NDC Code(s) : 70954-319-10
Packager : ANI Pharmaceuticals, Inc.

Category : Human Prescription Drug Label

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Paroxetine Paroxetine SUSPENSION
Product Information
Product Type Human Prescription Drug Label Item Code (Source) NDC:70954-319
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PAROXETINE HYDROCHLORIDE HEMIHYDRATE(UNII: X2ELS050D8)
(PAROXETINE - UNII:41VRH5220H) 		PAROXETINE10 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
POLACRILIN POTASSIUM(UNII: 0BZ5A00FQU)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
CARBOXYMETHYLCELLULOSE SODIUM(UNII: K679OBS311)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
GLYCERIN(UNII: PDC6A3C0OX)
SORBITOL(UNII: 506T60A25R)
METHYLPARABEN(UNII: A2I8C7HI9T)
PROPYLPARABEN(UNII: Z8IX2SC1OH)
TRISODIUM CITRATE DIHYDRATE(UNII: B22547B95K)
ANHYDROUS CITRIC ACID(UNII: XF417D3PSL)
SACCHARIN SODIUM MONOHYDRATE(UNII: A9CO00M9HV)
TRIACETIN(UNII: XHX3C3X673)
FD&C YELLOW NO. 6(UNII: H77VEI93A8)
DIMETHICONE(UNII: 92RU3N3Y1O)
WATER(UNII: 059QF0KO0R)
Product Characteristics
Color ORANGE Score
Shape Size
Flavor ORANGE Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:70954-319-10250 mL in 1 BOTTLE Type 0: Not a Combination Product09/03/2021
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA215003 09/03/2021

LABELER - ANI Pharmaceuticals, Inc.(145588013)

Establishment
Name Address ID/FEI Business Operations
Novitium Pharma LLC 080301870 ANALYSIS(70954-319), LABEL(70954-319), MANUFACTURE(70954-319), PACK(70954-319)

PRINCIPAL DISPLAY PANEL


paroxetine