Sertraline Hydrochloride (Page 12 of 12)

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Sertraline 25mg tablet 30 count blister card
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Package/Label Display Panel

Sertraline 50mg Tablets 30 count blister card
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Package/Label Display Panel

Sertraline 100mg tablet 30 count blister card
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SERTRALINE HYDROCHLORIDE sertraline hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:58118-0833(NDC:69097-833)
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
DIBASIC CALCIUM PHOSPHATE DIHYDRATE
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
MICROCRYSTALLINE CELLULOSE
MAGNESIUM STEARATE
SODIUM STARCH GLYCOLATE TYPE A POTATO
TITANIUM DIOXIDE
HYPROMELLOSE 2910 (3 MPA.S)
HYPROMELLOSE 2910 (6 MPA.S)
POLYETHYLENE GLYCOL 400
POLYSORBATE 80
D&C YELLOW NO. 10
FD&C BLUE NO. 2
Product Characteristics
Color green (Light Green) Score 2 pieces
Shape OVAL (modified, biconvex) Size 8mm
Flavor Imprint Code 212;IG
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:58118-0833-8 30 TABLET in 1 BLISTER PACK None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077397 07/21/2016 12/01/2018
SERTRALINE HYDROCHLORIDE sertraline hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:58118-0834(NDC:69097-834)
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
DIBASIC CALCIUM PHOSPHATE DIHYDRATE
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
MICROCRYSTALLINE CELLULOSE
MAGNESIUM STEARATE
SODIUM STARCH GLYCOLATE TYPE A POTATO
TITANIUM DIOXIDE
HYPROMELLOSE 2910 (3 MPA.S)
HYPROMELLOSE 2910 (6 MPA.S)
POLYETHYLENE GLYCOL 400
POLYSORBATE 80
D&C YELLOW NO. 10
FD&C BLUE NO. 2
Product Characteristics
Color blue (Light Blue) Score 2 pieces
Shape OVAL (modified, biconvex) Size 10mm
Flavor Imprint Code 213;IG
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:58118-0834-8 30 TABLET in 1 BLISTER PACK None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077397 07/21/2016
SERTRALINE HYDROCHLORIDE sertraline hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:58118-0835(NDC:69097-835)
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
HYPROMELLOSE 2910 (3 MPA.S)
HYPROMELLOSE 2910 (6 MPA.S)
POLYETHYLENE GLYCOL 400
POLYSORBATE 80
D&C YELLOW NO. 10
FD&C BLUE NO. 2
DIBASIC CALCIUM PHOSPHATE DIHYDRATE
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
MICROCRYSTALLINE CELLULOSE
MAGNESIUM STEARATE
SODIUM STARCH GLYCOLATE TYPE A POTATO
TITANIUM DIOXIDE
Product Characteristics
Color yellow (Light Yellow) Score 2 pieces
Shape OVAL (modified, biconvex) Size 13mm
Flavor Imprint Code 214;IG
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:58118-0835-8 30 TABLET in 1 BLISTER PACK None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077397 07/21/2016 12/01/2018
Labeler — Clinical Solutions Wholesale, LLC (078710347)
Registrant — Clinical Solutions Wholesale, LLC (078710347)
Establishment
Name Address ID/FEI Operations
Clinical Solutions Wholesale, LLC 078710347 repack (58118-0833), repack (58118-0834), repack (58118-0835)

Revised: 09/2020 Clinical Solutions Wholesale, LLC

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