Fluoxetine

Product NDC
50436-0923
11-digit product format
504360923
Labeler code
50436
Product ID
50436-0923_7675fb6d-3904-4b34-8039-5bda7632d156
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
fluoxetine
Dosage form
CAPSULE
Route
ORAL
Labeler
Unit Dose Services
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
E
Listing certified through
2018-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ce7d40ce-bfb8-ee15-a060-423ec90d7ac9Product name620250331
e5b459e3-ddce-4802-aab4-2c901d71ae85Product name520250129
6d3d5b3a-d6b8-8417-8428-6414b08f1464Product name320240130
e7177a8f-11de-ee90-ca22-068e6ef54cf5Product name420230104
82da1192-6e97-fa73-2f85-6a50c10b4704Product name320161212
877783eb-030c-6e3f-0979-804cf94d8856Product name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50436-0923-1Fluoxetine30 in 1 BOTTLECAPSULE302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50436-0923-1EA - Each50436-0923827c616d-0ede-4cfa-a9a8-edc15b54189b12013-06-04

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50436-0923FLUOXETINE CAPSULE [UNIT DOSE SERVICES]2Legacy NDC, 1 package rows20130521_6b8ebc39-da88-4491-bbf0-9be758c2ddfc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313989FLUoxetine 40 MG Oral CapsulePSN6b8ebc39-da88-4491-bbf0-9be758c2ddfc2
313989fluoxetine 40 MG Oral CapsuleSCD6b8ebc39-da88-4491-bbf0-9be758c2ddfc2
313989fluoxetine 40 MG (as fluoxetine HCl 44.8 MG) Oral CapsuleSY6b8ebc39-da88-4491-bbf0-9be758c2ddfc2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
50436-0923-15043609230130 in 1 BOTTLEHistorical