Fluoxetine

Product NDC
55154-1341
11-digit product format
551541341
Labeler code
55154
Product ID
55154-1341_d6e86b2b-0fe3-44bb-9e06-63e2903f60e1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluoxetine
Dosage form
CAPSULE
Route
ORAL
Labeler
Cardinal Health
Application
ANDA076001
Marketing category
ANDA
Marketing start
2007-02-16
Marketing end
0000-00-00
Substance
FLUOXETINE HYDROCHLORIDE
Active strength
20 mg/1
Pharmacologic classes
Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FLUOXETINE HYDROCHLORIDEACTIVE INGREDIENTI9W7N6B1KJFLUOXETINE CAPSULE [CARDINAL HEALTH]6
FLUOXETINEACTIVE MOIETY01K63SUP8DFLUOXETINE CAPSULE [CARDINAL HEALTH]6
AMMONIAINACTIVE INGREDIENT5138Q19F1XFLUOXETINE CAPSULE [CARDINAL HEALTH]6
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GFLUOXETINE CAPSULE [CARDINAL HEALTH]6
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDFLUOXETINE CAPSULE [CARDINAL HEALTH]6
GELATININACTIVE INGREDIENT2G86QN327LFLUOXETINE CAPSULE [CARDINAL HEALTH]6
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30FLUOXETINE CAPSULE [CARDINAL HEALTH]6
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3FLUOXETINE CAPSULE [CARDINAL HEALTH]6
SHELLACINACTIVE INGREDIENT46N107B71OFLUOXETINE CAPSULE [CARDINAL HEALTH]6
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJFLUOXETINE CAPSULE [CARDINAL HEALTH]6
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPFLUOXETINE CAPSULE [CARDINAL HEALTH]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55154-1341FLUOXETINE CAPSULE [CARDINAL HEALTH 107, LLC]16Legacy NDC20240915_a74b5d70-d673-459f-a202-2b29b85cc851.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55154-1341-05515413410010 BLISTER PACK in 1 BAG (55154-1341-0) > 1 CAPSULE in 1 BLISTER PACK10 blister pack2007-02-160000-00-00NoNoCurrent