FDA.reportPublic FDA data

Quinidine Gluconate

Product NDC
53489-141
11-digit product format
534890141
Labeler code
53489
Product ID
53489-141_47cec250-341a-4694-a232-93106833a75e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Quinidine Gluconate
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA089338
Marketing category
ANDA
Marketing start
1987-02-10
Substance
QUINIDINE GLUCONATE
Active strength
324 mg/1
Pharmacologic classes
Antiarrhythmic [EPC], Cytochrome P450 2D6 Inhibitor [EPC], Cytochrome P450 2D6 Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Quinidine Gluconate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
QUINIDINE GLUCONATE324 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiR6875N380F
Rxcui852920

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
5c89f85a-bde6-5cf8-a351-de14631f6a68Product name220220315
3cea42cf-df28-7a4d-1e04-432ad7cc2928Product name120140508
607c7c15-7bf2-457f-7c66-b7729171afe6Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53489-141-01Quinidine Gluconate100 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE1005
53489-141-03Quinidine Gluconate250 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE2505
53489-141-05Quinidine Gluconate500 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE5005
53489-141-06Quinidine Gluconate60 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE605
53489-141-07Quinidine Gluconate30 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE305
53489-141-10Quinidine Gluconate1000 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE10005
53489-141-90Quinidine Gluconate90 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE905

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
53489-141-01EA - Each53489-141d05c2cbe-a6a4-4b9f-979e-c6ed8e605aee12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Quinidine GluconateACTIVE INGREDIENTR6875N380FQUINIDINE GLUCONATE TABLET, EXTENDED RELEASE [MUTUAL PHARMACEUTICAL COMPANY, INC.]3
QuinidineACTIVE MOIETYITX08688JLQUINIDINE GLUCONATE TABLET, EXTENDED RELEASE [MUTUAL PHARMACEUTICAL COMPANY, INC.]3
Quinidine GluconateACTIVE INGREDIENTR6875N380FQUINIDINE GLUCONATE TABLET, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]2
QuinidineACTIVE MOIETYITX08688JLQUINIDINE GLUCONATE TABLET, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53489-141QUINIDINE GLUCONATE TABLET, EXTENDED RELEASE [SUN PHARMACEUTICAL INDUSTRIES, INC.]5Current NDC, Legacy NDC, 7 package rows20180227_5023f053-fcc4-4c2c-aa59-9ec198ad185e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
852920quiNIDine gluconate 324 MG Extended Release Oral TabletPSN5023f053-fcc4-4c2c-aa59-9ec198ad185e5
852920quinidine gluconate 324 MG Extended Release Oral TabletSCD5023f053-fcc4-4c2c-aa59-9ec198ad185e5
852920quiNIDine gluconate 324 MG Extended Release Oral TabletPSN3af30c3b-944e-4293-baa5-38965b1d11373
852920quinidine gluconate 324 MG Extended Release Oral TabletSCD3af30c3b-944e-4293-baa5-38965b1d11373
852920quiNIDine gluconate 324 MG Extended Release Oral TabletPSNad2ad985-cca2-25b5-e053-2995a90a402f2
852920quinidine gluconate 324 MG Extended Release Oral TabletSCDad2ad985-cca2-25b5-e053-2995a90a402f2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
53489-141-0153489014101100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (53489-141-01) 1987-02-100000-00-00NoNoCurrent
53489-141-0353489014103250 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (53489-141-03) 1987-02-100000-00-00NoNoCurrent
53489-141-0553489014105500 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (53489-141-05) 1987-02-100000-00-00NoNoCurrent
53489-141-065348901410660 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (53489-141-06) 1987-02-100000-00-00NoNoCurrent
53489-141-075348901410730 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (53489-141-07) 1987-02-100000-00-00NoNoCurrent
53489-141-10534890141101000 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (53489-141-10) 1987-02-100000-00-00NoNoCurrent
53489-141-905348901419090 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (53489-141-90) 1987-02-100000-00-00NoNoCurrent