quinidine gluconate

Generic: quinidine gluonate

Labeler: eywa pharma inc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name quinidine gluconate
Generic Name quinidine gluonate
Labeler eywa pharma inc
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

quinidine gluconate 324 mg/1

Manufacturer
Eywa Pharma Inc

Identifiers & Regulatory

Product NDC 71930-016
Product ID 71930-016_d4e8ed08-f426-4fdb-9dd3-d46730e9f81b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212589
Listing Expiration 2026-12-31
Marketing Start 2022-03-20

Pharmacologic Class

Classes
antiarrhythmic [epc] cytochrome p450 2d6 inhibitor [epc] cytochrome p450 2d6 inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 71930016
Hyphenated Format 71930-016

Supplemental Identifiers

RxCUI
852920
UPC
0371930016127
UNII
R6875N380F

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 quinidine gluconate (source: ndc)
Generic Name quinidine gluonate (source: ndc)
Application Number ANDA212589 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 324 mg/1
source: ndc
Packaging
  • 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (71930-016-12)
source: ndc

Packages (1)

71930-016-12 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (71930-016-12)

Ingredients (1)

quinidine gluconate (324 mg/1)

Linked Drug Pages (1)

Quinidine gluconate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "d4e8ed08-f426-4fdb-9dd3-d46730e9f81b", "openfda": {"upc": ["0371930016127"], "unii": ["R6875N380F"], "rxcui": ["852920"], "spl_set_id": ["4db375a3-0cff-4fa7-af7a-2a49e0b922d0"], "manufacturer_name": ["Eywa Pharma Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE (71930-016-12)", "package_ndc": "71930-016-12", "marketing_start_date": "20220320"}], "brand_name": "Quinidine gluconate", "product_id": "71930-016_d4e8ed08-f426-4fdb-9dd3-d46730e9f81b", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Antiarrhythmic [EPC]", "Cytochrome P450 2D6 Inhibitor [EPC]", "Cytochrome P450 2D6 Inhibitors [MoA]"], "product_ndc": "71930-016", "generic_name": "Quinidine gluonate", "labeler_name": "Eywa Pharma Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Quinidine gluconate", "active_ingredients": [{"name": "QUINIDINE GLUCONATE", "strength": "324 mg/1"}], "application_number": "ANDA212589", "marketing_category": "ANDA", "marketing_start_date": "20220320", "listing_expiration_date": "20261231"}