pramipexole dihydrochloride

Generic: pramipexole dihydrochloride

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

Drug Facts

Product Profile

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

pramipexole dihydrochloride .125 mg/1

Manufacturer
Alembic Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 62332-003
Product ID 62332-003_2cfde57a-499e-477a-8e1a-63dca99203f2
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 62332003
Hyphenated Format 62332-003

Supplemental Identifiers

RxCUI
859033 859040 859044 859048 859052
UPC
0362332003907 0362332004904 0362332006908 0362332007905 0362332005901
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
  • .125 mg/1
source: ndc
Packaging
  • 90 TABLET in 1 BOTTLE (62332-003-90)
source: ndc

Packages (1)

62332-003-90 90 TABLET in 1 BOTTLE (62332-003-90)

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": "2cfde57a-499e-477a-8e1a-63dca99203f2", "openfda": {"upc": ["0362332003907", "0362332004904", "0362332006908", "0362332007905", "0362332005901"], "unii": ["3D867NP06J"], "rxcui": ["859033", "859040", "859044", "859048", "859052"], "spl_set_id": ["4fe7106d-4bf6-4794-87cb-8df616994c41"], "manufacturer_name": ["Alembic Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET in 1 BOTTLE (62332-003-90)", "package_ndc": "62332-003-90", "marketing_start_date": "20160322"}], "brand_name": "Pramipexole Dihydrochloride", "product_id": "62332-003_2cfde57a-499e-477a-8e1a-63dca99203f2", "dosage_form": "TABLET", "pharm_class": ["Dopamine Agonists [MoA]", "Nonergot Dopamine Agonist [EPC]"], "product_ndc": "62332-003", "generic_name": "Pramipexole Dihydrochloride", "labeler_name": "Alembic Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Pramipexole Dihydrochloride", "active_ingredients": [{"name": "PRAMIPEXOLE DIHYDROCHLORIDE", "strength": ".125 mg/1"}], "application_number": "ANDA078894", "marketing_category": "ANDA", "marketing_start_date": "20160322", "listing_expiration_date": "20261231"}