pramipexole dihydrochloride

Generic: pramipexole dihydrochloride

Labeler: strides pharma science limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name pramipexole dihydrochloride
Generic Name pramipexole dihydrochloride
Labeler strides pharma science limited
Dosage Form TABLET
Routes
ORAL
Active Ingredients

pramipexole dihydrochloride .125 mg/1

Manufacturer
Strides Pharma Science Limited

Identifiers & Regulatory

Product NDC 64380-746
Product ID 64380-746_94664b38-edd0-4181-8eb2-8bbd9aa3a451
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202702
Listing Expiration 2026-12-31
Marketing Start 2021-02-15

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 64380746
Hyphenated Format 64380-746

Supplemental Identifiers

RxCUI
858625 859033 859040 859044 859048 859052
UPC
0364380746058 0364380747055 0364380748052 0364380750055 0364380749059 0364380751052
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 ANDA202702 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .125 mg/1
source: ndc
Packaging
  • 90 TABLET in 1 BOTTLE (64380-746-05)
source: ndc

Packages (1)

64380-746-05 90 TABLET in 1 BOTTLE (64380-746-05)

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": "94664b38-edd0-4181-8eb2-8bbd9aa3a451", "openfda": {"upc": ["0364380746058", "0364380747055", "0364380748052", "0364380750055", "0364380749059", "0364380751052"], "unii": ["3D867NP06J"], "rxcui": ["858625", "859033", "859040", "859044", "859048", "859052"], "spl_set_id": ["fb2260d6-204c-4d25-a331-0f8340d83a6e"], "manufacturer_name": ["Strides Pharma Science Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET in 1 BOTTLE (64380-746-05)", "package_ndc": "64380-746-05", "marketing_start_date": "20210215"}], "brand_name": "pramipexole dihydrochloride", "product_id": "64380-746_94664b38-edd0-4181-8eb2-8bbd9aa3a451", "dosage_form": "TABLET", "pharm_class": ["Dopamine Agonists [MoA]", "Nonergot Dopamine Agonist [EPC]"], "product_ndc": "64380-746", "generic_name": "pramipexole dihydrochloride", "labeler_name": "Strides Pharma Science Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "pramipexole dihydrochloride", "active_ingredients": [{"name": "PRAMIPEXOLE DIHYDROCHLORIDE", "strength": ".125 mg/1"}], "application_number": "ANDA202702", "marketing_category": "ANDA", "marketing_start_date": "20210215", "listing_expiration_date": "20261231"}