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Principal Display Panel for Luvox CR 150 mg
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INGREDIENTS AND APPEARANCE
LUVOX CR
fluvoxamine maleate capsule, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68727-600
Route of Administration ORAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FLUVOXAMINE MALEATE (UNII: 5LGN83G74V) (FLUVOXAMINE - UNII:O4L1XPO44W) FLUVOXAMINE MALEATE 100 mg
Inactive Ingredients
Ingredient Name Strength
DIBUTYL SEBACATE (UNII: 4W5IH7FLNY)
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
GELATIN (UNII: 2G86QN327L)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
Product Characteristics
Color BLUE (dark blue opaque cap/white opaque body) Score no score
Shape CAPSULE (two-piece gelatin capsule) Size 19mm
Flavor Imprint Code LCR;100
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:68727-600-01 30 in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022033 02/28/2008
LUVOX CR
fluvoxamine maleate capsule, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68727-601
Route of Administration ORAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FLUVOXAMINE MALEATE (UNII: 5LGN83G74V) (FLUVOXAMINE - UNII:O4L1XPO44W) FLUVOXAMINE MALEATE 150 mg
Inactive Ingredients
Ingredient Name Strength
DIBUTYL SEBACATE (UNII: 4W5IH7FLNY)
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
GELATIN (UNII: 2G86QN327L)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
Product Characteristics
Color BLUE (dark blue opaque cap/powder blue opaque body) Score no score
Shape CAPSULE (two-piece gelatin capsule) Size 22mm
Flavor Imprint Code LCR;150
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:68727-601-01 30 in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022033 02/28/20
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