FDA.reportPublic FDA data

Hydroxychloroquine Sulfate

Product NDC
50090-4659
11-digit product format
500904659
Labeler code
50090
Product ID
50090-4659_755581f8-6167-46af-991f-9cb92a16d06c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydroxychloroquine Sulfate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Hydroxychloroquine Sulfate
Listing expiration
2027-12-31

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
50090-4659-12024-01-08C16284748780-1f386c64a-309c-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
50090-4659-22024-01-08C16284748780-1f386c64a-309c-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
50090-4659-32024-01-08C16284748780-1f386c64a-309c-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
50090-4659-12023-01-30C16284748780-1f386c64a-309c-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
50090-4659-22023-01-30C16284748780-1f386c64a-309c-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
50090-4659-32023-01-30C16284748780-1f386c64a-309c-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
50090-4659-1Hydroxychloroquine Sulfate60 in 1 BOTTLETABLET, FILM COATED6012
50090-4659-2Hydroxychloroquine Sulfate90 in 1 BOTTLETABLET, FILM COATED9012
50090-4659-3Hydroxychloroquine Sulfate12 in 1 BOTTLETABLET, FILM COATED1212

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-4659-1EA - Each50090-465909bbf6cf-74ff-4b72-a93b-bd4583c0d4a412022-12-07
50090-4659-2EA - Each50090-46597a46102e-9d51-4551-8fc9-bc587de09cc212022-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4659HYDROXYCHLOROQUINE SULFATE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]10Current NDC, Legacy NDC, 3 package rows20250430_87076a61-ce76-475b-ac6d-c33ba617195d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
979092hydroxychloroquine sulfate 200 MG Oral TabletPSN87076a61-ce76-475b-ac6d-c33ba617195d12
979092hydroxychloroquine sulfate 200 MG Oral TabletSCD87076a61-ce76-475b-ac6d-c33ba617195d12
979092hydroxychloroquine sulfate 200 MG (as hydroxychloroquine 155 MG) Oral TabletSY87076a61-ce76-475b-ac6d-c33ba617195d12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-4659-15009046590160 TABLET, FILM COATED in 1 BOTTLE (50090-4659-1) 2019-10-280000-00-00NoNoCurrent
50090-4659-25009046590290 TABLET, FILM COATED in 1 BOTTLE (50090-4659-2) 2019-10-280000-00-00NoNoCurrent
50090-4659-35009046590312 TABLET, FILM COATED in 1 BOTTLE (50090-4659-3) 2020-03-170000-00-00NoNoCurrent