pramipexole dihydrochloride

Generic: pramipexole dihydrochloride

Labeler: major pharmaceuticals
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name pramipexole dihydrochloride
Generic Name pramipexole dihydrochloride
Labeler major pharmaceuticals
Dosage Form TABLET
Routes
ORAL
Active Ingredients

pramipexole dihydrochloride .25 mg/1

Manufacturer
Major Pharmaceuticals

Identifiers & Regulatory

Product NDC 0904-6704
Product ID 0904-6704_9ad8df87-b8f1-4a39-a391-d7f7548de896
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090865
Listing Expiration 2027-12-31
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 09046704
Hyphenated Format 0904-6704

Supplemental Identifiers

RxCUI
859040
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 ANDA090865 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .25 mg/1
source: ndc
Packaging
  • 100 BLISTER PACK in 1 CARTON (0904-6704-61) / 1 TABLET in 1 BLISTER PACK
source: ndc

Packages (1)

0904-6704-61 100 BLISTER PACK in 1 CARTON (0904-6704-61) / 1 TABLET in 1 BLISTER PACK

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": "9ad8df87-b8f1-4a39-a391-d7f7548de896", "openfda": {"unii": ["3D867NP06J"], "rxcui": ["859040"], "spl_set_id": ["978c0e89-35f0-44a2-9302-8bed7e5d60e0"], "manufacturer_name": ["Major Pharmaceuticals"]}, "finished": true, "packaging": [{"sample": false, "description": "100 BLISTER PACK in 1 CARTON (0904-6704-61)  / 1 TABLET in 1 BLISTER PACK", "package_ndc": "0904-6704-61", "marketing_start_date": "20101008"}], "brand_name": "Pramipexole Dihydrochloride", "product_id": "0904-6704_9ad8df87-b8f1-4a39-a391-d7f7548de896", "dosage_form": "TABLET", "pharm_class": ["Dopamine Agonists [MoA]", "Nonergot Dopamine Agonist [EPC]"], "product_ndc": "0904-6704", "generic_name": "Pramipexole Dihydrochloride", "labeler_name": "Major Pharmaceuticals", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Pramipexole Dihydrochloride", "active_ingredients": [{"name": "PRAMIPEXOLE DIHYDROCHLORIDE", "strength": ".25 mg/1"}], "application_number": "ANDA090865", "marketing_category": "ANDA", "marketing_start_date": "20101008", "listing_expiration_date": "20271231"}