Hydroxychloroquine sulfate

Product NDC
71610-506
11-digit product format
716100506
Labeler code
71610
Product ID
71610-506_2027b984-d53d-41c0-914b-ff66535e0e51
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydroxychloroquine sulfate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA040657
Marketing category
ANDA
Marketing start
2008-01-03
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
71610-506-307161005063030 TABLET, FILM COATED in 1 BOTTLE (71610-506-30) 2020-12-22NoNoHistorical
71610-506-537161005065360 TABLET, FILM COATED in 1 BOTTLE (71610-506-53) 2020-12-22NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Hydroxychloroquine sulfate tablets, USPAphena Pharma Solutions - Tennessee, LLC2020-12-22HUMAN PRESCRIPTION DRUG LABEL1