FDA.reportPublic FDA data

HYDROXYCHLOROQUINE SULFATE

Product NDC
43598-721
11-digit product format
435980721
Labeler code
43598
Product ID
43598-721_45c22bbf-6332-4f7f-b77e-8ac613435821
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
HYDROXYCHLOROQUINE SULFATE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Dr. Reddy's Laboratories Inc.
Application
ANDA210441
Marketing category
ANDA
Marketing start
2018-05-01
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, 1119312, 2569281, 2569283

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43598-721-01HYDROXYCHLOROQUINE SULFATE100 in 1 BOTTLETABLET, FILM COATED10017
43598-721-05HYDROXYCHLOROQUINE SULFATE500 in 1 BOTTLETABLET, FILM COATED50017

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43598-721-01EA - Each43598-721bc9019ee-0d35-4b2f-b6e8-8ebbd066e45812018-08-13
43598-721-05EA - Each43598-72155321b6e-ba49-4a85-a4f6-881c65b01f3512018-08-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43598-721HYDROXYCHLOROQUINE SULFATE TABLET [DR. REDDY'S LABORATORIES INC.]15Current NDC, Legacy NDC, 2 package rows20240625_452092b4-7a8f-4d19-8113-f1c2a948d3d8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2569281hydroxychloroquine sulfate 100 MG Oral TabletPSN452092b4-7a8f-4d19-8113-f1c2a948d3d817
979092hydroxychloroquine sulfate 200 MG Oral TabletPSN452092b4-7a8f-4d19-8113-f1c2a948d3d817
2569283hydroxychloroquine sulfate 300 MG Oral TabletPSN452092b4-7a8f-4d19-8113-f1c2a948d3d817
1119312hydroxychloroquine sulfate 400 MG Oral TabletPSN452092b4-7a8f-4d19-8113-f1c2a948d3d817
2569281hydroxychloroquine sulfate 100 MG Oral TabletSCD452092b4-7a8f-4d19-8113-f1c2a948d3d817
979092hydroxychloroquine sulfate 200 MG Oral TabletSCD452092b4-7a8f-4d19-8113-f1c2a948d3d817
2569283hydroxychloroquine sulfate 300 MG Oral TabletSCD452092b4-7a8f-4d19-8113-f1c2a948d3d817
1119312hydroxychloroquine sulfate 400 MG Oral TabletSCD452092b4-7a8f-4d19-8113-f1c2a948d3d817
979092hydroxychloroquine sulfate 200 MG (as hydroxychloroquine 155 MG) Oral TabletSY452092b4-7a8f-4d19-8113-f1c2a948d3d817
979092hydroxychloroquine sulfate 200 MG Oral TabletPSNebe00e35-ed3d-40f4-9a93-a37b0da01ddb7
979092hydroxychloroquine sulfate 200 MG Oral TabletSCDebe00e35-ed3d-40f4-9a93-a37b0da01ddb7
979092hydroxychloroquine sulfate 200 MG (as hydroxychloroquine 155 MG) Oral TabletSYebe00e35-ed3d-40f4-9a93-a37b0da01ddb7
979092hydroxychloroquine sulfate 200 MG Oral TabletPSNa5b3455a-e842-7d4b-e053-2995a90adee34
979092hydroxychloroquine sulfate 200 MG Oral TabletSCDa5b3455a-e842-7d4b-e053-2995a90adee34
979092hydroxychloroquine sulfate 200 MG (as hydroxychloroquine 155 MG) Oral TabletSYa5b3455a-e842-7d4b-e053-2995a90adee34
979092hydroxychloroquine sulfate 200 MG Oral TabletPSNbeff29fe-574f-4566-99ac-53ec3b3038a72
979092hydroxychloroquine sulfate 200 MG Oral TabletSCDbeff29fe-574f-4566-99ac-53ec3b3038a72
979092hydroxychloroquine sulfate 200 MG (as hydroxychloroquine 155 MG) Oral TabletSYbeff29fe-574f-4566-99ac-53ec3b3038a72

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
43598-721-0143598072101100 TABLET, FILM COATED in 1 BOTTLE (43598-721-01) 2018-05-010000-00-00NoNoCurrent
43598-721-0543598072105500 TABLET, FILM COATED in 1 BOTTLE (43598-721-05) 2018-05-010000-00-00NoNoCurrent