Sertraline Hydrochloride (Page 10 of 10)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

70010-203-10
(click image for full-size original)
70010-204-10
(click image for full-size original)
70010-205-10
(click image for full-size original)

SERTRALINE HYDROCHLORIDE sertraline 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 (SERTRALINE) SERTRALINE 25 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
SODIUM STARCH GLYCOLATE TYPE A
TALC
HYPROMELLOSE 2910 (5 MPA.S)
POLYETHYLENE GLYCOL 400
TITANIUM DIOXIDE
D&C YELLOW NO. 10
FERROSOFERRIC OXIDE
FD&C BLUE NO. 2
Product Characteristics
Color green Score 2 pieces
Shape CAPSULE Size 8mm
Flavor Imprint Code G;74
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70010-203-03 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:70010-203-09 90 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:70010-203-05 500 TABLET, FILM COATED in 1 BOTTLE None
4 NDC:70010-203-10 1000 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078403 05/15/2023
SERTRALINE HYDROCHLORIDE sertraline 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 (SERTRALINE) SERTRALINE 50 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
SODIUM STARCH GLYCOLATE TYPE A
TALC
HYPROMELLOSE 2910 (5 MPA.S)
POLYETHYLENE GLYCOL 400
TITANIUM DIOXIDE
FD&C BLUE NO. 1
FD&C BLUE NO. 2
Product Characteristics
Color blue Score 2 pieces
Shape CAPSULE Size 10mm
Flavor Imprint Code G;75
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70010-204-03 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:70010-204-09 90 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:70010-204-05 500 TABLET, FILM COATED in 1 BOTTLE None
4 NDC:70010-204-10 1000 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078403 05/15/2023
SERTRALINE HYDROCHLORIDE sertraline 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 (SERTRALINE) SERTRALINE 100 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
SODIUM STARCH GLYCOLATE TYPE A
TALC
HYPROMELLOSE 2910 (5 MPA.S)
POLYETHYLENE GLYCOL 400
TITANIUM DIOXIDE
D&C YELLOW NO. 10
FERRIC OXIDE YELLOW
Product Characteristics
Color yellow Score 2 pieces
Shape CAPSULE Size 12mm
Flavor Imprint Code G;76
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70010-205-03 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:70010-205-09 90 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:70010-205-05 500 TABLET, FILM COATED in 1 BOTTLE None
4 NDC:70010-205-10 1000 TABLET, FILM COATED in 1 BOTTLE None
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 Operations
Granules India Limited 918609236 analysis (70010-203), analysis (70010-204), analysis (70010-205), label (70010-203), label (70010-204), label (70010-205), manufacture (70010-203), manufacture (70010-204), manufacture (70010-205), pack (70010-203), pack (70010-204), pack (70010-205)

Revised: 04/2023 Granules Pharmaceuticals Inc.

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