pramipexole dihydrochloride

Generic: pramipexole dihydrochloride

Labeler: torrent pharmaceuticals limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

pramipexole dihydrochloride .25 mg/1

Manufacturer
Torrent Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 13668-092
Product ID 13668-092_1cd2b9c4-b9dd-4f73-bbe7-6e9f21b7c014
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090865
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 13668092
Hyphenated Format 13668-092

Supplemental Identifiers

RxCUI
858625 859033 859040 859044 859048 859052
UPC
0313668093308 0313668095302 0313668094305 0313668092301 0313668091304 0313668184303
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 ANDA090865 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .25 mg/1
source: ndc
Packaging
  • 500 TABLET in 1 BOTTLE (13668-092-05)
  • 30 TABLET in 1 BOTTLE (13668-092-30)
  • 5500 TABLET in 1 BOTTLE (13668-092-41)
  • 90 TABLET in 1 BOTTLE (13668-092-90)
source: ndc

Packages (4)

13668-092-05 500 TABLET in 1 BOTTLE (13668-092-05) 13668-092-30 30 TABLET in 1 BOTTLE (13668-092-30) 13668-092-41 5500 TABLET in 1 BOTTLE (13668-092-41) 13668-092-90 90 TABLET in 1 BOTTLE (13668-092-90)

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": "1cd2b9c4-b9dd-4f73-bbe7-6e9f21b7c014", "openfda": {"upc": ["0313668093308", "0313668095302", "0313668094305", "0313668092301", "0313668091304", "0313668184303"], "unii": ["3D867NP06J"], "rxcui": ["858625", "859033", "859040", "859044", "859048", "859052"], "spl_set_id": ["60167d7c-469f-455a-a113-561841af5e59"], "manufacturer_name": ["Torrent Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 TABLET in 1 BOTTLE (13668-092-05)", "package_ndc": "13668-092-05", "marketing_start_date": "20101008"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (13668-092-30)", "package_ndc": "13668-092-30", "marketing_start_date": "20101008"}, {"sample": false, "description": "5500 TABLET in 1 BOTTLE (13668-092-41)", "package_ndc": "13668-092-41", "marketing_start_date": "20101008"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (13668-092-90)", "package_ndc": "13668-092-90", "marketing_start_date": "20101008"}], "brand_name": "Pramipexole Dihydrochloride", "product_id": "13668-092_1cd2b9c4-b9dd-4f73-bbe7-6e9f21b7c014", "dosage_form": "TABLET", "pharm_class": ["Dopamine Agonists [MoA]", "Nonergot Dopamine Agonist [EPC]"], "product_ndc": "13668-092", "generic_name": "Pramipexole Dihydrochloride", "labeler_name": "Torrent Pharmaceuticals Limited", "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": "20261231"}