Fluoxetine

Product NDC
0904-5784
11-digit product format
009045784
Labeler code
0904
Product ID
0904-5784_7eb87c3e-6bbc-4e57-a560-0d439a4e102b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluoxetine
Dosage form
CAPSULE
Route
ORAL
Labeler
Major Pharmaceuticals
Application
ANDA076001
Marketing category
ANDA
Marketing start
2007-02-16
Marketing end
0000-00-00
Substance
FLUOXETINE HYDROCHLORIDE
Active strength
10 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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-5784-61EA - Each0904-5784ac737092-d491-4392-8349-e74684c30d7012012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FLUOXETINE HYDROCHLORIDEACTIVE INGREDIENTI9W7N6B1KJFLUOXETINE CAPSULE [MAJOR PHARMACEUTICALS]9
FLUOXETINEACTIVE MOIETY01K63SUP8DFLUOXETINE CAPSULE [MAJOR PHARMACEUTICALS]9
AMMONIAINACTIVE INGREDIENT5138Q19F1XFLUOXETINE CAPSULE [MAJOR PHARMACEUTICALS]9
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GFLUOXETINE CAPSULE [MAJOR PHARMACEUTICALS]9
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDFLUOXETINE CAPSULE [MAJOR PHARMACEUTICALS]9
GELATININACTIVE INGREDIENT2G86QN327LFLUOXETINE CAPSULE [MAJOR PHARMACEUTICALS]9
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30FLUOXETINE CAPSULE [MAJOR PHARMACEUTICALS]9
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3FLUOXETINE CAPSULE [MAJOR PHARMACEUTICALS]9
SHELLACINACTIVE INGREDIENT46N107B71OFLUOXETINE CAPSULE [MAJOR PHARMACEUTICALS]9
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJFLUOXETINE CAPSULE [MAJOR PHARMACEUTICALS]9
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPFLUOXETINE CAPSULE [MAJOR PHARMACEUTICALS]9

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-5784FLUOXETINE CAPSULE [MAJOR PHARMACEUTICALS]16Legacy NDC20240910_0d97a780-be38-4f5e-ba45-d3b5be262c63.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0904-5784-6100904578461100 BLISTER PACK in 1 CARTON (0904-5784-61) > 1 CAPSULE in 1 BLISTER PACK100 blister pack2007-02-160000-00-00NoNoCurrent