NDC Code(s) : 69189-4186-1
Packager : Avera McKennan Hospital

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

DexamethasoneDexamethasone TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69189-4186(NDC:0054-4186)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DEXAMETHASONE(UNII: 7S5I7G3JQL)
(DEXAMETHASONE - UNII:7S5I7G3JQL) 		DEXAMETHASONE6 mg
Inactive Ingredients
Ingredient Name Strength
FD&C GREEN NO. 3(UNII: 3P3ONR6O1S)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
STARCH, CORN(UNII: O8232NY3SJ)
SUCROSE(UNII: C151H8M554)
Product Characteristics
Color TURQUOISE (Aqua) Score 2 pieces
Shape ROUND Size 6 mm
Flavor Imprint Code 54;769
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:69189-4186-11 in 1 DOSE PACK Type 0: Not a Combination Product22/06/2016
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA088316 06/22/2016

PRINCIPAL DISPLAY PANEL

Dexamethasone 6 mg tablet