Escitalopram (Page 9 of 9)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 69844-077 -01

Escitalopram Tablets, USP

5 mg

PHARMACIST: Dispense the Medication Guide provided separately to each patient.

Rx Only

30 Tablets

image
(click image for full-size original)

NDC 69844-078 -01

Escitalopram Tablets, USP

10 mg

PHARMACIST: Dispense the Medication Guide provided separately to each patient.

Rx Only

30 Tablets

image
(click image for full-size original)

NDC 69844-079 -01

Escitalopram Tablets, USP

20 mg

PHARMACIST: Dispense the Medication Guide provided separately to each patient.

Rx Only

30 Tablets

image
(click image for full-size original)
ESCITALOPRAM escitalopram tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69844-077
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ESCITALOPRAM OXALATE (ESCITALOPRAM) ESCITALOPRAM 5 mg
Inactive Ingredients
Ingredient Name Strength
BUTYLATED HYDROXYANISOLE
CELLULOSE, MICROCRYSTALLINE
CROSCARMELLOSE SODIUM
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
HYPROMELLOSES
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL, UNSPECIFIED
TITANIUM DIOXIDE
Product Characteristics
Color WHITE Score no score
Shape ROUND (biconvex) Size 6mm
Flavor Imprint Code 77
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69844-077-01 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:69844-077-02 100 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:69844-077-03 1000 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078777 05/31/2023
ESCITALOPRAM escitalopram tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69844-078
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ESCITALOPRAM OXALATE (ESCITALOPRAM) ESCITALOPRAM 10 mg
Inactive Ingredients
Ingredient Name Strength
BUTYLATED HYDROXYANISOLE
CELLULOSE, MICROCRYSTALLINE
CROSCARMELLOSE SODIUM
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
HYPROMELLOSES
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL, UNSPECIFIED
TITANIUM DIOXIDE
Product Characteristics
Color WHITE Score 2 pieces
Shape ROUND (biconvex) Size 7mm
Flavor Imprint Code 74
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69844-078-01 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:69844-078-02 100 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:69844-078-03 1000 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078777 05/31/2023
ESCITALOPRAM escitalopram tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69844-079
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ESCITALOPRAM OXALATE (ESCITALOPRAM) ESCITALOPRAM 20 mg
Inactive Ingredients
Ingredient Name Strength
BUTYLATED HYDROXYANISOLE
CELLULOSE, MICROCRYSTALLINE
CROSCARMELLOSE SODIUM
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
HYPROMELLOSES
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL, UNSPECIFIED
TITANIUM DIOXIDE
Product Characteristics
Color WHITE Score 2 pieces
Shape ROUND (biconvex) Size 10mm
Flavor Imprint Code 71
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69844-079-01 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:69844-079-02 100 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:69844-079-03 1000 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078777 05/31/2023
Labeler — Graviti Pharmaceuticals Private Limited (650884781)
Registrant — Graviti Pharmaceuticals Private Limited (650884781)
Establishment
Name Address ID/FEI Operations
Graviti Pharmaceuticals Private Limited 650884781 MANUFACTURE (69844-077), MANUFACTURE (69844-078), MANUFACTURE (69844-079), ANALYSIS (69844-077), ANALYSIS (69844-078), ANALYSIS (69844-079)

Revised: 05/2023 Graviti Pharmaceuticals Private Limited

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