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, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

pramipexole dihydrochloride 4.5 mg/1

Manufacturer
Alembic Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 62332-159
Product ID 62332-159_3e5d0f03-6a98-44eb-8bb5-366364812d50
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 62332159
Hyphenated Format 62332-159

Supplemental Identifiers

RxCUI
901534 901541 901546 901550 901555 1114479 1114485
UPC
0362332155309 0362332158300 0362332156306 0362332160303 0362332157303 0362332159307 0362332154302
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 (62332-159-30)
source: ndc

Packages (1)

62332-159-30 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (62332-159-30)

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": "3e5d0f03-6a98-44eb-8bb5-366364812d50", "openfda": {"upc": ["0362332155309", "0362332158300", "0362332156306", "0362332160303", "0362332157303", "0362332159307", "0362332154302"], "unii": ["3D867NP06J"], "rxcui": ["901534", "901541", "901546", "901550", "901555", "1114479", "1114485"], "spl_set_id": ["e18b67b6-a085-43e5-bb2b-fe74fa00cb65"], "manufacturer_name": ["Alembic Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (62332-159-30)", "package_ndc": "62332-159-30", "marketing_start_date": "20190103"}], "brand_name": "Pramipexole Dihydrochloride", "product_id": "62332-159_3e5d0f03-6a98-44eb-8bb5-366364812d50", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Dopamine Agonists [MoA]", "Nonergot Dopamine Agonist [EPC]"], "product_ndc": "62332-159", "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": "4.5 mg/1"}], "application_number": "ANDA204518", "marketing_category": "ANDA", "marketing_start_date": "20190103", "listing_expiration_date": "20261231"}