Sertraline Hydrochloride: Package Insert and Label Information (Page 7 of 7)

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NDC: 51655-173-52

Label
(click image for full-size original)
SERTRALINE HYDROCHLORIDE sertraline hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51655-173(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:51655-173-26 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
2 NDC:51655-173-52 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077206 06/17/2020
Labeler — Northwind Pharmaceuticals (036986393)
Registrant — Northwind Pharmaceuticals (036986393)
Establishment
Name Address ID/FEI Operations
Northwind Pharmaceuticals 036986393 repack (51655-173)

Revised: 01/2022 Northwind Pharmaceuticals

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