pramipexole dihydrochloride extended-release (71034-003)

Drug Facts

Product Profile

Brand Name pramipexole dihydrochloride extended-release

Generic Name pramipexole dihydrochloride

Labeler xiamen lp pharmaceutical co., ltd.

Dosage Form TABLET, EXTENDED RELEASE

Routes

ORAL

Active Ingredients

pramipexole dihydrochloride .75 mg/1

Manufacturer

Xiamen LP Pharmaceutical Co., Ltd.

Identifiers & Regulatory

Product NDC 71034-003

Product ID 71034-003_c4ddb97d-cba5-9f6b-e053-2a95a90a4956

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA212797

Listing Expiration 2026-12-31

Marketing Start 2021-06-11

Pharmacologic Class

Classes

dopamine agonists [moa] nonergot dopamine agonist [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 71034003

Hyphenated Format 71034-003

Supplemental Identifiers

RxCUI

901541 901546

UPC

0371034003306 0371034002309

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 extended-release (source: ndc)

Generic Name pramipexole dihydrochloride (source: ndc)

Application Number ANDA212797 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

.75 mg/1

source: ndc

Packaging

30 TABLET, EXTENDED RELEASE in 1 BOTTLE (71034-003-30)

source: ndc

Packages (1)

71034-003-30 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (71034-003-30)

Ingredients (1)

pramipexole dihydrochloride (.75 mg/1)

Linked Drug Pages (1)

Pramipexole Dihydrochloride Extended-Release ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "c4ddb97d-cba5-9f6b-e053-2a95a90a4956", "openfda": {"upc": ["0371034003306", "0371034002309"], "unii": ["3D867NP06J"], "rxcui": ["901541", "901546"], "spl_set_id": ["1cbd8ddf-4fc1-4cd0-906d-a55a4b8b1c3c"], "manufacturer_name": ["Xiamen LP Pharmaceutical Co., Ltd."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (71034-003-30)", "package_ndc": "71034-003-30", "marketing_start_date": "20210611"}], "brand_name": "Pramipexole Dihydrochloride Extended-Release", "product_id": "71034-003_c4ddb97d-cba5-9f6b-e053-2a95a90a4956", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Dopamine Agonists [MoA]", "Nonergot Dopamine Agonist [EPC]"], "product_ndc": "71034-003", "generic_name": "Pramipexole Dihydrochloride", "labeler_name": "Xiamen LP Pharmaceutical Co., Ltd.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Pramipexole Dihydrochloride", "brand_name_suffix": "Extended-Release", "active_ingredients": [{"name": "PRAMIPEXOLE DIHYDROCHLORIDE", "strength": ".75 mg/1"}], "application_number": "ANDA212797", "marketing_category": "ANDA", "marketing_start_date": "20210611", "listing_expiration_date": "20261231"}