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, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

pramipexole dihydrochloride 4.5 mg/1

Manufacturer
Alembic Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 46708-580
Product ID 46708-580_c9aa6022-4a1b-4fd5-a7ba-04158d9b5a05
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204518
Listing Expiration 2026-12-31
Marketing Start 2019-01-03

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 46708580
Hyphenated Format 46708-580

Supplemental Identifiers

RxCUI
901534 901541 901546 901550 901555 1114479 1114485
UPC
0346708574307 0346708579302 0346708578305 0346708575304 0346708576301
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 ANDA204518 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 4.5 mg/1
source: ndc
Packaging
  • 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (46708-580-30)
source: ndc

Packages (1)

46708-580-30 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (46708-580-30)

Ingredients (1)

pramipexole dihydrochloride (4.5 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": "c9aa6022-4a1b-4fd5-a7ba-04158d9b5a05", "openfda": {"upc": ["0346708574307", "0346708579302", "0346708578305", "0346708575304", "0346708576301"], "unii": ["3D867NP06J"], "rxcui": ["901534", "901541", "901546", "901550", "901555", "1114479", "1114485"], "spl_set_id": ["b6935240-ee81-49ef-adad-fb900d7f5127"], "manufacturer_name": ["Alembic Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (46708-580-30)", "package_ndc": "46708-580-30", "marketing_start_date": "20190103"}], "brand_name": "Pramipexole Dihydrochloride", "product_id": "46708-580_c9aa6022-4a1b-4fd5-a7ba-04158d9b5a05", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Dopamine Agonists [MoA]", "Nonergot Dopamine Agonist [EPC]"], "product_ndc": "46708-580", "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": "4.5 mg/1"}], "application_number": "ANDA204518", "marketing_category": "ANDA", "marketing_start_date": "20190103", "listing_expiration_date": "20261231"}