Minds On Meds

Mental Health Medications

Antidepressants

Zoloft, Page 8

Zoloft (sertraline hydrochloride) is indicated for the treatment of major depressive disorder, OCD, panic disorder, PTSD, premenstrual dysphoric disorder, and social anxiety disorder. Concomitant use in patients taking monoamine oxidase inhibitors (MAOIs) is contraindicated.

PRINCIPAL DISPLAY PANEL — 25 mg Tablet Bottle Label

ALWAYS DISPENSE WITH MEDICATION GUIDE

NDC 0049-4960-30

30 Tablets
Rx only

Zoloft®
(sertraline HCl)

25 mg*

Pfizer
Roerig
Division of Pfizer Inc, NY, NY 10017

PRINCIPAL DISPLAY PANEL -- 25 mg Tablet Bottle Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 50 mg Tablet Bottle Label

ALWAYS DISPENSE WITH MEDICATION GUIDE

NDC 0049-4900-30

30 Tablets
Rx only

Zoloft®
(sertraline HCl)

50 mg*

Pfizer
Roerig
Division of Pfizer Inc, NY, NY 10017

PRINCIPAL DISPLAY PANEL -- 50 mg Tablet Bottle Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 100 mg Tablet Bottle Label

ALWAYS DISPENSE WITH MEDICATION GUIDE

NDC 0049-4910-30

30 Tablets
Rx only

Zoloft®
(sertraline HCl)

100 mg*

Pfizer
Roerig
Division of Pfizer Inc, NY, NY 10017

PRINCIPAL DISPLAY PANEL -- 100 mg Tablet Bottle Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 60 mL Bottle Label

ALWAYS DISPENSE WITH MEDICATION GUIDE

60 mL
Rx only

Zoloft®
(sertraline HCl)

ORAL CONCENTRATE

equivalent to
20 mg/mL*
of sertraline

Pfizer
Roerig
Division of Pfizer Inc, NY, NY 10017

PRINCIPAL DISPLAY PANEL- 30 Tablet Bottle Label
(click image for full-size original)
ZOLOFT
sertraline hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0049-4960
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
sertraline hydrochloride (sertraline) sertraline hydrochloride 25 mg
Inactive Ingredients
Ingredient Name Strength
dibasic calcium phosphate dihydrate
D&C YELLOW NO. 10
FD&C BLUE NO. 1
FD&C RED NO. 40
hydroxypropyl cellulose
hypromelloses
magnesium stearate
cellulose, microcrystalline
polyethylene glycol
polysorbate 80
titanium dioxide
aluminum oxide
Product Characteristics
Color GREEN (light green) Score 2 pieces
Shape OVAL (CAPSULE-SHAPED) Size 8mm
Flavor Imprint Code ZOLOFT;25;mg
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0049-4960-30 30 TABLET, FILM COATED (TABLET) in 1 BOTTLE None
2 NDC:0049-4960-50 50 TABLET, FILM COATED (TABLET) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA019839 02/11/1992
ZOLOFT
sertraline hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0049-4900
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
sertraline hydrochloride (sertraline) sertraline hydrochloride 50 mg
Inactive Ingredients
Ingredient Name Strength
dibasic calcium phosphate dihydrate
FD&C BLUE NO. 2
hydroxypropyl cellulose
hypromelloses
magnesium stearate
cellulose, microcrystalline
polyethylene glycol
polysorbate 80
titanium dioxide
aluminum oxide
Product Characteristics
Color BLUE (light blue) Score 2 pieces
Shape OVAL (CAPSULE-SHAPED) Size 10mm
Flavor Imprint Code ZOLOFT;50;mg
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0049-4900-30 30 TABLET, FILM COATED (TABLET) in 1 BOTTLE None
2 NDC:0049-4900-66 100 TABLET, FILM COATED (TABLET) in 1 BOTTLE None
3 NDC:0049-4900-73 500 TABLET, FILM COATED (TABLET) in 1 BOTTLE None
4 NDC:0049-4900-94 5000 TABLET, FILM COATED (TABLET) in 1 BOTTLE None
5 NDC:0049-4900-41 100 TABLET, FILM COATED (TABLET) in 1 DOSE PACK None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA019839 02/11/1992
ZOLOFT
sertraline hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0049-4910
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
sertraline hydrochloride (sertraline) sertraline hydrochloride 100 mg
Inactive Ingredients
Ingredient Name Strength
dibasic calcium phosphate dihydrate
hydroxypropyl cellulose
hypromelloses
magnesium stearate
cellulose, microcrystalline
polyethylene glycol
polysorbate 80
ferric oxide yellow
titanium dioxide
Product Characteristics
Color YELLOW (light yellow) Score 2 pieces
Shape OVAL (CAPSULE-SHAPED) Size 13mm
Flavor Imprint Code ZOLOFT;100;mg
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0049-4910-30 30 TABLET, FILM COATED (TABLET) in 1 BOTTLE None
2 NDC:0049-4910-66 100 TABLET, FILM COATED (TABLET) in 1 BOTTLE None
3 NDC:0049-4910-73 500 TABLET, FILM COATED (TABLET) in 1 BOTTLE None
4 NDC:0049-4910-94 5000 TABLET, FILM COATED (TABLET) in 1 BOTTLE None
5 NDC:0049-4910-41 100 TABLET, FILM COATED (TABLET) in 1 DOSE PACK None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA019839 02/11/1992
ZOLOFT
sertraline hydrochloride solution, concentrate
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0049-4940
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
sertraline hydrochloride (sertraline) sertraline hydrochloride 20 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
glycerin
alcohol
menthol
butylated hydroxytoluene
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0049-4940-23 60 mL in 1 BOTTLE, DROPPER None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020990 02/11/1992
Labeler — Roerig (829076996)
Establishment
Name Address ID/FEI Operations
Pfizer Ireland Pharmaceuticals 896090987 MANUFACTURE
Establishment
Name Address ID/FEI Operations
Aurobindo Pharma Limited 918917662 MANUFACTURE
Establishment
Name Address ID/FEI Operations
Finorga S.A.S. 640422218 API MANUFACTURE
Establishment
Name Address ID/FEI Operations
Finorga S.A.S. 276669694 API MANUFACTURE
Establishment
Name Address ID/FEI Operations
Pfizer Pharmaceuticals LLC 829084545 MANUFACTURE
Establishment
Name Address ID/FEI Operations
Pfizer Pharmaceuticals LLC 193684656 MANUFACTURE
Establishment
Name Address ID/FEI Operations
Pfizer Pharmaceuticals LLC 829084552 MANUFACTURE
Establishment
Name Address ID/FEI Operations
Phamacia and Upjohn Company 829076566 MANUFACTURE
Establishment
Name Address ID/FEI Operations
Warner Lambert Company LLC 001344506 MANUFACTURE

Revised: 04/2011 Roerig