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 — 50 mg Tablet Bottle Label

ALWAYS DISPENSE WITH MEDICATION GUIDE

sertraline HCl tablets

50 mg*

Rx only

PRINCIPAL DISPLAY PANEL — 100 mg Tablet Bottle Label

ALWAYS DISPENSE WITH MEDICATION GUIDE

sertraline HCl tablets

100 mg*

Rx only

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.