Sertraline Hydrochloride (Page 11 of 11)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 25 mg

25 mg
(click image for full-size original)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 50 mg

50 mg
(click image for full-size original)



PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 100 mg

100 mg
(click image for full-size original)

SERTRALINE HYDROCHLORIDE sertraline hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:76420-779(NDC:65862-011)
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
MICROCRYSTALLINE CELLULOSE
SODIUM STARCH GLYCOLATE TYPE A POTATO
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
DIBASIC CALCIUM PHOSPHATE DIHYDRATE
MAGNESIUM STEARATE
HYPROMELLOSE 2910 (6 MPA.S)
TITANIUM DIOXIDE
POLYETHYLENE GLYCOL 400
POLYSORBATE 80
D&C YELLOW NO. 10
FD&C BLUE NO. 1
FD&C RED NO. 40
Product Characteristics
Color green Score 2 pieces
Shape CAPSULE (Biconvex) Size 7mm
Flavor Imprint Code A;1;6
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:76420-779-30 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:76420-779-60 60 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:76420-779-90 90 TABLET, FILM COATED in 1 BOTTLE None
4 NDC:76420-779-01 100 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077206 02/06/2007
SERTRALINE HYDROCHLORIDE sertraline hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:76420-781(NDC:65862-012)
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
MICROCRYSTALLINE CELLULOSE
SODIUM STARCH GLYCOLATE TYPE A POTATO
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
DIBASIC CALCIUM PHOSPHATE DIHYDRATE
MAGNESIUM STEARATE
HYPROMELLOSE 2910 (6 MPA.S)
TITANIUM DIOXIDE
POLYETHYLENE GLYCOL 400
POLYSORBATE 80
FD&C BLUE NO. 2
Product Characteristics
Color blue Score 2 pieces
Shape CAPSULE (Biconvex) Size 10mm
Flavor Imprint Code A;1;7
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:76420-781-30 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:76420-781-60 60 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:76420-781-90 90 TABLET, FILM COATED in 1 BOTTLE None
4 NDC:76420-781-01 100 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077206 02/06/2007
SERTRALINE HYDROCHLORIDE sertraline hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:76420-786(NDC:65862-013)
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
MICROCRYSTALLINE CELLULOSE
SODIUM STARCH GLYCOLATE TYPE A POTATO
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
DIBASIC CALCIUM PHOSPHATE DIHYDRATE
MAGNESIUM STEARATE
HYPROMELLOSE 2910 (6 MPA.S)
TITANIUM DIOXIDE
POLYETHYLENE GLYCOL 400
POLYSORBATE 80
FERRIC OXIDE YELLOW
Product Characteristics
Color yellow Score 2 pieces
Shape CAPSULE (Biconvex) Size 13mm
Flavor Imprint Code A;1;8
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:76420-786-30 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:76420-786-60 60 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:76420-786-90 90 TABLET, FILM COATED in 1 BOTTLE None
4 NDC:76420-786-01 100 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077206 02/06/2007
Labeler — Asclemed USA, Inc. (059888437)
Establishment
Name Address ID/FEI Operations
ASCLEMED USA INC. DBA ENOVACHEM 059888437 relabel (76420-779), relabel (76420-781), relabel (76420-786), repack (76420-779), repack (76420-781), repack (76420-786)

Revised: 03/2024 Asclemed USA, Inc.

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2024. All Rights Reserved.