pramipexole dihydrochloride

Generic: pramipexole dihydrochloride

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

Drug Facts

Product Profile

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

pramipexole dihydrochloride .125 mg/1

Manufacturer
Glenmark Pharmaceuticals Inc., USA

Identifiers & Regulatory

Product NDC 68462-330
Product ID 68462-330_75644134-fcad-4dde-8a22-453d18472002
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090781
Listing Expiration 2026-12-31
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 68462330
Hyphenated Format 68462-330

Supplemental Identifiers

RxCUI
858625 859033 859040 859044 859048 859052
UPC
0368462332900 0368462333907 0368462334904 0368462331903 0368462627907 0368462330906
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 ANDA090781 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .125 mg/1
source: ndc
Packaging
  • 500 TABLET in 1 BOTTLE (68462-330-05)
  • 10 BLISTER PACK in 1 CARTON (68462-330-11) / 10 TABLET in 1 BLISTER PACK
  • 63 TABLET in 1 BOTTLE (68462-330-63)
  • 90 TABLET in 1 BOTTLE (68462-330-90)
source: ndc

Packages (4)

68462-330-05 500 TABLET in 1 BOTTLE (68462-330-05) 68462-330-11 10 BLISTER PACK in 1 CARTON (68462-330-11) / 10 TABLET in 1 BLISTER PACK 68462-330-63 63 TABLET in 1 BOTTLE (68462-330-63) 68462-330-90 90 TABLET in 1 BOTTLE (68462-330-90)

Ingredients (1)

pramipexole dihydrochloride (.125 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": "75644134-fcad-4dde-8a22-453d18472002", "openfda": {"upc": ["0368462332900", "0368462333907", "0368462334904", "0368462331903", "0368462627907", "0368462330906"], "unii": ["3D867NP06J"], "rxcui": ["858625", "859033", "859040", "859044", "859048", "859052"], "spl_set_id": ["44c336d2-01d1-4f13-bad9-549cdc3505ec"], "manufacturer_name": ["Glenmark Pharmaceuticals Inc., USA"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 TABLET in 1 BOTTLE (68462-330-05)", "package_ndc": "68462-330-05", "marketing_start_date": "20101008"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (68462-330-11)  / 10 TABLET in 1 BLISTER PACK", "package_ndc": "68462-330-11", "marketing_start_date": "20101008"}, {"sample": false, "description": "63 TABLET in 1 BOTTLE (68462-330-63)", "package_ndc": "68462-330-63", "marketing_start_date": "20101008"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (68462-330-90)", "package_ndc": "68462-330-90", "marketing_start_date": "20101008"}], "brand_name": "Pramipexole dihydrochloride", "product_id": "68462-330_75644134-fcad-4dde-8a22-453d18472002", "dosage_form": "TABLET", "pharm_class": ["Dopamine Agonists [MoA]", "Nonergot Dopamine Agonist [EPC]"], "product_ndc": "68462-330", "generic_name": "Pramipexole dihydrochloride", "labeler_name": "Glenmark Pharmaceuticals Inc., USA", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Pramipexole dihydrochloride", "active_ingredients": [{"name": "PRAMIPEXOLE DIHYDROCHLORIDE", "strength": ".125 mg/1"}], "application_number": "ANDA090781", "marketing_category": "ANDA", "marketing_start_date": "20101008", "listing_expiration_date": "20261231"}