Hydroxychloroquine Sulfate

HYDROXYCHLOROQUINE SULFATE- hydroxychloroquine sulfate tablet, film coated
Cadila Healthcare Limited

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 65841-633-01 in bottle of 100 tablets

Hydroxychloroquine Sulfate Tablets USP, 200 mg

Rx only

100 tablets

Hydroxychloroquine sulfate tablets
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HYDROXYCHLOROQUINE SULFATE
hydroxychloroquine sulfate tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-633
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HYDROXYCHLOROQUINE SULFATE (HYDROXYCHLOROQUINE) HYDROXYCHLOROQUINE SULFATE 200 mg
Inactive Ingredients
Ingredient Name Strength
DIBASIC CALCIUM PHOSPHATE DIHYDRATE
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL, UNSPECIFIED
POLYVINYL ALCOHOL, UNSPECIFIED
TALC
TITANIUM DIOXIDE
STARCH, CORN
Product Characteristics
Color WHITE (WHITE TO OFF-WHITE) Score no score
Shape OVAL (CAPSULE) Size 13mm
Flavor Imprint Code ZC38
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65841-633-01 100 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:65841-633-05 500 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:65841-633-30 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK
3 10 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (65841-633-30)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040657 01/03/2008
Labeler — Cadila Healthcare Limited (918596198)
Registrant — Cadila Healthcare Limited (918596198)
Establishment
Name Address ID/FEI Operations
Cadila Healthcare Limited 918596198 ANALYSIS (65841-633), MANUFACTURE (65841-633)

Revised: 04/2020 Cadila Healthcare Limited

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