Fluoxetine Hydrochloride (Page 13 of 13)

FLUOXETINE HYDROCHLORIDE TABLET

Label Image
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FLUOXETINE HYDROCHLORIDE fluoxetine hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:53002-1796(NDC:68180-998)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FLUOXETINE HYDROCHLORIDE (FLUOXETINE) FLUOXETINE 10 mg
Inactive Ingredients
Ingredient Name Strength
MICROCRYSTALLINE CELLULOSE
CROSCARMELLOSE SODIUM
MAGNESIUM STEARATE
MANNITOL
POLYETHYLENE GLYCOL 3350
POLYVINYL ALCOHOL, UNSPECIFIED
POVIDONE K30
SILICON DIOXIDE
TALC
TITANIUM DIOXIDE
Product Characteristics
Color WHITE (to off-white) Score 2 pieces
Shape OVAL Size 9mm
Flavor Imprint Code L;U;F55
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:53002-1796-0 100 TABLET in 1 BOTTLE None
2 NDC:53002-1796-3 30 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA211653 08/07/2019
Labeler — RPK Pharmaceuticals, Inc. (147096275)
Establishment
Name Address ID/FEI Operations
RPK Pharmaceuticals, Inc. 147096275 RELABEL (53002-1796), REPACK (53002-1796)

Revised: 01/2023 RPK Pharmaceuticals, Inc.

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