NDC Code(s) : 70010-203-03, 70010-203-09, 70010-203-05, 70010-203-10, 70010-204-03, 70010-204-09, 70010-204-05, 70010-204-10, 70010-205-03, 70010-205-09, 70010-205-05, 70010-205-10
Packager : Granules Pharmaceuticals Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Sertraline hydrochlorideSertraline hydrochloride TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70010-203
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)
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS(UNII: L11K75P92J)
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED(UNII: 2165RE0K14)
MAGNESIUM STEARATE(UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
SODIUM STARCH GLYCOLATE TYPE A(UNII: H8AV0SQX4D)
TALC(UNII: 7SEV7J4R1U)
HYPROMELLOSE 2910 (5 MPA.S)(UNII: R75537T0T4)
POLYETHYLENE GLYCOL 400(UNII: B697894SGQ)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
D&C YELLOW NO. 10(UNII: 35SW5USQ3G)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
FD&C BLUE NO. 2(UNII: L06K8R7DQK)
Product Characteristics
Color green Score 2 pieces
Shape CAPSULE Size 8 mm
Flavor Imprint Code G;74
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:70010-203-0330 in 1 BOTTLE Type 0: Not a Combination Product15/05/2023
2NDC:70010-203-0990 in 1 BOTTLE Type 0: Not a Combination Product15/05/2023
3NDC:70010-203-05500 in 1 BOTTLE Type 0: Not a Combination Product15/05/2023
4NDC:70010-203-101000 in 1 BOTTLE Type 0: Not a Combination Product15/05/2023
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078403 05/15/2023
Sertraline hydrochlorideSertraline hydrochloride TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70010-204
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)
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS(UNII: L11K75P92J)
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED(UNII: 2165RE0K14)
MAGNESIUM STEARATE(UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
SODIUM STARCH GLYCOLATE TYPE A(UNII: H8AV0SQX4D)
TALC(UNII: 7SEV7J4R1U)
HYPROMELLOSE 2910 (5 MPA.S)(UNII: R75537T0T4)
POLYETHYLENE GLYCOL 400(UNII: B697894SGQ)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
FD&C BLUE NO. 2(UNII: L06K8R7DQK)
Product Characteristics
Color blue Score 2 pieces
Shape CAPSULE Size 10 mm
Flavor Imprint Code G;75
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:70010-204-0330 in 1 BOTTLE Type 0: Not a Combination Product15/05/2023
2NDC:70010-204-0990 in 1 BOTTLE Type 0: Not a Combination Product15/05/2023
3NDC:70010-204-05500 in 1 BOTTLE Type 0: Not a Combination Product15/05/2023
4NDC:70010-204-101000 in 1 BOTTLE Type 0: Not a Combination Product15/05/2023
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078403 05/15/2023
Sertraline hydrochlorideSertraline hydrochloride TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70010-205
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)
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS(UNII: L11K75P92J)
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED(UNII: 2165RE0K14)
MAGNESIUM STEARATE(UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
SODIUM STARCH GLYCOLATE TYPE A(UNII: H8AV0SQX4D)
TALC(UNII: 7SEV7J4R1U)
HYPROMELLOSE 2910 (5 MPA.S)(UNII: R75537T0T4)
POLYETHYLENE GLYCOL 400(UNII: B697894SGQ)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
D&C YELLOW NO. 10(UNII: 35SW5USQ3G)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
Product Characteristics
Color yellow Score 2 pieces
Shape CAPSULE Size 12 mm
Flavor Imprint Code G;76
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:70010-205-0330 in 1 BOTTLE Type 0: Not a Combination Product15/05/2023
2NDC:70010-205-0990 in 1 BOTTLE Type 0: Not a Combination Product15/05/2023
3NDC:70010-205-05500 in 1 BOTTLE Type 0: Not a Combination Product15/05/2023
4NDC:70010-205-101000 in 1 BOTTLE Type 0: Not a Combination Product15/05/2023
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078403 05/15/2023

LABELER - Granules Pharmaceuticals Inc.(079825711)

Establishment
Name Address ID/FEI Business Operations
Granules India Limited 918609236 analysis(70010-203, 70010-204, 70010-205), label(70010-203, 70010-204, 70010-205), manufacture(70010-203, 70010-204, 70010-205), pack(70010-203, 70010-204, 70010-205)

PRINCIPAL DISPLAY PANEL

70010-203-1070010-203-1070010-203-10