NDC Code(s) : 69844-033-01, 69844-033-02, 69844-033-03, 69844-034-01, 69844-034-02, 69844-034-03, 69844-035-01, 69844-035-02, 69844-035-03
Packager : Graviti Pharmaceuticals Private Limited

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

ESCITALOPRAMESCITALOPRAM OXALATE TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69844-033
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ESCITALOPRAM OXALATE(UNII: 5U85DBW7LO)
(ESCITALOPRAM - UNII:4O4S742ANY) 		ESCITALOPRAM5 mg
Inactive Ingredients
Ingredient Name Strength
BUTYLATED HYDROXYANISOLE(UNII: REK4960K2U)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
HYDROXYPROPYL CELLULOSE (1600000 WAMW)(UNII: RFW2ET671P)
HYPROMELLOSES(UNII: 3NXW29V3WO)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 6 mm
Flavor Imprint Code APO;ESC;5
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:69844-033-0130 in 1 BOTTLE Type 0: Not a Combination Product14/11/2019
2NDC:69844-033-02100 in 1 BOTTLE Type 0: Not a Combination Product14/11/2019
3NDC:69844-033-031000 in 1 BOTTLE Type 0: Not a Combination Product14/11/2019
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078777 11/14/2019
ESCITALOPRAMESCITALOPRAM OXALATE TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69844-034
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ESCITALOPRAM OXALATE(UNII: 5U85DBW7LO)
(ESCITALOPRAM - UNII:4O4S742ANY) 		ESCITALOPRAM10 mg
Inactive Ingredients
Ingredient Name Strength
BUTYLATED HYDROXYANISOLE(UNII: REK4960K2U)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
HYDROXYPROPYL CELLULOSE (1600000 WAMW)(UNII: RFW2ET671P)
HYPROMELLOSES(UNII: 3NXW29V3WO)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Product Characteristics
Color WHITE Score 2 pieces
Shape ROUND Size 7 mm
Flavor Imprint Code APO;ESC;10
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:69844-034-0130 in 1 BOTTLE Type 0: Not a Combination Product14/11/2019
2NDC:69844-034-02100 in 1 BOTTLE Type 0: Not a Combination Product14/11/2019
3NDC:69844-034-031000 in 1 BOTTLE Type 0: Not a Combination Product14/11/2019
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078777 11/14/2019
ESCITALOPRAMESCITALOPRAM OXALATE TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69844-035
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ESCITALOPRAM OXALATE(UNII: 5U85DBW7LO)
(ESCITALOPRAM - UNII:4O4S742ANY) 		ESCITALOPRAM20 mg
Inactive Ingredients
Ingredient Name Strength
BUTYLATED HYDROXYANISOLE(UNII: REK4960K2U)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
HYDROXYPROPYL CELLULOSE (1600000 WAMW)(UNII: RFW2ET671P)
HYPROMELLOSES(UNII: 3NXW29V3WO)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Product Characteristics
Color WHITE Score 2 pieces
Shape ROUND Size 10 mm
Flavor Imprint Code APO;ESC;20
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:69844-035-0130 in 1 BOTTLE Type 0: Not a Combination Product14/11/2019
2NDC:69844-035-02100 in 1 BOTTLE Type 0: Not a Combination Product14/11/2019
3NDC:69844-035-031000 in 1 BOTTLE Type 0: Not a Combination Product14/11/2019
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078777 11/14/2019

LABELER - Graviti Pharmaceuticals Private Limited(650884781)

REGISTRANT - Graviti Pharmaceuticals Private Limited(650884781)

Establishment
Name Address ID/FEI Business Operations
Graviti Pharmaceuticals Private Limited 650884781 MANUFACTURE(69844-033, 69844-034, 69844-035), ANALYSIS(69844-033, 69844-034, 69844-035)

PRINCIPAL DISPLAY PANEL

NDC 69844-033-01

Escitalopram Tablets, USP

5 mg

PHARMACIST: Dispense the enclosed Medication Guide to each patient.

Rx Only

30 Tablets

image

PRINCIPAL DISPLAY PANEL

NDC 69844-034-01

Escitalopram Tablets, USP

10 mg

PHARMACIST: Dispense the enclosed Medication Guide to each patient.

Rx Only

30 Tablets

image

PRINCIPAL DISPLAY PANEL

NDC 69844-035-01

Escitalopram Tablets, USP

20 mg

PHARMACIST: Dispense the enclosed Medication Guide to each patient.

Rx Only

30 Tablets

image