NDC Code(s) : 24987-562-10, 24987-562-20
Packager : Covis Pharmaceuticals Inc

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

PlaquenilHydroxychloroquine Sulfate TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:24987-562
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
hydroxychloroquine sulfate(UNII: 8Q2869CNVH)
(hydroxychloroquine - UNII:4QWG6N8QKH) 		hydroxychloroquine sulfate200 mg
Inactive Ingredients
Ingredient Name Strength
Calcium Phosphate, Dibasic, Anhydrous(UNII: L11K75P92J)
Hypromelloses(UNII: 3NXW29V3WO)
Magnesium Stearate(UNII: 70097M6I30)
Polyethylene glycol 400(UNII: B697894SGQ)
Polysorbate 80(UNII: 6OZP39ZG8H)
Starch, Corn(UNII: O8232NY3SJ)
Titanium Dioxide(UNII: 15FIX9V2JP)
Product Characteristics
Color WHITE Score no score
Shape DOUBLE CIRCLE (peanut shaped) Size 12 mm
Flavor Imprint Code PLAQUENIL
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:24987-562-10100 in 1 BOTTLE
2NDC:24987-562-20100 in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA009768 06/28/2013

PRINCIPAL DISPLAY PANEL

NDC 24987-562-10
Rx only

Plaquenil®
hydroxychloroquine
sulfate, USP
200 mg

100 tablets

KEEP OUT OF THE REACH OF CHILDREN

Dispense in a tight, light-resistant container
as defined in the USP/NF.

COVIS

Mfd. for: Covis Pharmaceuticals, Inc.
Cary, NC 27511

©2013 Covis Pharmaceuticals, Inc. 50106153
Origin France Rev. 5/13 100117

Store at room temperature up to 30° C (86°F).
For indications and dosage, see package insert.
PHARMACIST: Children are especially sensitive to this medication. Tablets should be kept out of their reach.

Bottle LabelBottle Label

PRINCIPAL DISPLAY PANEL

GOVERNMENT USE ONLY

NDC 24987-562-20
Rx only

Plaquenil®
hydroxychloroquine
sulfate, USP
200 mg

100 tablets

KEEP OUT OF THE REACH OF CHILDREN

Dispense in a tight, light-resistant container
as defined in the USP/NF.

COVIS

Mfd. for: Covis Pharmaceuticals, Inc.
Cary, NC 27511

©2013 Covis Pharmaceuticals, Inc. 50106158
Origin France Rev. 5/13 100119

Store at room temperature up to 30° C (86°F).
For indications and dosage, see package insert.
PHARMACIST: Children are especially sensitive to this medication. Tablets should be kept out of their reach.

Bottle LabelBottle Label