pramipexole dihydrochloride extended-release

Generic: pramipexole dihydrochloride

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

Drug Facts

Product Profile

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

pramipexole dihydrochloride .375 mg/1

Manufacturer
Vitruvias Therapeutics, Inc.

Identifiers & Regulatory

Product NDC 69680-145
Product ID 69680-145_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 69680145
Hyphenated Format 69680-145

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 extended-release (source: ndc)
Generic Name pramipexole dihydrochloride (source: ndc)
Application Number ANDA212797 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .375 mg/1
source: ndc
Packaging
  • 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (69680-145-30)
source: ndc

Packages (1)

69680-145-30 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (69680-145-30)

Ingredients (1)

pramipexole dihydrochloride (.375 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 (69680-145-30)", "package_ndc": "69680-145-30", "marketing_start_date": "20210827"}], "brand_name": "Pramipexole Dihydrochloride Extended-Release", "product_id": "69680-145_232ae12c-b9bc-4ca7-982e-d6f43b6c8eec", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Dopamine Agonists [MoA]", "Nonergot Dopamine Agonist [EPC]"], "product_ndc": "69680-145", "generic_name": "Pramipexole Dihydrochloride", "labeler_name": "Vitruvias Therapeutics, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Pramipexole Dihydrochloride", "brand_name_suffix": "Extended-Release", "active_ingredients": [{"name": "PRAMIPEXOLE DIHYDROCHLORIDE", "strength": ".375 mg/1"}], "application_number": "ANDA212797", "marketing_category": "ANDA", "marketing_start_date": "20210827", "listing_expiration_date": "20261231"}