Naproxen tablet

Ingredients and appearance - Product information

Naproxen tablet- Naproxen

Product information

Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC: 68788-9906
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Naproxen ( UNII: 57Y76R9ATQ)( Naproxen - UNII: 57Y76R9ATQ ) 375 mgin 1

Inactive Ingredients

Ingredient Name Code
Croscarmellose sodium ( UNII: M28OL1HH48)
Povidones ( UNII: FZ989GH94E)
Magnesium stearate ( UNII: 70097M6I30)

Product Characteristics

Color WHITE Size 14 mm
Shape CAPSULE Score 1
Imprint Code IP189;375

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
ANDA ANDA075927 USA

Naproxen tablet- Naproxen

Product information

Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC: 68788-9907
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Naproxen ( UNII: 57Y76R9ATQ)( Naproxen - UNII: 57Y76R9ATQ ) 500 mgin 1

Inactive Ingredients

Ingredient Name Code
Croscarmellose sodium ( UNII: M28OL1HH48)
Povidones ( UNII: FZ989GH94E)
Magnesium stearate ( UNII: 70097M6I30)

Product Characteristics

Color WHITE Size 16 mm
Shape CAPSULE Score 1
Imprint Code IP190;500

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
ANDA ANDA075927 USA

Labeler - Preferred Pharmaceuticals, Inc.( 791119022)

Establishment

Name ID/FEI Business Operations
Preferred Pharmaceuticals, Inc. 791119022 REPACK( 68788-9906, 68788-9907)