DORAL (Page 4 of 4)

PRINCIPAL DISPLAY PANEL

NDC 61825-165-30
Doral (quazepam tablets, USP)
15 mg
30 Tablets
Rx Only

Label
(click image for full-size original)
DORAL
quazepam tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:61825-165
Route of Administration ORAL DEA Schedule CIV
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
QUAZEPAM (QUAZEPAM) QUAZEPAM 15 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
SODIUM LAURYL SULFATE
POWDERED CELLULOSE
STARCH, CORN
FD&C YELLOW NO. 6
LACTOSE
MAGNESIUM STEARATE
Product Characteristics
Color orange (light to medium orange) Score 2 pieces
Shape CAPSULE Size 12mm
Flavor Imprint Code 15;DORAL
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:61825-165-10 100 TABLET in 1 BOTTLE None
2 NDC:61825-165-30 30 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA018708 07/19/2017
Labeler — Galt Pharmaceuticals, LLC (079214973)

Revised: 11/2019 Galt Pharmaceuticals, LLC

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