NorthStar RxLLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (16714-922-01)", "package_ndc": "16714-922-01", "marketing_start_date": "20190306"}], "brand_name": "Pramipexole Dihydrochloride", "product_id": "16714-922_b78c4a9c-3ad8-443e-ada5-853385411cfc", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Dopamine Agonists [MoA]", "Nonergot Dopamine Agonist [EPC]"], "product_ndc": "16714-922", "generic_name": "Pramipexole Dihydrochloride", "labeler_name": "NorthStar RxLLC", "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": "20190306", "listing_expiration_date": "20261231"}