FDA.reportPublic FDA data

QUINIDINE SULFATE

Product NDC
42806-513
11-digit product format
428060513
Labeler code
42806
Product ID
42806-513_80df716e-b0d6-4b0f-b0f4-879874d7ed05
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
quinidine sulfate tablet
Dosage form
TABLET
Route
ORAL
Labeler
EPIC PHARMA, LLC
Application
ANDA088072
Marketing category
ANDA
Marketing start
2021-12-15
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
QUINIDINE SULFATE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
QUINIDINE SULFATE200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiJ13S2394HE
Rxcui852877, 852913

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
42806-513-01QUINIDINE SULFATE100 in 1 BOTTLETABLET1002
42806-513-30QUINIDINE SULFATE30 in 1 BOTTLETABLET302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42806-513-30EA - Each42806-513ee024f78-c4b0-4b00-87ba-43a31880e43a12022-01-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42806-513QUINIDINE SULFATE (QUINIDINE SULFATE TABLET) TABLET [EPIC PHARMA, LLC]2Current NDC, Legacy NDC, 2 package rows20231221_b0d6341b-d880-4f0b-8844-bc788c03004a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
852877quiNIDine sulfate 200 MG Oral TabletPSNb0d6341b-d880-4f0b-8844-bc788c03004a2
852913quiNIDine sulfate 300 MG Oral TabletPSNb0d6341b-d880-4f0b-8844-bc788c03004a2
852877quinidine sulfate 200 MG Oral TabletSCDb0d6341b-d880-4f0b-8844-bc788c03004a2
852913quinidine sulfate 300 MG Oral TabletSCDb0d6341b-d880-4f0b-8844-bc788c03004a2
852877quinidine sulfate 200 MG (quinidine 166 MG) Oral TabletSYb0d6341b-d880-4f0b-8844-bc788c03004a2
852913quinidine sulfate 300 MG (quinidine 249 MG) Oral TabletSYb0d6341b-d880-4f0b-8844-bc788c03004a2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42806-513-0142806051301100 TABLET in 1 BOTTLE (42806-513-01) 100 tablet2021-12-150000-00-00NoNoCurrent
42806-513-304280605133030 TABLET in 1 BOTTLE (42806-513-30) 30 tablet2022-01-020000-00-00NoNoCurrent