quinidine gluconate

Generic: quinidine gluconate

Labeler: sun pharmaceutical industries, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name quinidine gluconate
Generic Name quinidine gluconate
Labeler sun pharmaceutical industries, inc.
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

quinidine gluconate 324 mg/1

Manufacturer
Sun Pharmaceutical Industries, Inc.

Identifiers & Regulatory

Product NDC 53489-141
Product ID 53489-141_47cec250-341a-4694-a232-93106833a75e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA089338
Listing Expiration 2026-12-31
Marketing Start 1987-02-10

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 53489141
Hyphenated Format 53489-141

Supplemental Identifiers

RxCUI
852920
UPC
0353489141017
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 gluconate (source: ndc)
Application Number ANDA089338 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 324 mg/1
source: ndc
Packaging
  • 100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (53489-141-01)
  • 250 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (53489-141-03)
  • 500 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (53489-141-05)
  • 60 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (53489-141-06)
  • 30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (53489-141-07)
  • 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (53489-141-10)
  • 90 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (53489-141-90)
source: ndc

Packages (7)

53489-141-01 100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (53489-141-01) 53489-141-03 250 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (53489-141-03) 53489-141-05 500 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (53489-141-05) 53489-141-06 60 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (53489-141-06) 53489-141-07 30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (53489-141-07) 53489-141-10 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (53489-141-10) 53489-141-90 90 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (53489-141-90)

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": "47cec250-341a-4694-a232-93106833a75e", "openfda": {"upc": ["0353489141017"], "unii": ["R6875N380F"], "rxcui": ["852920"], "spl_set_id": ["5023f053-fcc4-4c2c-aa59-9ec198ad185e"], "manufacturer_name": ["Sun Pharmaceutical Industries, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (53489-141-01)", "package_ndc": "53489-141-01", "marketing_start_date": "19870210"}, {"sample": false, "description": "250 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (53489-141-03)", "package_ndc": "53489-141-03", "marketing_start_date": "19870210"}, {"sample": false, "description": "500 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (53489-141-05)", "package_ndc": "53489-141-05", "marketing_start_date": "19870210"}, {"sample": false, "description": "60 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (53489-141-06)", "package_ndc": "53489-141-06", "marketing_start_date": "19870210"}, {"sample": false, "description": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (53489-141-07)", "package_ndc": "53489-141-07", "marketing_start_date": "19870210"}, {"sample": false, "description": "1000 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (53489-141-10)", "package_ndc": "53489-141-10", "marketing_start_date": "19870210"}, {"sample": false, "description": "90 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (53489-141-90)", "package_ndc": "53489-141-90", "marketing_start_date": "19870210"}], "brand_name": "Quinidine Gluconate", "product_id": "53489-141_47cec250-341a-4694-a232-93106833a75e", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Antiarrhythmic [EPC]", "Cytochrome P450 2D6 Inhibitor [EPC]", "Cytochrome P450 2D6 Inhibitors [MoA]"], "product_ndc": "53489-141", "generic_name": "Quinidine Gluconate", "labeler_name": "Sun Pharmaceutical Industries, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Quinidine Gluconate", "active_ingredients": [{"name": "QUINIDINE GLUCONATE", "strength": "324 mg/1"}], "application_number": "ANDA089338", "marketing_category": "ANDA", "marketing_start_date": "19870210", "listing_expiration_date": "20261231"}