Fluoxetine

Product NDC
63187-089
11-digit product format
631870089
Labeler code
63187
Product ID
63187-089_0fd31fbf-d316-41d3-8a7a-7a69f291c399
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
fluoxetine
Dosage form
CAPSULE
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA076990
Marketing category
ANDA
Marketing start
2005-07-20
Marketing end
0000-00-00
Substance
FLUOXETINE HYDROCHLORIDE
Active strength
40 mg/1
Pharmacologic classes
Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-089-30EA - Each63187-0890b5c1da6-21ab-4d81-961c-d554db8f473212016-09-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FLUOXETINE HYDROCHLORIDEACTIVE INGREDIENTI9W7N6B1KJFLUOXETINE CAPSULE [PROFICIENT RX LP]2
FLUOXETINEACTIVE MOIETY01K63SUP8DFLUOXETINE CAPSULE [PROFICIENT RX LP]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GFLUOXETINE CAPSULE [PROFICIENT RX LP]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDFLUOXETINE CAPSULE [PROFICIENT RX LP]2
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKFLUOXETINE CAPSULE [PROFICIENT RX LP]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAFLUOXETINE CAPSULE [PROFICIENT RX LP]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8FLUOXETINE CAPSULE [PROFICIENT RX LP]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTFLUOXETINE CAPSULE [PROFICIENT RX LP]2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357FLUOXETINE CAPSULE [PROFICIENT RX LP]2
GELATININACTIVE INGREDIENT2G86QN327LFLUOXETINE CAPSULE [PROFICIENT RX LP]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30FLUOXETINE CAPSULE [PROFICIENT RX LP]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3FLUOXETINE CAPSULE [PROFICIENT RX LP]2
SHELLACINACTIVE INGREDIENT46N107B71OFLUOXETINE CAPSULE [PROFICIENT RX LP]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4FLUOXETINE CAPSULE [PROFICIENT RX LP]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJFLUOXETINE CAPSULE [PROFICIENT RX LP]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPFLUOXETINE CAPSULE [PROFICIENT RX LP]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-089FLUOXETINE CAPSULE [PROFICIENT RX LP]4Legacy NDC20191121_e3e8aa9d-9daf-4565-85c9-a8d79c46128b.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-089-306318700893030 CAPSULE in 1 BOTTLE (63187-089-30) 30 capsule2018-11-010000-00-00NoNoCurrent
63187-089-906318700899090 CAPSULE in 1 BOTTLE (63187-089-90) 90 capsule2018-11-010000-00-00NoNoCurrent