pramipexole dihydrochloride

Generic: pramipexole dihydrochloride

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

Drug Facts

Product Profile

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

pramipexole dihydrochloride .25 mg/1

Manufacturer
Alembic Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 46708-612
Product ID 46708-612_43b3cc2f-5e67-4440-a896-69f9be384e33
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078894
Listing Expiration 2026-12-31
Marketing Start 2016-03-22

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 46708612
Hyphenated Format 46708-612

Supplemental Identifiers

RxCUI
859033 859040 859044 859048 859052
UPC
0346708614904 0346708615901 0346708613907 0346708611903
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 ANDA078894 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .25 mg/1
source: ndc
Packaging
  • 90 TABLET in 1 BOTTLE (46708-612-90)
source: ndc

Packages (1)

46708-612-90 90 TABLET in 1 BOTTLE (46708-612-90)

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": "43b3cc2f-5e67-4440-a896-69f9be384e33", "openfda": {"upc": ["0346708614904", "0346708615901", "0346708613907", "0346708611903"], "unii": ["3D867NP06J"], "rxcui": ["859033", "859040", "859044", "859048", "859052"], "spl_set_id": ["0a3ed933-ef5b-4091-8ae9-5768ae18514f"], "manufacturer_name": ["Alembic Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET in 1 BOTTLE (46708-612-90)", "package_ndc": "46708-612-90", "marketing_start_date": "20160322"}], "brand_name": "Pramipexole Dihydrochloride", "product_id": "46708-612_43b3cc2f-5e67-4440-a896-69f9be384e33", "dosage_form": "TABLET", "pharm_class": ["Dopamine Agonists [MoA]", "Nonergot Dopamine Agonist [EPC]"], "product_ndc": "46708-612", "generic_name": "Pramipexole Dihydrochloride", "labeler_name": "Alembic Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Pramipexole Dihydrochloride", "active_ingredients": [{"name": "PRAMIPEXOLE DIHYDROCHLORIDE", "strength": ".25 mg/1"}], "application_number": "ANDA078894", "marketing_category": "ANDA", "marketing_start_date": "20160322", "listing_expiration_date": "20261231"}