NDC Code(s) : 43602-979-15, 43602-979-16, 43602-980-15, 43602-980-16, 43602-981-15, 43602-981-16
Packager : Ascent Pharmaceuticals, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

SERTRALINE HYDROCHLORIDEsertraline hydrochloride TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43602-979
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
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
HYDROXYPROPYL CELLULOSE, UNSPECIFIED(UNII: 9XZ8H6N6OH)
SODIUM STARCH GLYCOLATE TYPE A POTATO(UNII: 5856J3G2A2)
MAGNESIUM STEARATE(UNII: 70097M6I30)
HYPROMELLOSES(UNII: 3NXW29V3WO)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
POLYETHYLENE GLYCOL 400(UNII: B697894SGQ)
FD&C BLUE NO. 2(UNII: L06K8R7DQK)
D&C YELLOW NO. 10 ALUMINUM LAKE(UNII: CQ3XH3DET6)
Product Characteristics
Color green Score 2
Shape CAPSULE Size 8 mm
Flavor Imprint Code T;25
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:43602-979-1530 in 1 BOTTLE Type 0: Not a Combination Product05/03/2021
2NDC:43602-979-16500 in 1 BOTTLE Type 0: Not a Combination Product05/03/2021
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA214790 05/03/2021
SERTRALINE HYDROCHLORIDEsertraline hydrochloride TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43602-980
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
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
HYDROXYPROPYL CELLULOSE, UNSPECIFIED(UNII: 9XZ8H6N6OH)
SODIUM STARCH GLYCOLATE TYPE A POTATO(UNII: 5856J3G2A2)
MAGNESIUM STEARATE(UNII: 70097M6I30)
HYPROMELLOSES(UNII: 3NXW29V3WO)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
FD&C BLUE NO. 2(UNII: L06K8R7DQK)
POLYETHYLENE GLYCOL 400(UNII: B697894SGQ)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Product Characteristics
Color blue Score 2
Shape CAPSULE Size 10 mm
Flavor Imprint Code T;50
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:43602-980-1530 in 1 BOTTLE Type 0: Not a Combination Product05/03/2021
2NDC:43602-980-16500 in 1 BOTTLE Type 0: Not a Combination Product05/03/2021
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA214790 05/03/2021
SERTRALINE HYDROCHLORIDEsertraline hydrochloride TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43602-981
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
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
HYDROXYPROPYL CELLULOSE, UNSPECIFIED(UNII: 9XZ8H6N6OH)
SODIUM STARCH GLYCOLATE TYPE A POTATO(UNII: 5856J3G2A2)
MAGNESIUM STEARATE(UNII: 70097M6I30)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
HYPROMELLOSES(UNII: 3NXW29V3WO)
POLYETHYLENE GLYCOL 400(UNII: B697894SGQ)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
FERRIC OXIDE RED(UNII: 1K09F3G675)
Product Characteristics
Color yellow Score 2
Shape capsule Size 13 mm
Flavor Imprint Code T;100
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:43602-981-1530 in 1 BOTTLE Type 0: Not a Combination Product05/03/2021
2NDC:43602-981-16500 in 1 BOTTLE Type 0: Not a Combination Product05/03/2021
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA214790 05/03/2021

LABELER - Ascent Pharmaceuticals, Inc.(080938961)

Establishment
Name Address ID/FEI Business Operations
Ascent Pharmaceuticals, Inc. 080938961 analysis(43602-979, 43602-980, 43602-981), manufacture(43602-979, 43602-980, 43602-981), pack(43602-979, 43602-980, 43602-981)

PRINCIPAL DISPLAY PANEL

Sertraline HCl Tablets-25 mg

Sertraline HCl Tablets-25 mg

Sertraline HCl Tablets-25 mg