FDA.reportPublic FDA data

Hydroxychloroquine Sulfate

Product NDC
71335-1523
11-digit product format
713351523
Labeler code
71335
Product ID
71335-1523_11b0ebff-52a1-4f47-bcf7-268f5750d218
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydroxychloroquine Sulfate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA210577
Marketing category
ANDA
Marketing start
2018-05-17
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
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
476a7bfa-95aa-4caa-a32b-b0e157b2cc83Product name120220928
79a2ab33-ef76-b1c3-49e7-8533315e153bProduct name520200716
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71335-1523-12024-05-20C16284748780-11030e364-faea-111a-e063-dadaa90a10e2These 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
71335-1523-22024-05-20C16284748780-11030e364-faea-111a-e063-dadaa90a10e2These 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
71335-1523-32024-05-20C16284748780-11030e364-faea-111a-e063-dadaa90a10e2These 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
71335-1523-42024-05-20C16284748780-11030e364-faea-111a-e063-dadaa90a10e2These 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
71335-1523-52024-05-20C16284748780-11030e364-faea-111a-e063-dadaa90a10e2These 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
71335-1523-62024-05-20C16284748780-11030e364-faea-111a-e063-dadaa90a10e2These 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
71335-1523-72024-05-20C16284748780-11030e364-faea-111a-e063-dadaa90a10e2These 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
71335-1523-82024-05-20C16284748780-11030e364-faea-111a-e063-dadaa90a10e2These 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
71335-1523-92024-05-20C16284748780-11030e364-faea-111a-e063-dadaa90a10e2These 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
71335-1523-12024-01-30C16284748780-11030e364-faea-111a-e063-dadaa90a10e2These 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
71335-1523-22024-01-30C16284748780-11030e364-faea-111a-e063-dadaa90a10e2These 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
71335-1523-32024-01-30C16284748780-11030e364-faea-111a-e063-dadaa90a10e2These 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
71335-1523-42024-01-30C16284748780-11030e364-faea-111a-e063-dadaa90a10e2These 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
71335-1523-52024-01-30C16284748780-11030e364-faea-111a-e063-dadaa90a10e2These 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
71335-1523-62024-01-30C16284748780-11030e364-faea-111a-e063-dadaa90a10e2These 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
71335-1523-72024-01-30C16284748780-11030e364-faea-111a-e063-dadaa90a10e2These 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
71335-1523-82024-01-30C16284748780-11030e364-faea-111a-e063-dadaa90a10e2These 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
71335-1523-92024-01-30C16284748780-11030e364-faea-111a-e063-dadaa90a10e2These 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
71335-1523-1Hydroxychloroquine Sulfate100 in 1 BOTTLETABLET, FILM COATED1008
71335-1523-2Hydroxychloroquine Sulfate30 in 1 BOTTLETABLET, FILM COATED308
71335-1523-3Hydroxychloroquine Sulfate60 in 1 BOTTLETABLET, FILM COATED608
71335-1523-4Hydroxychloroquine Sulfate180 in 1 BOTTLETABLET, FILM COATED1808
71335-1523-5Hydroxychloroquine Sulfate90 in 1 BOTTLETABLET, FILM COATED908
71335-1523-6Hydroxychloroquine Sulfate120 in 1 BOTTLETABLET, FILM COATED1208
71335-1523-7Hydroxychloroquine Sulfate10 in 1 BOTTLETABLET, FILM COATED108
71335-1523-8Hydroxychloroquine Sulfate14 in 1 BOTTLETABLET, FILM COATED148
71335-1523-9Hydroxychloroquine Sulfate20 in 1 BOTTLETABLET, FILM COATED208

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1523HYDROXYCHLOROQUINE SULFATE TABLET, FILM COATED [BRYANT RANCH PREPACK]8Current NDC, Legacy NDC, 9 package rows20240522_da435181-0c5a-4188-8d59-51234116b005.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
979092hydroxychloroquine sulfate 200 MG Oral TabletPSNda435181-0c5a-4188-8d59-51234116b0058
979092hydroxychloroquine sulfate 200 MG Oral TabletSCDda435181-0c5a-4188-8d59-51234116b0058
979092hydroxychloroquine sulfate 200 MG (as hydroxychloroquine 155 MG) Oral TabletSYda435181-0c5a-4188-8d59-51234116b0058

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-1523-171335152301100 TABLET, FILM COATED in 1 BOTTLE (71335-1523-1) 2020-03-260000-00-00NoNoCurrent
71335-1523-27133515230230 TABLET, FILM COATED in 1 BOTTLE (71335-1523-2) 2020-03-130000-00-00NoNoCurrent
71335-1523-37133515230360 TABLET, FILM COATED in 1 BOTTLE (71335-1523-3) 2020-08-030000-00-00NoNoCurrent
71335-1523-471335152304180 TABLET, FILM COATED in 1 BOTTLE (71335-1523-4) 2022-09-210000-00-00NoNoCurrent
71335-1523-57133515230590 TABLET, FILM COATED in 1 BOTTLE (71335-1523-5) 2020-02-260000-00-00NoNoCurrent
71335-1523-671335152306120 TABLET, FILM COATED in 1 BOTTLE (71335-1523-6) 2022-09-210000-00-00NoNoCurrent
71335-1523-77133515230710 TABLET, FILM COATED in 1 BOTTLE (71335-1523-7) 2022-09-210000-00-00NoNoCurrent
71335-1523-87133515230814 TABLET, FILM COATED in 1 BOTTLE (71335-1523-8) 2022-09-210000-00-00NoNoCurrent
71335-1523-97133515230920 TABLET, FILM COATED in 1 BOTTLE (71335-1523-9) 2022-09-210000-00-00NoNoCurrent