NDC Code(s) : 68645-498-01, 68645-499-01, 68645-500-01
Packager : Legacy Pharmaceutical Packaging, LLC

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:68645-498(NDC:31722-212)
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
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE(UNII: O7TSZ97GEP)
HYDROXYPROPYL CELLULOSE (TYPE H)(UNII: RFW2ET671P)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
MAGNESIUM STEARATE(UNII: 70097M6I30)
SODIUM STARCH GLYCOLATE TYPE A POTATO(UNII: 5856J3G2A2)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
HYPROMELLOSE 2910 (3 MPA.S)(UNII: 0VUT3PMY82)
HYPROMELLOSE 2910 (6 MPA.S)(UNII: 0WZ8WG20P6)
POLYETHYLENE GLYCOL 400(UNII: B697894SGQ)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
D&C YELLOW NO. 10(UNII: 35SW5USQ3G)
FD&C BLUE NO. 2(UNII: L06K8R7DQK)
Product Characteristics
Color GREEN (Light Green) Score no score
Shape OVAL (modified, biconvex) Size 8 mm
Flavor Imprint Code 212;IG
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:68645-498-01100 in 1 BOTTLE Type 0: Not a Combination Product18/10/2007
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077397 10/18/2007 11/30/2017
Sertraline HydrochlorideSertraline Hydrochloride TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68645-499(NDC:31722-213)
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
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE(UNII: O7TSZ97GEP)
HYDROXYPROPYL CELLULOSE (TYPE H)(UNII: RFW2ET671P)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
MAGNESIUM STEARATE(UNII: 70097M6I30)
SODIUM STARCH GLYCOLATE TYPE A POTATO(UNII: 5856J3G2A2)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
HYPROMELLOSE 2910 (3 MPA.S)(UNII: 0VUT3PMY82)
HYPROMELLOSE 2910 (6 MPA.S)(UNII: 0WZ8WG20P6)
POLYETHYLENE GLYCOL 400(UNII: B697894SGQ)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
FD&C BLUE NO. 2(UNII: L06K8R7DQK)
Product Characteristics
Color BLUE (Light Blue) Score no score
Shape OVAL (modified, biconvex) Size 10 mm
Flavor Imprint Code 213;IG
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:68645-499-01100 in 1 BOTTLE Type 0: Not a Combination Product18/10/2007
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077397 10/18/2007 05/31/2018
Sertraline HydrochlorideSertraline Hydrochloride TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68645-500(NDC:31722-214)
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
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE(UNII: O7TSZ97GEP)
HYDROXYPROPYL CELLULOSE (TYPE H)(UNII: RFW2ET671P)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
MAGNESIUM STEARATE(UNII: 70097M6I30)
SODIUM STARCH GLYCOLATE TYPE A POTATO(UNII: 5856J3G2A2)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
HYPROMELLOSE 2910 (3 MPA.S)(UNII: 0VUT3PMY82)
HYPROMELLOSE 2910 (6 MPA.S)(UNII: 0WZ8WG20P6)
POLYETHYLENE GLYCOL 400(UNII: B697894SGQ)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
FERRIC OXIDE RED(UNII: 1K09F3G675)
Product Characteristics
Color YELLOW (Light Yellow) Score no score
Shape OVAL (modified, biconvex) Size 13 mm
Flavor Imprint Code 214;IG
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:68645-500-01100 in 1 BOTTLE Type 0: Not a Combination Product18/10/2007
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077397 10/18/2007 07/31/2018

PRINCIPAL DISPLAY PANEL

Sertraline Tablets, USP 25mg

PRINCIPAL DISPLAY PANEL

Sertraline Tablets, USP 50mg 

PRINCIPAL DISPLAY PANEL

Sertraline Tablets, USP 100mg