FDA.reportPublic FDA data

NDC 0591-5538-01 - Quinidine Gluconate

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
0591-5538
Requested NDC
0591-5538-01
Package NDCs from labels
0591-5538-01, 0591-5538-25, 0591-5538-05
Manufacturer
Watson Laboratories, Inc.
Effective date
2007-02-17
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Quinidine Gluconate Extended-release Tablets USP Revised: June 2005 Rx onlyWatson Laboratories, Inc.2007-02-17HUMAN PRESCRIPTION DRUG LABELING

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0591-5538-01Quinidine Gluconate100 in 1 BOTTLETABLET, EXTENDED RELEASE1001
0591-5538-05Quinidine Gluconate500 in 1 BOTTLETABLET, EXTENDED RELEASE5001
0591-5538-25Quinidine Gluconate250 in 1 BOTTLETABLET, EXTENDED RELEASE2501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0591-5538QUINIDINE GLUCONATE (QUINIDINE GLUCONATE) TABLET, EXTENDED RELEASE [WATSON LABORATORIES, INC.]13 package rows20070223_A08A0F0B-6CF5-4FA4-A861-0B054D6FDDFC.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Quinidine GluconateACTIVE INGREDIENTR6875N380FQUINIDINE GLUCONATE (QUINIDINE GLUCONATE) TABLET, EXTENDED RELEASE [WATSON LABORATORIES, INC.]1
QuinidineACTIVE MOIETYITX08688JLQUINIDINE GLUCONATE (QUINIDINE GLUCONATE) TABLET, EXTENDED RELEASE [WATSON LABORATORIES, INC.]1
Carnauba waxINACTIVE INGREDIENTQUINIDINE GLUCONATE (QUINIDINE GLUCONATE) TABLET, EXTENDED RELEASE [WATSON LABORATORIES, INC.]1
EthylcelluloseINACTIVE INGREDIENTQUINIDINE GLUCONATE (QUINIDINE GLUCONATE) TABLET, EXTENDED RELEASE [WATSON LABORATORIES, INC.]1
Magnesium stearateINACTIVE INGREDIENT70097M6I30QUINIDINE GLUCONATE (QUINIDINE GLUCONATE) TABLET, EXTENDED RELEASE [WATSON LABORATORIES, INC.]1
PovidoneINACTIVE INGREDIENTQUINIDINE GLUCONATE (QUINIDINE GLUCONATE) TABLET, EXTENDED RELEASE [WATSON LABORATORIES, INC.]1

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 ยท 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Quinidine GluconateQUINIDINE GLUCONATEGolden State Medical Supplyad2ad985-cca2-25b5-e053-2995a90a402f2024-08-27Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 852920
Quinidine gluconateQUINIDINE GLUONATEEywa Pharma Inc4db375a3-0cff-4fa7-af7a-2a49e0b922d02021-12-29Warnings, Adverse reactionsExact identifier
rxcui: 852920
Quinidine GluconateQUINIDINE GLUCONATESun Pharmaceutical Industries, Inc.5023f053-fcc4-4c2c-aa59-9ec198ad185e2018-02-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 852920
A08A0F0B-6CF5-4FA4-A861-0B054D6FDDFCA08A0F0B-6CF5-4FA4-A861-0B054D6FDDFC2007-02-17Warnings, Adverse reactionsExact identifier
spl id: A08A0F0B-6CF5-4FA4-A861-0B054D6FDDFC
spl set id: A08A0F0B-6CF5-4FA4-A861-0B054D6FDDFC

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.