HYDROXYCHLOROQUINE SULFATE

Product NDC
43598-131
11-digit product format
435980131
Labeler code
43598
Product ID
43598-131_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
2022-10-24
Substance
HYDROXYCHLOROQUINE SULFATE
Active strength
400 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 SULFATE400 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
43598-131-01HYDROXYCHLOROQUINE SULFATE100 in 1 BOTTLETABLET, FILM COATED10017
43598-131-05HYDROXYCHLOROQUINE SULFATE500 in 1 BOTTLETABLET, FILM COATED50017

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43598-131-01EA - Each43598-131165d87ef-19cc-4fe3-8c6a-432c219a178212023-01-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43598-131HYDROXYCHLOROQUINE 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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
43598-131-0143598013101100 TABLET, FILM COATED in 1 BOTTLE (43598-131-01) 2022-10-240000-00-00NoNoCurrent
43598-131-0543598013105500 TABLET, FILM COATED in 1 BOTTLE (43598-131-05) 2022-10-240000-00-00NoNoCurrent