Hydroxychloroquine sulfate

Basic Information

Product Name

FDA Product Code

50090-6629

Regulatory Information

NDC Product Code

50090-6629

Application Number

ANDA040657

Marketing Category

C73584

Effective Date

August 26, 2023

Territorial Authority

USA

FDA Title

These highlights do not include all the information needed to use HYDROXYCHLOROQUINE SULFATE TABLETS safely and effectively. See full prescribing information for HYDROXYCHLOROQUINE SULFATE TABLETS. HYDROXYCHLOROQUIN SULFATE tablets, for oral use Initial U.S. Approval: 1955

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

Active Ingredients

DIBASIC CALCIUM PHOSPHATE DIHYDRATE

Code: O7TSZ97GEP

Class Code: IACT

HYDROXYCHLOROQUINE SULFATE

Quantity: 200 mg in 1 1

Code: 8Q2869CNVH

Class Code: ACTIB

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

POLYETHYLENE GLYCOL, UNSPECIFIED

Code: 3WJQ0SDW1A

Class Code: IACT

POLYVINYL ALCOHOL, UNSPECIFIED

Code: 532B59J990

Class Code: IACT

TALC

Code: 7SEV7J4R1U

Class Code: IACT

STARCH, CORN

Code: O8232NY3SJ

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

Active Moieties