SERTRALINE HYDROCHLORIDE (Page 11 of 11)

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SERTRALINE HYDROCHLORIDE sertraline hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55700-948(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:55700-948-30 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:55700-948-90 90 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202825 09/27/2021
Labeler — Quality Care Products, LLC (831276758)
Establishment
Name Address ID/FEI Operations
Quality Care Products, LLC 831276758 repack (55700-948)

Revised: 12/2021 Quality Care Products, LLC

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