NDC Code(s) : 42806-019-30, 42806-019-01, 42806-019-05, 42806-019-10, 42806-020-30, 42806-020-01, 42806-020-05, 42806-020-10, 42806-021-30, 42806-021-01, 42806-021-05, 42806-021-10
Packager : Epic Pharma, LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

CITALOPRAMcitalopram TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42806-019
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CITALOPRAM HYDROBROMIDE(UNII: I1E9D14F36)
(CITALOPRAM - UNII:0DHU5B8D6V) 		CITALOPRAM10 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN(UNII: O8232NY3SJ)
HYPROMELLOSE 2208 (100 MPA.S)(UNII: B1QE5P712K)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
POLYETHYLENE GLYCOL 400(UNII: B697894SGQ)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
CROSPOVIDONE (120 .MU.M)(UNII: 68401960MK)
MAGNESIUM STEARATE(UNII: 70097M6I30)
Product Characteristics
Color WHITE Score no score
Shape OVAL Size 4 mm
Flavor Imprint Code E19
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:42806-019-3030 in 1 BOTTLE Type 0: Not a Combination Product20/05/2011
2NDC:42806-019-01100 in 1 BOTTLE Type 0: Not a Combination Product20/05/2011
3NDC:42806-019-05500 in 1 BOTTLE Type 0: Not a Combination Product20/05/2011
4NDC:42806-019-101000 in 1 BOTTLE Type 0: Not a Combination Product20/05/2011
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077045 05/20/2011
CITALOPRAMcitalopram TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42806-020
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CITALOPRAM HYDROBROMIDE(UNII: I1E9D14F36)
(CITALOPRAM - UNII:0DHU5B8D6V) 		CITALOPRAM20 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN(UNII: O8232NY3SJ)
HYPROMELLOSE 2208 (100 MPA.S)(UNII: B1QE5P712K)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
POLYETHYLENE GLYCOL 400(UNII: B697894SGQ)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
CROSPOVIDONE (120 .MU.M)(UNII: 68401960MK)
MAGNESIUM STEARATE(UNII: 70097M6I30)
Product Characteristics
Color WHITE Score no score
Shape OVAL Size 5 mm
Flavor Imprint Code E20
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:42806-020-3030 in 1 BOTTLE Type 0: Not a Combination Product20/05/2011
2NDC:42806-020-01100 in 1 BOTTLE Type 0: Not a Combination Product20/05/2011
3NDC:42806-020-05500 in 1 BOTTLE Type 0: Not a Combination Product20/05/2011
4NDC:42806-020-101000 in 1 BOTTLE Type 0: Not a Combination Product20/05/2011
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077045 05/20/2011
CITALOPRAMcitalopram TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42806-021
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)
HYPROMELLOSE 2208 (100 MPA.S)(UNII: B1QE5P712K)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
POLYETHYLENE GLYCOL 400(UNII: B697894SGQ)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
CROSPOVIDONE (120 .MU.M)(UNII: 68401960MK)
MAGNESIUM STEARATE(UNII: 70097M6I30)
Product Characteristics
Color WHITE Score no score
Shape CAPSULE Size 6 mm
Flavor Imprint Code E21
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:42806-021-3030 in 1 BOTTLE Type 0: Not a Combination Product20/05/2011
2NDC:42806-021-01100 in 1 BOTTLE Type 0: Not a Combination Product20/05/2011
3NDC:42806-021-05500 in 1 BOTTLE Type 0: Not a Combination Product20/05/2011
4NDC:42806-021-101000 in 1 BOTTLE Type 0: Not a Combination Product20/05/2011
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077045 05/20/2011

LABELER - Epic Pharma, LLC(827915443)

REGISTRANT - Epic Pharma, LLC(827915443)

Establishment
Name Address ID/FEI Business Operations
Epic Pharma, LLC 827915443 MANUFACTURE(42806-019, 42806-020, 42806-021)

PRINCIPAL DISPLAY PANEL

10mg-30ct.jpg

PRINCIPAL DISPLAY PANEL

20mg-100ct.jpg

PRINCIPAL DISPLAY PANEL

40mg-1000ct.jpg