NDC Code(s) : 43063-221-30
Packager : PD-Rx Pharmaceuticals, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

citalopram hydrobromidecitalopram hydrobromide TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43063-221(NDC:57664-509)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CITALOPRAM HYDROBROMIDE(UNII: I1E9D14F36)
(CITALOPRAM - UNII:0DHU5B8D6V) 		CITALOPRAM40 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN(UNII: O8232NY3SJ)
COPOVIDONE K25-31(UNII: D9C330MD8B)
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
HYPROMELLOSE 2910 (6 MPA.S)(UNII: 0WZ8WG20P6)
POLYETHYLENE GLYCOL 4000(UNII: 4R4HFI6D95)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
Product Characteristics
Color white Score 2 pieces
Shape OVAL Size 13 mm
Flavor Imprint Code 509
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:43063-221-3030 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product06/01/2015
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077032 05/29/2015

PRINCIPAL DISPLAY PANEL

Citalopram Tablets-40mg

43063221 Label