pramipexole dihydrochloride

Generic: pramipexole dihydrochloride

Labeler: vitruvias therapeutics, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name pramipexole dihydrochloride
Generic Name pramipexole dihydrochloride
Labeler vitruvias therapeutics, inc.
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

pramipexole dihydrochloride .75 mg/1

Manufacturer
Vitruvias Therapeutics, Inc.

Identifiers & Regulatory

Product NDC 69680-146
Product ID 69680-146_232ae12c-b9bc-4ca7-982e-d6f43b6c8eec
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212797
Listing Expiration 2026-12-31
Marketing Start 2021-08-27

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 69680146
Hyphenated Format 69680-146

Supplemental Identifiers

RxCUI
901541 901546
UPC
0369680145303 0369680146300
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 ANDA212797 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .75 mg/1
source: ndc
Packaging
  • 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (69680-146-30)
source: ndc

Packages (1)

69680-146-30 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (69680-146-30)

Ingredients (1)

pramipexole dihydrochloride (.75 mg/1)

Linked Drug Pages (1)

Pramipexole Dihydrochloride Extended-Release, Pramipexole Dihydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "232ae12c-b9bc-4ca7-982e-d6f43b6c8eec", "openfda": {"upc": ["0369680145303", "0369680146300"], "unii": ["3D867NP06J"], "rxcui": ["901541", "901546"], "spl_set_id": ["d07aad1b-e078-4fca-8386-ca2e8e899688"], "manufacturer_name": ["Vitruvias Therapeutics, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (69680-146-30)", "package_ndc": "69680-146-30", "marketing_start_date": "20210827"}], "brand_name": "Pramipexole Dihydrochloride", "product_id": "69680-146_232ae12c-b9bc-4ca7-982e-d6f43b6c8eec", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Dopamine Agonists [MoA]", "Nonergot Dopamine Agonist [EPC]"], "product_ndc": "69680-146", "generic_name": "Pramipexole Dihydrochloride", "labeler_name": "Vitruvias Therapeutics, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Pramipexole Dihydrochloride", "active_ingredients": [{"name": "PRAMIPEXOLE DIHYDROCHLORIDE", "strength": ".75 mg/1"}], "application_number": "ANDA212797", "marketing_category": "ANDA", "marketing_start_date": "20210827", "listing_expiration_date": "20261231"}