NDC Code(s) : 23155-757-03, 23155-757-09, 23155-757-05, 23155-758-03, 23155-758-09, 23155-758-05, 23155-758-69, 23155-759-03, 23155-759-09, 23155-759-05
Packager : Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

SertralineSertraline TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:23155-757
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
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
DIBASIC CALCIUM PHOSPHATE DIHYDRATE(UNII: O7TSZ97GEP)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
POVIDONE(UNII: FZ989GH94E)
D&C YELLOW NO. 10 ALUMINUM LAKE(UNII: CQ3XH3DET6)
FD&C BLUE NO. 2 ALUMINUM LAKE(UNII: 4AQJ3LG584)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Product Characteristics
Color GREEN (light green) Score 2 pieces
Shape OVAL (elliptical shaped bisect) Size 9 mm
Flavor Imprint Code 757
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:23155-757-0330 in 1 BOTTLE Type 0: Not a Combination Product23/02/2023
2NDC:23155-757-0990 in 1 BOTTLE Type 0: Not a Combination Product23/02/2023
3NDC:23155-757-05500 in 1 BOTTLE Type 0: Not a Combination Product23/02/2023
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076465 02/23/2023
SertralineSertraline TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:23155-758
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
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
DIBASIC CALCIUM PHOSPHATE DIHYDRATE(UNII: O7TSZ97GEP)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
POVIDONE, UNSPECIFIED(UNII: FZ989GH94E)
FD&C BLUE NO. 2 ALUMINUM LAKE(UNII: 4AQJ3LG584)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Product Characteristics
Color BLUE (light-blue) Score 2 pieces
Shape OVAL (elliptical shaped tablet) Size 11 mm
Flavor Imprint Code 758
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:23155-758-0330 in 1 BOTTLE Type 0: Not a Combination Product23/02/2023
2NDC:23155-758-0990 in 1 BOTTLE Type 0: Not a Combination Product23/02/2023
3NDC:23155-758-05500 in 1 BOTTLE Type 0: Not a Combination Product23/02/2023
4NDC:23155-758-695000 in 1 BOTTLE Type 0: Not a Combination Product23/02/2023
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076465 02/23/2023
SertralineSertraline TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:23155-759
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
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
DIBASIC CALCIUM PHOSPHATE DIHYDRATE(UNII: O7TSZ97GEP)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
POVIDONE, UNSPECIFIED(UNII: FZ989GH94E)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
Product Characteristics
Color YELLOW (light yellow) Score 2 pieces
Shape OVAL (elliptical shaped tablet) Size 14 mm
Flavor Imprint Code 759
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:23155-759-0330 in 1 BOTTLE Type 0: Not a Combination Product23/02/2023
2NDC:23155-759-0990 in 1 BOTTLE Type 0: Not a Combination Product23/02/2023
3NDC:23155-759-05500 in 1 BOTTLE Type 0: Not a Combination Product23/03/2023
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076465 02/23/2023

LABELER - Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.(780779901)

REGISTRANT - Heritage Pharma Labs Inc. d/b/a Avet Pharmaceuticals Labs Inc.(189630168)

Establishment
Name Address ID/FEI Business Operations
Sidmak Laboratories (India) Pvt.Ltd 677604490 manufacture(23155-757, 23155-758, 23155-759)

PRINCIPAL DISPLAY PANEL

NDC 23155-757-03
Sertraline Hydrochloride Tablets, USP
25 mg
PHARMACIST: PLEASE DISPENSE WITH
MEDICATION GUIDE
30 Tablets
Rx only

Container Label 25 mg- 30 Tablets

NDC 23155-758-03
Sertraline Hydrochloride Tablets, USP
50 mg
PHARMACIST: PLEASE DISPENSE WITH
MEDICATION GUIDE
30 Tablets
Rx only

Container Label 25 mg- 30 Tablets

NDC 23155-759-03
Sertraline Hydrochloride Tablets, USP
100 mg
PHARMACIST: PLEASE DISPENSE WITH MEDICATION GUIDE
30 Tablets
Rx only

Container Label 25 mg- 30 Tablets