Sertraline Hydrochloride: Package Insert and Label Information (Page 8 of 8)

Package/Label Display Panel

Sertraline 25mg tablet 30 count blister card
(click image for full-size original)

Package/Label Display Panel

Sertraline 50mg Tablets 30 count blister card
(click image for full-size original)

Package/Label Display Panel

Sertraline 100mg tablet 30 count blister card
(click image for full-size original)
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

DrugInserts.com provides trustworthy package insert and label information about marketed drugs as submitted by manufacturers to the US Food and Drug Administration. Package information is not reviewed or updated separately by DrugInserts.com. Every individual package label entry contains a unique identifier which can be used to secure further details directly from the US National Institutes of Health and/or the FDA.

https://druginserts.com/lib/rx/meds/sertraline-hydrochloride-38/page/8/

Clinical Trials

DrugInserts.com

Information Sections

RSS Feeds

About

As the leading independent provider of trustworthy medication information, we source our database directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. Our material is not intended as a substitute for direct consultation with a qualified health professional.

Terms of Use | Copyright © 2023. All Rights Reserved.