SERTRALINE HYDROCHLORIDE (Page 12 of 12)

PRINCIPAL DISPLAY PANEL — Sertraline Hydrochloride Tablets USP 25 mg — 30 Tablets Label

NDC 16729- 215 -10
Sertraline Hydrochloride Tablets USP
25 mg *
Rx Only
Pharmacist: Please Dispense With
Medication Guide Provided Separately
30 Tablets

PRINCIPAL DISPLAY PANEL -- Sertraline Hydrochloride Tablets USP 25 mg -- 30 Tablets Label
(click image for full-size original)

NDC 16729- 215 -43
UNIT DOSE
Sertraline Hydrochloride Tablets USP
25 mg *
For in-institution use only
Rx Only
Pharmacist: Please Dispense With Medication Guide Provided Separately. 100 Tablets (10 x 10 unit-dose)

Sample Blister
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — Sertraline Hydrochloride Tablets USP 50 mg — 30 Tablets Label

NDC 16729- 216 -10
Sertraline Hydrochloride Tablets USP
50 mg *
Rx Only
Pharmacist: Please Dispense With
Medication Guide Provided Separately.
30 Tablets

PRINCIPAL DISPLAY PANEL -- Sertraline Hydrochloride Tablets USP 50 mg -- 30 Tablets Label
(click image for full-size original)

NDC 16729- 216 -43
Sertraline Hydrochloride Tablets USP
50 mg *
For in-institution use only
Rx Only
Pharmacist: Please Dispense With Medication Guide Provided Separately. 100 Tablets (10 x 10 unit-dose)

Package
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — Sertraline Hydrochloride Tablets USP 100 mg — 30 Tablets Label

NDC 16729- 217 -10
Sertraline Hydrochloride Tablets USP
100 mg *
Rx Only
Pharmacist: Please Dispense With
Medication Guide Provided Separately.
30 Tablets

PRINCIPAL DISPLAY PANEL -- Sertraline Hydrochloride Tablets USP 100 mg -- 30 Tablets Label
(click image for full-size original)

NDC 16729- 217 -43
UNIT DOSE
Sertraline Hydrochloride Tablets USP
100 mg *
For in-institution use only
Rx Only
Pharmacist: Please Dispense With Medication Guide Provided Separately. 100 Tablets (10 x 10 unit-dose)

Package
(click image for full-size original)
SERTRALINE HYDROCHLORIDE sertraline hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:16729-215
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
CELLULOSE, MICROCRYSTALLINE
SODIUM STARCH GLYCOLATE TYPE A POTATO
ANHYDROUS DIBASIC CALCIUM PHOSPHATE
MAGNESIUM STEARATE
HYPROMELLOSE 2910 (5 MPA.S)
POLYETHYLENE GLYCOL 400
TITANIUM DIOXIDE
POLYSORBATE 80
D&C YELLOW NO. 10
FD&C BLUE NO. 1
HYDROXYPROPYL CELLULOSE (TYPE L)
Product Characteristics
Color green (light green) Score 2 pieces
Shape ROUND (Biconvex) Size 6mm
Flavor Imprint Code S1
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:16729-215-10 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:16729-215-11 50 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:16729-215-15 90 TABLET, FILM COATED in 1 BOTTLE None
4 NDC:16729-215-16 500 TABLET, FILM COATED in 1 BOTTLE None
5 NDC:16729-215-43 100 TABLET, FILM COATED in 1 BOX, UNIT-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202825 02/09/2017
SERTRALINE HYDROCHLORIDE sertraline hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:16729-216
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
CELLULOSE, MICROCRYSTALLINE
SODIUM STARCH GLYCOLATE TYPE A POTATO
HYDROXYPROPYL CELLULOSE (TYPE L)
ANHYDROUS DIBASIC CALCIUM PHOSPHATE
MAGNESIUM STEARATE
HYPROMELLOSE 2910 (5 MPA.S)
POLYETHYLENE GLYCOL 400
POLYSORBATE 80
TITANIUM DIOXIDE
FD&C BLUE NO. 2
Product Characteristics
Color blue (light blue) Score 2 pieces
Shape ROUND (Biconvex) Size 7mm
Flavor Imprint Code S2
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:16729-216-10 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:16729-216-15 90 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:16729-216-01 100 TABLET, FILM COATED in 1 BOTTLE None
4 NDC:16729-216-16 500 TABLET, FILM COATED in 1 BOTTLE None
5 NDC:16729-216-43 100 TABLET, FILM COATED in 1 BOX, UNIT-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202825 02/09/2017
SERTRALINE HYDROCHLORIDE sertraline hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:16729-217
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
CELLULOSE, MICROCRYSTALLINE
SODIUM STARCH GLYCOLATE TYPE A POTATO
HYDROXYPROPYL CELLULOSE (TYPE L)
ANHYDROUS DIBASIC CALCIUM PHOSPHATE
MAGNESIUM STEARATE
HYPROMELLOSE 2910 (5 MPA.S)
POLYETHYLENE GLYCOL 400
TITANIUM DIOXIDE
POLYSORBATE 80
FERRIC OXIDE YELLOW
Product Characteristics
Color yellow Score 2 pieces
Shape ROUND (Biconvex) Size 9mm
Flavor Imprint Code S3
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:16729-217-10 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:16729-217-15 90 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:16729-217-01 100 TABLET, FILM COATED in 1 BOTTLE None
4 NDC:16729-217-16 500 TABLET, FILM COATED in 1 BOTTLE None
5 NDC:16729-217-43 100 TABLET, FILM COATED in 1 BOX, UNIT-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202825 02/09/2017
Labeler — Accord Healthcare, Inc. (604222237)
Establishment
Name Address ID/FEI Operations
Intas Pharmaceuticals Ltd 725927649 manufacture (16729-215), manufacture (16729-216), manufacture (16729-217), analysis (16729-215), analysis (16729-216), analysis (16729-217)
Establishment
Name Address ID/FEI Operations
Intas Pharmaceuticals Ltd 915837971 manufacture (16729-215), analysis (16729-215), manufacture (16729-216), analysis (16729-216), manufacture (16729-217), analysis (16729-217)

Revised: 09/2021 Accord Healthcare, Inc.

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