Quinidine gluconate

Product NDC
71930-016
11-digit product format
719300016
Labeler code
71930
Product ID
71930-016_d4e8ed08-f426-4fdb-9dd3-d46730e9f81b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Quinidine gluonate
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Eywa Pharma Inc
Application
ANDA212589
Marketing category
ANDA
Marketing start
2022-03-20
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
71930-016-12Quinidine gluconate100 in 1 BOTTLETABLET, EXTENDED RELEASE1002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71930-016-12EA - Each71930-016eb88db17-5586-46d8-bb1e-7c796c7c9bae12022-08-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71930-016QUINIDINE GLUCONATE (QUINIDINE GLUONATE) TABLET, EXTENDED RELEASE [EYWA PHARMA INC]2Current NDC, Legacy NDC, 1 package rows20220320_4db375a3-0cff-4fa7-af7a-2a49e0b922d0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
852920quiNIDine gluconate 324 MG Extended Release Oral TabletPSN4db375a3-0cff-4fa7-af7a-2a49e0b922d02
852920quinidine gluconate 324 MG Extended Release Oral TabletSCD4db375a3-0cff-4fa7-af7a-2a49e0b922d02

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71930-016-1271930001612100 TABLET, EXTENDED RELEASE in 1 BOTTLE (71930-016-12) 2022-03-200000-00-00NoNoCurrent