pramipexole

Generic: pramipexole

Labeler: camber pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name pramipexole
Generic Name pramipexole
Labeler camber pharmaceuticals, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

pramipexole dihydrochloride .5 mg/1

Manufacturer
Camber Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 31722-908
Product ID 31722-908_540a17f8-b64d-41e1-a96b-d55bc8c48f3d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203855
Listing Expiration 2026-12-31
Marketing Start 2015-08-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 31722908
Hyphenated Format 31722-908

Supplemental Identifiers

RxCUI
858625 859033 859040 859044 859048 859052
UPC
0331722906906
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 (source: ndc)
Generic Name pramipexole (source: ndc)
Application Number ANDA203855 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .5 mg/1
source: ndc
Packaging
  • 500 TABLET in 1 BOTTLE (31722-908-05)
  • 1000 TABLET in 1 BOTTLE (31722-908-10)
  • 90 TABLET in 1 BOTTLE (31722-908-90)
source: ndc

Packages (3)

31722-908-05 500 TABLET in 1 BOTTLE (31722-908-05) 31722-908-10 1000 TABLET in 1 BOTTLE (31722-908-10) 31722-908-90 90 TABLET in 1 BOTTLE (31722-908-90)

Ingredients (1)

pramipexole dihydrochloride (.5 mg/1)

Linked Drug Pages (1)

PRAMIPEXOLE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "540a17f8-b64d-41e1-a96b-d55bc8c48f3d", "openfda": {"upc": ["0331722906906"], "unii": ["3D867NP06J"], "rxcui": ["858625", "859033", "859040", "859044", "859048", "859052"], "spl_set_id": ["a7405a56-de1c-4875-b57f-210c991474ba"], "manufacturer_name": ["Camber Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 TABLET in 1 BOTTLE (31722-908-05)", "package_ndc": "31722-908-05", "marketing_start_date": "20150801"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (31722-908-10)", "package_ndc": "31722-908-10", "marketing_start_date": "20150801"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (31722-908-90)", "package_ndc": "31722-908-90", "marketing_start_date": "20150801"}], "brand_name": "PRAMIPEXOLE", "product_id": "31722-908_540a17f8-b64d-41e1-a96b-d55bc8c48f3d", "dosage_form": "TABLET", "pharm_class": ["Dopamine Agonists [MoA]", "Nonergot Dopamine Agonist [EPC]"], "product_ndc": "31722-908", "generic_name": "PRAMIPEXOLE", "labeler_name": "Camber Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "PRAMIPEXOLE", "active_ingredients": [{"name": "PRAMIPEXOLE DIHYDROCHLORIDE", "strength": ".5 mg/1"}], "application_number": "ANDA203855", "marketing_category": "ANDA", "marketing_start_date": "20150801", "listing_expiration_date": "20261231"}