Quinidine Sulfate

Product NDC
0185-1047
11-digit product format
001851047
Labeler code
0185
Product ID
0185-1047_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
1983-09-26
Marketing end
2025-05-31
Substance
QUINIDINE SULFATE
Active strength
300 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
0185-1047-01EA - Each0185-10474f88a295-47e1-46b0-aece-0302b79f621312012-07-24
0185-1047-10EA - Each0185-1047e3a4e9d9-1837-46b0-bc72-aabf548039e412012-07-24

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
0185-1047QUINIDINE 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
0185-1047-0100185104701100 TABLET in 1 BOTTLE (0185-1047-01) 100 tablet1983-09-260000-00-00NoNoCurrent