Fluoxetine

Product NDC
76365-0101
11-digit product format
763650101
Labeler code
76365
Product ID
76365-0101_f719162f-cb78-487c-b172-ac10d009e6f5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluoxetine hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Prodigy Health Supplier
Application
ANDA075464
Marketing category
ANDA
Marketing start
2012-06-01
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
E
Listing certified through
2017-12-31
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
76365-0101-2Fluoxetine100 in 1 BOTTLECAPSULE1001
76365-0101-4Fluoxetine500 in 1 BOTTLECAPSULE5001
76365-0101-6Fluoxetine1000 in 1 BOTTLECAPSULE10001

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Fluoxetine hydrochlorideACTIVE INGREDIENTI9W7N6B1KJFLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [PRODIGY HEALTH SUPPLIER]1
FluoxetineACTIVE MOIETY01K63SUP8DFLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [PRODIGY HEALTH SUPPLIER]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MFLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [PRODIGY HEALTH SUPPLIER]1
AMMONIAINACTIVE INGREDIENT5138Q19F1XFLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [PRODIGY HEALTH SUPPLIER]1
BUTYL ALCOHOLINACTIVE INGREDIENT8PJ61P6TS3FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [PRODIGY HEALTH SUPPLIER]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UFLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [PRODIGY HEALTH SUPPLIER]1
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1OFLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [PRODIGY HEALTH SUPPLIER]1
GELATININACTIVE INGREDIENT2G86QN327LFLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [PRODIGY HEALTH SUPPLIER]1
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [PRODIGY HEALTH SUPPLIER]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XFLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [PRODIGY HEALTH SUPPLIER]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [PRODIGY HEALTH SUPPLIER]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [PRODIGY HEALTH SUPPLIER]1
SHELLACINACTIVE INGREDIENT46N107B71OFLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [PRODIGY HEALTH SUPPLIER]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [PRODIGY HEALTH SUPPLIER]1
THIAMINEINACTIVE INGREDIENTX66NSO3N35FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [PRODIGY HEALTH SUPPLIER]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPFLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [PRODIGY HEALTH SUPPLIER]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76365-0101FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [PRODIGY HEALTH SUPPLIER]1Legacy NDC, 3 package rows20120601_f719162f-cb78-487c-b172-ac10d009e6f5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310384FLUoxetine 10 MG Oral CapsulePSNf719162f-cb78-487c-b172-ac10d009e6f51
310385FLUoxetine 20 MG Oral CapsulePSNf719162f-cb78-487c-b172-ac10d009e6f51
310384fluoxetine 10 MG Oral CapsuleSCDf719162f-cb78-487c-b172-ac10d009e6f51
310385fluoxetine 20 MG Oral CapsuleSCDf719162f-cb78-487c-b172-ac10d009e6f51
310384fluoxetine 10 MG (as fluoxetine HCl 11.2 MG) Oral CapsuleSYf719162f-cb78-487c-b172-ac10d009e6f51
310385fluoxetine 20 MG (as fluoxetine HCl 22.4 MG) Oral CapsuleSYf719162f-cb78-487c-b172-ac10d009e6f51

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
76365-0101-276365010102100 in 1 BOTTLEHistorical
76365-0101-476365010104500 in 1 BOTTLEHistorical
76365-0101-6763650101061000 in 1 BOTTLEHistorical