Sertraline (Page 14 of 14)

PRINCIPAL DISPLAY PANEL

Sertraline Tablets, USP
50 mg/90 TabletsNDC 0143-9655-09

Sertraline Tablets, USP 50 mg/90 Tablets NDC 0143-9655-09
(click image for full-size original)

PRINCIPAL DISPLAY PANEL

Sertraline Tablets, USP
50 mg/90 TabletsNDC 0143-9655-09

Sertraline Tablets, USP 50 mg/90 Tablets NDC 0143-9655-09
(click image for full-size original)

PRINCIPAL DISPLAY PANEL

Sertraline Tablets, USP
100 mg/90 TabletsNDC 0143-9654-09

Sertraline Tablets, USP 100 mg/90 Tablets NDC 0143-9654-09
(click image for full-size original)
SERTRALINE sertraline hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0143-9656
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SERTRALINE HYDROCHLORIDE (SERTRALINE) SERTRALINE 25 mg
Inactive Ingredients
Ingredient Name Strength
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
CELLULOSE, MICROCRYSTALLINE
MAGNESIUM STEARATE
TITANIUM DIOXIDE
HYPROMELLOSE 2910 (6 MPA.S)
POLYETHYLENE GLYCOL 400
POLYSORBATE 80
D&C YELLOW NO. 10
FD&C BLUE NO. 2
SODIUM STARCH GLYCOLATE TYPE A POTATO
Product Characteristics
Color GREEN (light Green) Score 2 pieces
Shape OVAL (biconvex) Size 10mm
Flavor Imprint Code I;G;212
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0143-9656-05 500 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:0143-9656-09 90 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:0143-9656-30 30 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077864 11/06/2012 05/15/2015
SERTRALINE sertraline hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0143-9655
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SERTRALINE HYDROCHLORIDE (SERTRALINE) SERTRALINE 50 mg
Inactive Ingredients
Ingredient Name Strength
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
CELLULOSE, MICROCRYSTALLINE
MAGNESIUM STEARATE
HYPROMELLOSE 2910 (6 MPA.S)
TITANIUM DIOXIDE
POLYETHYLENE GLYCOL 400
FD&C BLUE NO. 2
POLYSORBATE 80
SODIUM STARCH GLYCOLATE TYPE A POTATO
Product Characteristics
Color BLUE (light blue) Score 2 pieces
Shape OVAL (biconvex) Size 12mm
Flavor Imprint Code I;G;213
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0143-9655-05 500 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:0143-9655-09 90 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:0143-9655-30 30 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077864 11/06/2012
SERTRALINE sertraline hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0143-9654
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SERTRALINE HYDROCHLORIDE (SERTRALINE) SERTRALINE 100 mg
Inactive Ingredients
Ingredient Name Strength
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
CELLULOSE, MICROCRYSTALLINE
MAGNESIUM STEARATE
HYPROMELLOSE 2910 (6 MPA.S)
TITANIUM DIOXIDE
POLYETHYLENE GLYCOL 400
POLYSORBATE 80
FERRIC OXIDE YELLOW
FERRIC OXIDE RED
SODIUM STARCH GLYCOLATE TYPE A POTATO
Product Characteristics
Color YELLOW (light yellow) Score 2 pieces
Shape OVAL (biconvex) Size 15mm
Flavor Imprint Code I;G;214
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0143-9654-05 500 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:0143-9654-09 90 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:0143-9654-30 30 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077864 11/06/2012 05/15/2015
Labeler — Hikma Pharmaceuticals USA Inc. (001230762)

Revised: 05/2013 Hikma Pharmaceuticals USA Inc.

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2022. All Rights Reserved.