Hydroxychloroquine Sulfate

Basic Information

Product Name

FDA Product Code

53808-1112

Regulatory Information

NDC Product Code

53808-1112

Application Number

ANDA040766

Marketing Category

C73584

Effective Date

January 29, 2019

Territorial Authority

USA

FDA Title

Hydroxychloroquine Sulfate Tablets, USP

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

Active Ingredients

HYDROXYCHLOROQUINE SULFATE

Quantity: 200 mg in 1 1

Code: 8Q2869CNVH

Class Code: ACTIB

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

ANHYDROUS DIBASIC CALCIUM PHOSPHATE

Code: L11K75P92J

Class Code: IACT

HYPROMELLOSE, UNSPECIFIED

Code: 3NXW29V3WO

Class Code: IACT

POLYETHYLENE GLYCOL 3350

Code: G2M7P15E5P

Class Code: IACT

SILICON DIOXIDE

Code: ETJ7Z6XBU4

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

STARCH, CORN

Code: O8232NY3SJ

Class Code: IACT

TALC

Code: 7SEV7J4R1U

Class Code: IACT

POLYSORBATE 80

Code: 6OZP39ZG8H

Class Code: IACT

Active Moieties