NDC Code(s) : 0378-8011-01, 0378-8011-05, 0378-8121-01, 0378-8121-05, 0378-8127-01, 0378-8127-05
Packager : Mylan Pharmaceuticals Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Sertraline Hydrochloridesertraline TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0378-8011
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SERTRALINE HYDROCHLORIDE(UNII: UTI8907Y6X)
(SERTRALINE - UNII:QUC7NX6WMB) 		SERTRALINE25 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
COPOVIDONE(UNII: D9C330MD8B)
ANHYDROUS DIBASIC CALCIUM PHOSPHATE(UNII: L11K75P92J)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
POLYDEXTROSE(UNII: VH2XOU12IE)
POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
SODIUM STARCH GLYCOLATE TYPE A POTATO(UNII: 5856J3G2A2)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
TRIACETIN(UNII: XHX3C3X673)
Product Characteristics
Color WHITE Score 2 pieces
Shape ROUND Size 6 mm
Flavor Imprint Code S;21
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0378-8011-01100 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product29/05/2013
2NDC:0378-8011-05500 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product29/05/2013
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078626 05/29/2013 03/31/2019
Sertraline Hydrochloridesertraline TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0378-8121
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SERTRALINE HYDROCHLORIDE(UNII: UTI8907Y6X)
(SERTRALINE - UNII:QUC7NX6WMB) 		SERTRALINE50 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
COPOVIDONE(UNII: D9C330MD8B)
ANHYDROUS DIBASIC CALCIUM PHOSPHATE(UNII: L11K75P92J)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
POLYDEXTROSE(UNII: VH2XOU12IE)
POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
SODIUM STARCH GLYCOLATE TYPE A POTATO(UNII: 5856J3G2A2)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
TRIACETIN(UNII: XHX3C3X673)
FD&C BLUE NO. 2(UNII: L06K8R7DQK)
Product Characteristics
Color BLUE Score 2 pieces
Shape ROUND Size 8 mm
Flavor Imprint Code S;121
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0378-8121-01100 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product29/05/2013
2NDC:0378-8121-05500 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product29/05/2013
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078626 05/29/2013 03/31/2019
Sertraline Hydrochloridesertraline TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0378-8127
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SERTRALINE HYDROCHLORIDE(UNII: UTI8907Y6X)
(SERTRALINE - UNII:QUC7NX6WMB) 		SERTRALINE100 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
COPOVIDONE(UNII: D9C330MD8B)
ANHYDROUS DIBASIC CALCIUM PHOSPHATE(UNII: L11K75P92J)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
POLYDEXTROSE(UNII: VH2XOU12IE)
POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
SODIUM STARCH GLYCOLATE TYPE A POTATO(UNII: 5856J3G2A2)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
TRIACETIN(UNII: XHX3C3X673)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
Product Characteristics
Color YELLOW Score 2 pieces
Shape ROUND Size 11 mm
Flavor Imprint Code S;127
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0378-8127-01100 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product29/05/2013
2NDC:0378-8127-05500 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product18/05/2012
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078626 05/18/2012 10/31/2018

PRINCIPAL DISPLAY PANEL

NDC 0378-8011-01

Sertraline
Hydrochloride
Tablets, USP
25 mg

PHARMACIST: Dispense the accompanying
Medication Guide to each patient.

Rx only 100 Tablets

Each film-coated tablet contains
sertraline hydrochloride, USP
equivalent to 25 mg of sertraline.

Dispense in a tight, light-resistant
container as defined in the USP
using a child-resistant closure.

Keep container tightly closed.

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

Store at 20° to 25°C (68° to 77°F).
[See USP Controlled Room
Temperature.]

Usual Dosage: See accompanying
prescribing information.

Mylan Pharmaceuticals Inc.
Morgantown, WV 26505 U.S.A.

Mylan.com

RM8011A5

Sertraline Hydrochloride Tablets, USP 25 mg Bottle Label

PRINCIPAL DISPLAY PANEL

NDC 0378-8121-01

Sertraline
Hydrochloride
Tablets, USP
50 mg

PHARMACIST: Dispense the accompanying
Medication Guide to each patient.

Rx only 100 Tablets

Each film-coated tablet contains
sertraline hydrochloride, USP
equivalent to 50 mg of sertraline.

Dispense in a tight, light-resistant
container as defined in the USP
using a child-resistant closure.

Keep container tightly closed.

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

Store at 20° to 25°C (68° to 77°F).
[See USP Controlled Room
Temperature.]

Usual Dosage: See accompanying
prescribing information.

Mylan Pharmaceuticals Inc.
Morgantown, WV 26505 U.S.A.

Mylan.com

RM8121A5

Sertraline Hydrochloride Tablets, USP 50 mg Bottle Label

PRINCIPAL DISPLAY PANEL

NDC 0378-8127-01

Sertraline
Hydrochloride
Tablets, USP
100 mg

PHARMACIST: Dispense the accompanying
Medication Guide to each patient.

Rx only 100 Tablets

Each film-coated tablet contains
sertraline hydrochloride, USP
equivalent to 100 mg of sertraline.

Dispense in a tight, light-resistant
container as defined in the USP
using a child-resistant closure.

Keep container tightly closed.

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

Store at 20° to 25°C (68° to 77°F).
[See USP Controlled Room
Temperature.]

Usual Dosage: See accompanying
prescribing information.

Mylan Pharmaceuticals Inc.
Morgantown, WV 26505 U.S.A.

Mylan.com

RM8127A5

Sertraline Hydrochloride Tablets, USP 100 mg Bottle Label