FDA.reportPublic FDA data

Hydroxychloroquine sulfate

Product NDC
50090-5573
11-digit product format
500905573
Labeler code
50090
Product ID
50090-5573_909ab143-2d20-49be-b4e8-2f4c82bade24
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydroxychloroquine sulfate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA040657
Marketing category
ANDA
Marketing start
2019-10-01
Substance
HYDROXYCHLOROQUINE SULFATE
Active strength
200 mg/1
Pharmacologic classes
Antimalarial [EPC], Antirheumatic Agent [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Hydroxychloroquine sulfate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HYDROXYCHLOROQUINE SULFATE200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii8Q2869CNVH
Rxcui979092

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
50090-5573-12023-02-07C16284748780-1f386c64a-1408-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use HYDROXYCHLOROQUINE SULFATE TABLETS safely and effectively. See full prescribing information for HYDROXYCHLOROQUINE SULFATE TABLETS. HYDROXYCHLOROQUINE SULFATE Tablets, for oral use Initial U.S. Approval: 1955
50090-5573-22023-02-07C16284748780-1f386c64a-1408-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use HYDROXYCHLOROQUINE SULFATE TABLETS safely and effectively. See full prescribing information for HYDROXYCHLOROQUINE SULFATE TABLETS. HYDROXYCHLOROQUINE SULFATE Tablets, for oral use Initial U.S. Approval: 1955
50090-5573-12023-01-30C16284748780-1f386c64a-1408-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use HYDROXYCHLOROQUINE SULFATE TABLETS safely and effectively. See full prescribing information for HYDROXYCHLOROQUINE SULFATE TABLETS. HYDROXYCHLOROQUINE SULFATE Tablets, for oral use Initial U.S. Approval: 1955
50090-5573-22023-01-30C16284748780-1f386c64a-1408-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use HYDROXYCHLOROQUINE SULFATE TABLETS safely and effectively. See full prescribing information for HYDROXYCHLOROQUINE SULFATE TABLETS. HYDROXYCHLOROQUINE SULFATE Tablets, for oral use Initial U.S. Approval: 1955

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-5573-0Hydroxychloroquine sulfate30 in 1 BOTTLETABLET, FILM COATED308
50090-5573-1Hydroxychloroquine sulfate60 in 1 BOTTLETABLET, FILM COATED608
50090-5573-2Hydroxychloroquine sulfate90 in 1 BOTTLETABLET, FILM COATED908

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5573HYDROXYCHLOROQUINE SULFATE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]8Current NDC, Legacy NDC, 3 package rows20250510_6a06ad3d-2d6c-4e51-93f5-8f782b86975b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
979092hydroxychloroquine sulfate 200 MG Oral TabletPSN6a06ad3d-2d6c-4e51-93f5-8f782b86975b8
979092hydroxychloroquine sulfate 200 MG Oral TabletSCD6a06ad3d-2d6c-4e51-93f5-8f782b86975b8
979092hydroxychloroquine sulfate 200 MG (as hydroxychloroquine 155 MG) Oral TabletSY6a06ad3d-2d6c-4e51-93f5-8f782b86975b8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-5573-05009055730030 in 1 BOTTLEHistorical
50090-5573-15009055730160 TABLET, FILM COATED in 1 BOTTLE (50090-5573-1) 2021-06-290000-00-00NoNoCurrent
50090-5573-25009055730290 TABLET, FILM COATED in 1 BOTTLE (50090-5573-2) 2021-06-290000-00-00NoNoCurrent