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

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
8Q2869CNVHHYDROXYCHLOROQUINE SULFATE747-36-4HYDROXYCHLOROQUINE SULFATE

Packages

Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
59651-889-0159651088901100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (59651-889-01) 2025-03-07NoNoHistorical
59651-889-0559651088905500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (59651-889-05) 2025-03-07NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
HYDROXYCHLOROQUINE SULFATEAurobindo Pharma Limited | APL HEALTHCARE LIMITED2025-03-11Human Prescription Drug Label1