NDC Code(s) : 68645-131-54
Packager : Legacy Pharmaceutical Packaging

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

FluoxetineFluoxetine CAPSULE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68645-131(NDC:50111-647)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FLUOXETINE HYDROCHLORIDE(UNII: I9W7N6B1KJ)
(FLUOXETINE - UNII:01K63SUP8D) 		FLUOXETINE HYDROCHLORIDE10 mg
Inactive Ingredients
Ingredient Name Strength
AMMONIA(UNII: 5138Q19F1X)
D&C YELLOW NO. 10(UNII: 35SW5USQ3G)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
GELATIN(UNII: 2G86QN327L)
MAGNESIUM STEARATE(UNII: 70097M6I30)
STARCH, CORN(UNII: O8232NY3SJ)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
SHELLAC(UNII: 46N107B71O)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Product Characteristics
Color WHITE, GREEN Score no score
Shape CAPSULE Size 16 mm
Flavor Imprint Code PLIVA;647
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:68645-131-5410 in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076001 01/31/2011

PRINCIPAL DISPLAY PANEL

NDC 68645-131-54
Fluoxetine
Capsules, USP
10mg
Rx Only
30 Capsules

NDC 68645-131-54 Fluoxetine Capsules, USP 10mg Rx Only 30 Capsules