Quinidine Sulfate

Product NDC
0185-4346
11-digit product format
001854346
Labeler code
0185
Product ID
0185-4346_e297490d-c30d-48e2-a7b8-25c6429ddaef
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Quinidine Sulfate
Dosage form
TABLET
Route
ORAL
Labeler
Eon Labs, Inc.
Application
ANDA088072
Marketing category
ANDA
Marketing start
1976-11-24
Marketing end
2025-05-31
Substance
QUINIDINE SULFATE
Active strength
200 mg/1
Pharmacologic classes
Antiarrhythmic [EPC], Cytochrome P450 2D6 Inhibitor [EPC], Cytochrome P450 2D6 Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0185-4346-01EA - Each0185-43468d3d4016-71e5-4432-bed8-50ed398a771912012-07-24
0185-4346-10EA - Each0185-4346c6aa665c-b731-494f-a5f1-fb66a2181f0812012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
QUINIDINE SULFATEACTIVE INGREDIENTJ13S2394HEQUINIDINE SULFATE TABLET [EON LABS, INC.]3
QUINIDINEACTIVE MOIETYITX08688JLQUINIDINE SULFATE TABLET [EON LABS, INC.]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UQUINIDINE SULFATE TABLET [EON LABS, INC.]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJQUINIDINE SULFATE TABLET [EON LABS, INC.]3
SUCROSEINACTIVE INGREDIENTC151H8M554QUINIDINE SULFATE TABLET [EON LABS, INC.]3
ZINC STEARATEINACTIVE INGREDIENTH92E6QA4FVQUINIDINE SULFATE TABLET [EON LABS, INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0185-4346QUINIDINE SULFATE TABLET [EON LABS, INC.]8Legacy NDC20220513_a10b6ded-4fe0-4059-bd77-c45acc3c876d.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0185-4346-0100185434601100 TABLET in 1 BOTTLE (0185-4346-01) 100 tablet1976-11-240000-00-00NoNoCurrent