Sertraline (Page 10 of 10)

Package/Label Display Panel

Sertraline Hydrochloride Tablets USP

25 mg*

100 Tablets

carton label
(click image for full-size original)

Package/Label Display Panel

Sertraline Hydrochloride Tablets USP

50 mg*

100 Tablets

carton label
(click image for full-size original)

Package/Label Display Panel

Sertraline Hydrochloride Tablets, USP

100 mg

100 Tablets

carton label
(click image for full-size original)
SERTRALINE sertraline tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0904-6924(NDC:68180-351)
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
ANHYDROUS DIBASIC CALCIUM PHOSPHATE
D&C YELLOW NO. 10
FD&C BLUE NO. 1
FD&C RED NO. 40
HYPROMELLOSE, UNSPECIFIED
SODIUM STARCH GLYCOLATE TYPE A POTATO
MICROCRYSTALLINE CELLULOSE
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL, UNSPECIFIED
POLYSORBATE 80
TITANIUM DIOXIDE
Product Characteristics
Color GREEN Score 2 pieces
Shape CAPSULE (capsule shaped biconvex) Size 7mm
Flavor Imprint Code L;U;D01
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0904-6924-61 100 BLISTER PACK in 1 CARTON contains a BLISTER PACK
1 1 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (0904-6924-61)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077670 02/06/2007
SERTRALINE sertraline tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0904-6925(NDC:68180-352)
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
ANHYDROUS DIBASIC CALCIUM PHOSPHATE
FD&C BLUE NO. 2
HYPROMELLOSE, UNSPECIFIED
SODIUM STARCH GLYCOLATE TYPE A POTATO
MICROCRYSTALLINE CELLULOSE
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL, UNSPECIFIED
POLYSORBATE 80
TITANIUM DIOXIDE
Product Characteristics
Color BLUE Score 2 pieces
Shape CAPSULE (capsule shaped, biconvex) Size 10mm
Flavor Imprint Code L;U;D02
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0904-6925-61 100 BLISTER PACK in 1 CARTON contains a BLISTER PACK
1 1 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (0904-6925-61)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077670 02/06/2007
SERTRALINE sertraline tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0904-6926(NDC:68180-353)
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
ANHYDROUS DIBASIC CALCIUM PHOSPHATE
FERRIC OXIDE YELLOW
HYPROMELLOSE, UNSPECIFIED
SODIUM STARCH GLYCOLATE TYPE A POTATO
MICROCRYSTALLINE CELLULOSE
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL, UNSPECIFIED
POLYSORBATE 80
TITANIUM DIOXIDE
Product Characteristics
Color YELLOW Score 2 pieces
Shape CAPSULE (capsule shaped, biconvex) Size 13mm
Flavor Imprint Code L;U;D03
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0904-6926-61 100 BLISTER PACK in 1 CARTON contains a BLISTER PACK
1 1 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (0904-6926-61)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077670 02/06/2007
Labeler — Major Pharmaceuticals (191427277)

Revised: 11/2020 Major Pharmaceuticals

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