pramipexole dihydrochloride

Generic: pramipexole dihydrochloride

Labeler: american health packaging
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name pramipexole dihydrochloride
Generic Name pramipexole dihydrochloride
Labeler american health packaging
Dosage Form TABLET
Routes
ORAL
Active Ingredients

pramipexole dihydrochloride 1 mg/1

Manufacturer
American Health Packaging

Identifiers & Regulatory

Product NDC 60687-592
Product ID 60687-592_4c252238-7629-b19d-e063-6294a90a4c38
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090865
Listing Expiration 2027-12-31
Marketing Start 2020-08-10

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 60687592
Hyphenated Format 60687-592

Supplemental Identifiers

RxCUI
859040 859044 859052
UNII
3D867NP06J

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
  • 1 mg/1
source: ndc
Packaging
  • 30 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-592-21) / 1 TABLET in 1 BLISTER PACK (60687-592-11)
source: ndc

Packages (1)

60687-592-21 30 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-592-21) / 1 TABLET in 1 BLISTER PACK (60687-592-11)

Ingredients (1)

pramipexole dihydrochloride (1 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": "4c252238-7629-b19d-e063-6294a90a4c38", "openfda": {"unii": ["3D867NP06J"], "rxcui": ["859040", "859044", "859052"], "spl_set_id": ["f4d97c2e-f447-4cfe-b9d4-852323f0cfb5"], "manufacturer_name": ["American Health Packaging"]}, "finished": true, "packaging": [{"sample": false, "description": "30 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-592-21)  / 1 TABLET in 1 BLISTER PACK (60687-592-11)", "package_ndc": "60687-592-21", "marketing_start_date": "20200810"}], "brand_name": "Pramipexole Dihydrochloride", "product_id": "60687-592_4c252238-7629-b19d-e063-6294a90a4c38", "dosage_form": "TABLET", "pharm_class": ["Dopamine Agonists [MoA]", "Nonergot Dopamine Agonist [EPC]"], "product_ndc": "60687-592", "generic_name": "Pramipexole Dihydrochloride", "labeler_name": "American Health Packaging", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Pramipexole Dihydrochloride", "active_ingredients": [{"name": "PRAMIPEXOLE DIHYDROCHLORIDE", "strength": "1 mg/1"}], "application_number": "ANDA090865", "marketing_category": "ANDA", "marketing_start_date": "20200810", "listing_expiration_date": "20271231"}