Paroxetine (Page 18 of 18)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC; 51655-356-25

Label
(click image for full-size original)
PAROXETINE paroxetine tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51655-356(NDC:68382-098)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PAROXETINE HYDROCHLORIDE HEMIHYDRATE (PAROXETINE) PAROXETINE 20 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS DIBASIC CALCIUM PHOSPHATE
ANHYDROUS LACTOSE
HYPROMELLOSES
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL 6000
SODIUM STARCH GLYCOLATE TYPE A POTATO
POVIDONE
TALC
TITANIUM DIOXIDE
Product Characteristics
Color white (WHITE TO OFF-WHITE) Score 2 pieces
Shape ROUND (ROUND) Size 8mm
Flavor Imprint Code ZC;16
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51655-356-25 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077584 05/28/2020
Labeler — Northwind Pharmaceuticals (036986393)
Registrant — Northwind Pharmaceuticals (036986393)
Establishment
Name Address ID/FEI Operations
Northwind Pharmaceuticals 036986393 repack (51655-356)

Revised: 12/2021 Northwind Pharmaceuticals

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