NDC Code(s) : 71093-129-01, 71093-129-03, 71093-129-05, 71093-130-01, 71093-130-03, 71093-130-05, 71093-131-01, 71093-131-03, 71093-131-05
Packager : ACI Healthcare USA, 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:71093-129
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)
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE(UNII: O7TSZ97GEP)
ANHYDROUS LACTOSE(UNII: 3SY5LH9PMK)
MAGNESIUM STEARATE(UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
Product Characteristics
Color WHITE (White to off-white) Score 2 pieces
Shape ROUND (biconvex) Size 7 mm
Flavor Imprint Code ET52
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:71093-129-0130 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product20/08/2018
2NDC:71093-129-0390 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product20/08/2018
3NDC:71093-129-05500 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product20/08/2018
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076881 02/06/2007
SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDE TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:71093-130
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)
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE(UNII: O7TSZ97GEP)
ANHYDROUS LACTOSE(UNII: 3SY5LH9PMK)
MAGNESIUM STEARATE(UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
Product Characteristics
Color WHITE (White to off-white) Score 2 pieces
Shape ROUND (biconvex) Size 9 mm
Flavor Imprint Code ET53
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:71093-130-0130 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product20/08/2018
2NDC:71093-130-0390 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product20/08/2018
3NDC:71093-130-05500 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product20/08/2018
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076881 02/06/2007
SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDE TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:71093-131
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)
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE(UNII: O7TSZ97GEP)
ANHYDROUS LACTOSE(UNII: 3SY5LH9PMK)
MAGNESIUM STEARATE(UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
Product Characteristics
Color WHITE (White to off-white) Score 2 pieces
Shape ROUND (biconvex) Size 11 mm
Flavor Imprint Code ET54
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:71093-131-0130 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product20/08/2018
2NDC:71093-131-0390 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product20/08/2018
3NDC:71093-131-05500 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product20/08/2018
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076881 02/06/2007

LABELER - ACI Healthcare USA, Inc.(080430318)

REGISTRANT - ACI HealthCare Limited(731584418)

Establishment
Name Address ID/FEI Business Operations
Elysium Pharmaceuticals Limited 863182240 MANUFACTURE(71093-129, 71093-130, 71093-131), analysis(71093-129, 71093-130, 71093-131), pack(71093-129, 71093-130, 71093-131)

Establishment
Name Address ID/FEI Business Operations
InvaTech Pharma Solutions LLC 078602180 pack(71093-129, 71093-130, 71093-131)

PRINCIPAL DISPLAY PANEL

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