HYDROXYCHLOROQUINE SULFATE

Product NDC
50090-5388
11-digit product format
500905388
Labeler code
50090
Product ID
50090-5388_e26c2f75-19db-4144-a6a1-02d18efdfee1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
HYDROXYCHLOROQUINE SULFATE
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA201691
Marketing category
ANDA
Marketing start
2018-06-18
Marketing end
0000-00-00
Substance
HYDROXYCHLOROQUINE SULFATE
Active strength
200 mg/1
Pharmacologic classes
Antirheumatic Agent [EPC],Antimalarial [EPC]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
476a7bfa-95aa-4caa-a32b-b0e157b2cc83Product name120220928
79a2ab33-ef76-b1c3-49e7-8533315e153bProduct name520200716

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-5388-12023-01-30C16284748780-1f386c649-c30f-0266-e053-dadaa90a7c1afe39f2c0-1b3d-486b-ad59-f88b28404d32
50090-5388-22023-01-30C16284748780-1f386c649-c30f-0266-e053-dadaa90a7c1afe39f2c0-1b3d-486b-ad59-f88b28404d32

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-5388-1HYDROXYCHLOROQUINE SULFATE60 in 1 BOTTLETABLET603
50090-5388-2HYDROXYCHLOROQUINE SULFATE90 in 1 BOTTLETABLET903

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5388HYDROXYCHLOROQUINE SULFATE TABLET [A-S MEDICATION SOLUTIONS]3Legacy NDC, 2 package rows20210303_fe39f2c0-1b3d-486b-ad59-f88b28404d32.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
979092hydroxychloroquine sulfate 200 MG Oral TabletPSNfe39f2c0-1b3d-486b-ad59-f88b28404d323
979092hydroxychloroquine sulfate 200 MG Oral TabletSCDfe39f2c0-1b3d-486b-ad59-f88b28404d323
979092hydroxychloroquine sulfate 200 MG (as hydroxychloroquine 155 MG) Oral TabletSYfe39f2c0-1b3d-486b-ad59-f88b28404d323

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-5388-15009053880160 TABLET in 1 BOTTLE (50090-5388-1) 60 tablet2020-11-230000-00-00NoNoCurrent
50090-5388-25009053880290 TABLET in 1 BOTTLE (50090-5388-2) 90 tablet2020-11-230000-00-00NoNoCurrent