Fluoxetine capsule

Ingredients and appearance - Product information

Fluoxetine capsule- Fluoxetine

Product information

Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC: 68071-4606
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Fluoxetine hydrochloride ( UNII: I9W7N6B1KJ)( Fluoxetine - UNII: 01K63SUP8D ) 10 mgin 1

Inactive Ingredients

Ingredient Name Code
D&c yellow no. 10 ( UNII: 35SW5USQ3G)
Fd&c blue no. 1 ( UNII: H3R47K3TBD)
Gelatin, unspecified ( 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 Imprint Code PLIVA;647;PLIVA;647
Score 1 Shape CAPSULE
Size 16 mm

Packaging

# Item Code Package Description Marketing Start Date
1 NDC: 68071-4606-3 30 in 1 BOTTLE 2018/10/19

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
ANDA ANDA076001 USA 2018/10/19

Labeler - NuCare Pharmaceuticals,Inc.( 010632300)

Establishment

Name ID/FEI Business Operations
NuCare Pharmaceuticals,Inc. 010632300 repack( 68071-4606)
Symbyax (olanzapine/fluoxetine HCL) is a fixed-dose combination of fluoxetine and olanzapine.
Incidence less than 1%.
Includes U.S. data for Major Depressive Disorder, OCD, Bulimia, and Panic Disorder clinical trials, plus non-U.S. data for Panic Disorder clinical trials.
Denominator used was for males only (N=690 fluoxetine Major Depressive Disorder; N=410 placebo Major Depressive Disorder; N=116 fluoxetine OCD; N=43 placebo OCD; N=14 fluoxetine bulimia; N=1 placebo bulimia; N=162 fluoxetine panic; N=121 placebo panic).
Incidence less than 1%.
Includes U.S. data for Major Depressive Disorder, OCD, Bulimia, and Panic Disorder clinical trials, plus non-U.S. data for Panic Disorder clinical trials.
Includes U.S. Major Depressive Disorder, OCD, Bulimia, and Panic Disorder clinical trials, plus non-U.S. Panic Disorder clinical trials.