SERTRALINE HYDROCHLORIDE (Page 16 of 16)

PRINCIPAL DISPLAY PANEL — 25 mg Tablet Bottle Label

ALWAYS DISPENSE WITH MEDICATION GUIDE


sertraline HCl tablets

25 mg*

Rx only

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


sertraline HCl tablets

50 mg*

Rx only

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


sertraline HCl tablets

100 mg*

Rx only

Principal Display Panel -- 100 mg Tablet Bottle Label
(click image for full-size original)
SERTRALINE HYDROCHLORIDE sertraline hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54868-5658(NDC:59762-4960)
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
D&C YELLOW NO. 10
FD&C BLUE NO. 1
FD&C RED NO. 40
ALUMINUM OXIDE
HYDROXYPROPYL CELLULOSE (TYPE H)
HYPROMELLOSES
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOLS
POLYSORBATE 80
TITANIUM DIOXIDE
Product Characteristics
Color GREEN (light green) Score 2 pieces
Shape OVAL (CAPSULE-SHAPED) Size 8mm
Flavor Imprint Code G;4960;25;mg
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54868-5658-0 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:54868-5658-1 60 TABLET, FILM COATED (TABLET) in 1 BOTTLE None
3 NDC:54868-5658-2 90 TABLET, FILM COATED (TABLET) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA AUTHORIZED GENERIC NDA019839 08/16/2006
SERTRALINE HYDROCHLORIDE sertraline hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54868-5639(NDC:59762-4900)
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
FD&C BLUE NO. 2
ALUMINUM OXIDE
HYDROXYPROPYL CELLULOSE (TYPE H)
HYPROMELLOSES
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOLS
POLYSORBATE 80
TITANIUM DIOXIDE
Product Characteristics
Color BLUE (light blue) Score 2 pieces
Shape OVAL (CAPSULE-SHAPED) Size 10mm
Flavor Imprint Code G;4900;50;mg
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54868-5639-0 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:54868-5639-1 45 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:54868-5639-2 10 TABLET, FILM COATED in 1 BOTTLE None
4 NDC:54868-5639-5 90 TABLET, FILM COATED in 1 BOTTLE None
5 NDC:54868-5639-6 60 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA AUTHORIZED GENERIC NDA019839 08/24/2006
SERTRALINE HYDROCHLORIDE sertraline hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54868-5638(NDC:59762-4910)
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 (TYPE H)
HYPROMELLOSES
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOLS
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 G;4910;100;mg
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54868-5638-0 60 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:54868-5638-1 30 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:54868-5638-5 100 TABLET, FILM COATED in 1 BOTTLE None
4 NDC:54868-5638-6 90 TABLET, FILM COATED in 1 BOTTLE None
5 NDC:54868-5638-7 180 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA AUTHORIZED GENERIC NDA019839 09/12/2006
Labeler — Physicians Total Care, Inc. (194123980)
Establishment
Name Address ID/FEI Operations
Physicians Total Care, Inc. 194123980 relabel (54868-5658), repack (54868-5658), relabel (54868-5639), repack (54868-5639), relabel (54868-5638), repack (54868-5638)

Revised: 02/2014 Physicians Total Care, Inc.

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