Naproxen (Page 9 of 9)

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

NDC 68462–189-01

NAPROXEN TABLETS USP

375 mg – 100 Tablets

label375mg
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PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

NDC 68462–190-01

NAPROXEN TABLETS USP

500 mg – 100 Tablets

label500mg
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PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

NDC 68462–178-01

NAPROXEN SODIUM TABLETS USP

275 mg – 100 Tablets

label275mg
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PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

NDC 68462–179-01

NAPROXEN SODIUM TABLETS USP

550 mg – 100 Tablets

label550mg
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NAPROXEN naproxen tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68462-188
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NAPROXEN (NAPROXEN) NAPROXEN 250 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM
POVIDONE, UNSPECIFIED
MAGNESIUM STEARATE
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
MICROCRYSTALLINE CELLULOSE
Product Characteristics
Color ORANGE (Light orange) Score 2 pieces
Shape ROUND (Flat) Size 10mm
Flavor Imprint Code G;32;250
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68462-188-01 100 TABLET in 1 BOTTLE None
2 NDC:68462-188-05 500 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078250 07/01/2007
NAPROXEN naproxen tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68462-189
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NAPROXEN (NAPROXEN) NAPROXEN 375 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM
POVIDONE, UNSPECIFIED
MAGNESIUM STEARATE
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
MICROCRYSTALLINE CELLULOSE
Product Characteristics
Color ORANGE (Light orange) Score no score
Shape OVAL (Bi-Convex) Size 14mm
Flavor Imprint Code G;32;375
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68462-189-01 100 TABLET in 1 BOTTLE None
2 NDC:68462-189-05 500 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078250 07/01/2007
NAPROXEN naproxen tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68462-190
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NAPROXEN (NAPROXEN) NAPROXEN 500 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM
POVIDONE, UNSPECIFIED
MAGNESIUM STEARATE
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
MICROCRYSTALLINE CELLULOSE
Product Characteristics
Color ORANGE (Light orange) Score 2 pieces
Shape CAPSULE Size 16mm
Flavor Imprint Code G;32;500
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68462-190-30 30 TABLET in 1 BOTTLE None
2 NDC:68462-190-50 50 TABLET in 1 BOTTLE None
3 NDC:68462-190-01 100 TABLET in 1 BOTTLE None
4 NDC:68462-190-05 500 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078250 07/01/2007
NAPROXEN SODIUM naproxen sodium tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68462-178
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
POVIDONE, UNSPECIFIED
MAGNESIUM STEARATE
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
MICROCRYSTALLINE CELLULOSE
SILICON DIOXIDE
TALC
FD&C BLUE NO. 2
HYPROMELLOSE, UNSPECIFIED
POLYETHYLENE GLYCOL 400
TITANIUM DIOXIDE
Product Characteristics
Color BLUE Score no score
Shape OVAL Size 14mm
Flavor Imprint Code G;0;275
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68462-178-01 100 TABLET in 1 BOTTLE None
2 NDC:68462-178-05 500 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078314 08/01/2007
NAPROXEN SODIUM naproxen sodium tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68462-179
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
POVIDONE, UNSPECIFIED
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
SILICON DIOXIDE
TALC
FD&C BLUE NO. 2
HYPROMELLOSE, UNSPECIFIED
FERRIC OXIDE RED
POLYETHYLENE GLYCOL 400
TITANIUM DIOXIDE
Product Characteristics
Color BLUE Score 2 pieces
Shape CAPSULE (Bi-Convex) Size 19mm
Flavor Imprint Code G;0
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68462-179-01 100 TABLET in 1 BOTTLE None
2 NDC:68462-179-05 500 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078314 08/01/2007
Labeler — Glenmark Pharmaceuticals Inc., USA (130597813)
Establishment
Name Address ID/FEI Operations
Glenmark Pharmaceuticals Limited 677318665 ANALYSIS (68462-188), ANALYSIS (68462-189), ANALYSIS (68462-190), ANALYSIS (68462-178), ANALYSIS (68462-179), MANUFACTURE (68462-188), MANUFACTURE (68462-189), MANUFACTURE (68462-190), MANUFACTURE (68462-178), MANUFACTURE (68462-179)
Establishment
Name Address ID/FEI Operations
Glenmark Pharmaceuticals Limited 862603186 ANALYSIS (68462-178), ANALYSIS (68462-179), MANUFACTURE (68462-178), MANUFACTURE (68462-179)
Establishment
Name Address ID/FEI Operations
Glenmark Pharmaceuticals Inc., USA 079922908 MANUFACTURE (68462-178), MANUFACTURE (68462-179), ANALYSIS (68462-178), ANALYSIS (68462-179)

Revised: 05/2021 Glenmark Pharmaceuticals Inc., USA

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