Sertraline Hydrochloride (Page 10 of 10)

Package/Label Display Panel – Carton – 25 mg

25 mg Sertraline Tablets Carton
(click image for full-size original)

NDC 60687- 231 -01

Sertraline
Tablets, USP

25 mg

100 Tablets (10 x 10)                 Rx Only

HARMACIST: Dispense with Medication Guide to each patient.

Each Tablet Contains:
Sertraline hydrochloride, USP equivalent to 25 mg Sertraline.

Usual Dosage: See full prescribing information.

Store at 20° to 25°C (68° to 77°F); excursions permitted between
15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Keep this and all drugs out of reach of children.

FOR YOUR PROTECTION: Do not use if blister is torn or broken.

The drug product contained in this package is from
NDC # 69097-833, Cipla USA, Inc.

Distributed by: American Health Packaging, Columbus, Ohio 43217

723101 0423101/0923

Package/Label Display Panel – Blister – 25 mg

25 mg Sertraline Tablet Blister
(click image for full-size original)

Sertraline Tablet, USP

25 mg

Package/Label Display Panel – Carton – 50 mg

50 mg Sertraline Tablets Carton
(click image for full-size original)

NDC 60687- 242 -01

Sertraline
Tablets, USP

50 mg

100 Tablets (10 x 10)                 Rx Only

PHARMACIST: Dispense with the accompanying Medication
Guide to each patient.

Each Tablet Contains:
Sertraline hydrochloride, USP equivalent to 50 mg Sertraline.

Usual Dosage: See package insert for full prescribing information.

Store at 20° to 25°C (68° to 77°F); excursions permitted between
15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Keep this and all drugs out of the reach of children.

FOR YOUR PROTECTION: Do not use if blister is torn or broken.

The drug product contained in this package is from
NDC # 69097-834, Cipla USA, Inc.

Packaged and Distributed by:
American Health Packaging
Columbus, Ohio 43217

724201 0424201/1119

Package/Label Display Panel – Blister – 50 mg

50 mg Sertraline Tablet Blister
(click image for full-size original)

Sertraline Tablet, USP

50 mg

Package/Label Display Panel – Carton – 100 mg

100 mg Sertraline Tablets Carton
(click image for full-size original)

NDC 60687- 253 -01

Sertraline
Tablets, USP

100 mg

100 Tablets (10 x 10)                 Rx Only

PHARMACIST: Dispense with the accompanying Medication
Guide to each patient.

Each Tablet Contains:
Sertraline hydrochloride, USP equivalent to 100 mg Sertraline.

Usual Dosage: See package insert for full prescribing information.

Store at 20° to 25°C (68° to 77°F); excursions permitted between
15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Keep this and all drugs out of reach of children.

FOR YOUR PROTECTION: Do not use if blister is torn or broken.

The drug product contained in this package is from
NDC # 69097-835, Cipla USA, Inc.

Distributed by:
American Health Packaging
Columbus, Ohio 43217

725301 0425301/1218OS

Package/Label Display Panel – Blister – 100 mg

100 mg Sertraline Tablet Blister
(click image for full-size original)

Sertraline Tablet, USP

100 mg

SERTRALINE HYDROCHLORIDE sertraline hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60687-231(NDC:69097-833)
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
DIBASIC CALCIUM PHOSPHATE DIHYDRATE
HYDROXYPROPYL CELLULOSE, UNSPECIFIED
MICROCRYSTALLINE CELLULOSE
MAGNESIUM STEARATE
SODIUM STARCH GLYCOLATE TYPE A POTATO
TITANIUM DIOXIDE
HYPROMELLOSE 2910 (3 MPA.S)
HYPROMELLOSE 2910 (6 MPA.S)
POLYETHYLENE GLYCOL 400
POLYSORBATE 80
D&C YELLOW NO. 10
FD&C BLUE NO. 2
Product Characteristics
Color green (Light Green) Score 2 pieces
Shape OVAL (modified, biconvex) Size 8mm
Flavor Imprint Code 212;I;G
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:60687-231-01 100 BLISTER PACK in 1 BOX, UNIT-DOSE contains a BLISTER PACK (60687-231-11)
1 NDC:60687-231-11 1 TABLET in 1 BLISTER PACK This package is contained within the BOX, UNIT-DOSE (60687-231-01)
Image of Product
(click image for full-size original)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077397 01/30/2017
SERTRALINE HYDROCHLORIDE sertraline hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60687-242(NDC:69097-834)
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
DIBASIC CALCIUM PHOSPHATE DIHYDRATE
HYDROXYPROPYL CELLULOSE, UNSPECIFIED
MICROCRYSTALLINE CELLULOSE
MAGNESIUM STEARATE
SODIUM STARCH GLYCOLATE TYPE A POTATO
HYPROMELLOSE 2910 (3 MPA.S)
HYPROMELLOSE 2910 (6 MPA.S)
TITANIUM DIOXIDE
POLYETHYLENE GLYCOL 400
FD&C BLUE NO. 2
POLYSORBATE 80
Product Characteristics
Color blue (Light Blue) Score 2 pieces
Shape OVAL (modified, biconvex) Size 10mm
Flavor Imprint Code 213;I;G
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:60687-242-01 100 BLISTER PACK in 1 BOX, UNIT-DOSE contains a BLISTER PACK (60687-242-11)
1 NDC:60687-242-11 1 TABLET in 1 BLISTER PACK This package is contained within the BOX, UNIT-DOSE (60687-242-01)
Image of Product
(click image for full-size original)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077397 01/11/2017
SERTRALINE HYDROCHLORIDE sertraline hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60687-253(NDC:69097-835)
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
DIBASIC CALCIUM PHOSPHATE DIHYDRATE
HYDROXYPROPYL CELLULOSE, UNSPECIFIED
MICROCRYSTALLINE CELLULOSE
MAGNESIUM STEARATE
SODIUM STARCH GLYCOLATE TYPE A POTATO
HYPROMELLOSE 2910 (3 MPA.S)
HYPROMELLOSE 2910 (6 MPA.S)
TITANIUM DIOXIDE
POLYETHYLENE GLYCOL 400
POLYSORBATE 80
FERRIC OXIDE YELLOW
FERRIC OXIDE RED
Product Characteristics
Color yellow (Light Yellow) Score 2 pieces
Shape OVAL (modified, biconvex) Size 13mm
Flavor Imprint Code 214;I;G
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:60687-253-01 100 BLISTER PACK in 1 BOX, UNIT-DOSE contains a BLISTER PACK (60687-253-11)
1 NDC:60687-253-11 1 TABLET in 1 BLISTER PACK This package is contained within the BOX, UNIT-DOSE (60687-253-01)
Image of Product
(click image for full-size original)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077397 06/19/2017
Labeler — American Health Packaging (929561009)
Establishment
Name Address ID/FEI Operations
American Health Packaging 929561009 repack (60687-231), repack (60687-242), repack (60687-253)

Revised: 10/2023 American Health Packaging

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