Sertraline (Page 9 of 9)

SERTRALINE

Label ImageLabel Image
SERTRALINE sertraline tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50090-5848(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:50090-5848-0 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:50090-5848-1 90 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077670 02/06/2007
Labeler — A-S Medication Solutions (830016429)
Establishment
Name Address ID/FEI Operations
A-S Medication Solutions 830016429 RELABEL (50090-5848), REPACK (50090-5848)

Revised: 11/2021 A-S Medication Solutions

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