Naproxen Sodium (Page 9 of 9)

PRINCIPAL DISPLAY PANEL

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NAPROXEN SODIUM
naproxen sodium tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:53746-193
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NAPROXEN SODIUM (NAPROXEN) NAPROXEN SODIUM 275 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM
MAGNESIUM STEARATE
POLYVINYL ALCOHOL, UNSPECIFIED
POVIDONE
TALC
TITANIUM DIOXIDE
FD&C BLUE NO. 2
POLYETHYLENE GLYCOL, UNSPECIFIED
Product Characteristics
Color blue Score 2 pieces
Shape OVAL Size 12mm
Flavor Imprint Code IP;193
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:53746-193-01 100 TABLET in 1 BOTTLE None
2 NDC:53746-193-05 500 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078432 04/26/2007
NAPROXEN SODIUM
naproxen sodium tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:53746-194
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NAPROXEN SODIUM (NAPROXEN) NAPROXEN SODIUM 550 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM
MAGNESIUM STEARATE
POLYVINYL ALCOHOL, UNSPECIFIED
POVIDONE
TALC
TITANIUM DIOXIDE
FD&C BLUE NO. 2
POLYETHYLENE GLYCOL, UNSPECIFIED
Product Characteristics
Color blue Score 2 pieces
Shape OVAL Size 12mm
Flavor Imprint Code IP;194
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:53746-194-01 100 TABLET in 1 BOTTLE None
2 NDC:53746-194-05 500 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078432 04/26/2007
Labeler — Amneal Pharmaceuticals of New York LLC (123797875)
Establishment
Name Address ID/FEI Operations
Amneal Pharmaceuticals of New York, LLC 831227801 analysis (53746-193), analysis (53746-194), label (53746-193), label (53746-194), manufacture (53746-193), manufacture (53746-194), pack (53746-193), pack (53746-194)

Revised: 12/2021 Amneal Pharmaceuticals of New York LLC

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