HYDROXYCHLOROQUINE SULFATE

Product NDC
59651-889
11-digit product format
596510889
Labeler code
59651
Product ID
59651-889_e6f889ff-c5ba-4324-b87c-ec3ac942be2f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
HYDROXYCHLOROQUINE SULFATE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA040274
Marketing category
ANDA
Marketing start
2025-03-07
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59651-889-01HYDROXYCHLOROQUINE SULFATE100 in 1 BOTTLE, PLASTICTABLET, FILM COATED1001
59651-889-05HYDROXYCHLOROQUINE SULFATE500 in 1 BOTTLE, PLASTICTABLET, FILM COATED5001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59651-889-01EA - Each59651-88916e4707b-ec97-46aa-848d-8bcaa39485bc12025-06-13
59651-889-05EA - Each59651-889e6280781-3830-4fa1-ad3e-581cf05c0fd612025-06-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59651-889HYDROXYCHLOROQUINE SULFATE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]1Current NDC, 2 package rows20250312_e6f889ff-c5ba-4324-b87c-ec3ac942be2f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
979092hydroxychloroquine sulfate 200 MG Oral TabletPSNe6f889ff-c5ba-4324-b87c-ec3ac942be2f1
979092hydroxychloroquine sulfate 200 MG Oral TabletSCDe6f889ff-c5ba-4324-b87c-ec3ac942be2f1
979092hydroxychloroquine sulfate 200 MG (as hydroxychloroquine 155 MG) Oral TabletSYe6f889ff-c5ba-4324-b87c-ec3ac942be2f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
59651-889-0159651088901100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (59651-889-01) 2025-03-07NoNoCurrent
59651-889-0559651088905500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (59651-889-05) 2025-03-07NoNoCurrent