NDC Code 42806-020-01 - Citalopram Hydrobromide

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

CITALOPRAMcitalopram TABLET, FILM COATED

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CITALOPRAM HYDROBROMIDE(UNII: I1E9D14F36) (CITALOPRAM - UNII:0DHU5B8D6V)	CITALOPRAM	10 mg

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:42806-019-30	30 in 1 BOTTLE Type 0: Not a Combination Product	20/05/2011
2	NDC:42806-019-01	100 in 1 BOTTLE Type 0: Not a Combination Product	20/05/2011
3	NDC:42806-019-05	500 in 1 BOTTLE Type 0: Not a Combination Product	20/05/2011
4	NDC:42806-019-10	1000 in 1 BOTTLE Type 0: Not a Combination Product	20/05/2011

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA077045	05/20/2011

CITALOPRAMcitalopram TABLET, FILM COATED

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CITALOPRAM HYDROBROMIDE(UNII: I1E9D14F36) (CITALOPRAM - UNII:0DHU5B8D6V)	CITALOPRAM	20 mg

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:42806-020-30	30 in 1 BOTTLE Type 0: Not a Combination Product	20/05/2011
2	NDC:42806-020-01	100 in 1 BOTTLE Type 0: Not a Combination Product	20/05/2011
3	NDC:42806-020-05	500 in 1 BOTTLE Type 0: Not a Combination Product	20/05/2011
4	NDC:42806-020-10	1000 in 1 BOTTLE Type 0: Not a Combination Product	20/05/2011

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA077045	05/20/2011

CITALOPRAMcitalopram TABLET, FILM COATED

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CITALOPRAM HYDROBROMIDE(UNII: I1E9D14F36) (CITALOPRAM - UNII:0DHU5B8D6V)	CITALOPRAM	40 mg

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:42806-021-30	30 in 1 BOTTLE Type 0: Not a Combination Product	20/05/2011
2	NDC:42806-021-01	100 in 1 BOTTLE Type 0: Not a Combination Product	20/05/2011
3	NDC:42806-021-05	500 in 1 BOTTLE Type 0: Not a Combination Product	20/05/2011
4	NDC:42806-021-10	1000 in 1 BOTTLE Type 0: Not a Combination Product	20/05/2011

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA077045	05/20/2011

LABELER - Epic Pharma, LLC(827915443)

REGISTRANT - Epic Pharma, LLC(827915443)

NDC 42806-020-01
API & Excipient Details