Fluoxetine

Product NDC
45865-451
11-digit product format
458650451
Labeler code
45865
Product ID
45865-451_f25a460e-1569-4af3-ac4a-b99f44c51313
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluoxetine
Dosage form
CAPSULE
Route
ORAL
Labeler
Medsource Pharmaceuticals
Application
ANDA075465
Marketing category
ANDA
Marketing start
2009-06-09
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
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
45865-451-30Fluoxetine30 in 1 BOTTLECAPSULE303
45865-451-60Fluoxetine60 in 1 BOTTLECAPSULE603
45865-451-90Fluoxetine90 in 1 BOTTLECAPSULE903

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FLUOXETINE HYDROCHLORIDEACTIVE INGREDIENTI9W7N6B1KJFLUOXETINE CAPSULE [MEDSOURCE PHARMACEUTICALS]3
FLUOXETINEACTIVE MOIETY01K63SUP8DFLUOXETINE CAPSULE [MEDSOURCE PHARMACEUTICALS]3
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GFLUOXETINE CAPSULE [MEDSOURCE PHARMACEUTICALS]3
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDFLUOXETINE CAPSULE [MEDSOURCE PHARMACEUTICALS]3
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKFLUOXETINE CAPSULE [MEDSOURCE PHARMACEUTICALS]3
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAFLUOXETINE CAPSULE [MEDSOURCE PHARMACEUTICALS]3
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357FLUOXETINE CAPSULE [MEDSOURCE PHARMACEUTICALS]3
GELATININACTIVE INGREDIENT2G86QN327LFLUOXETINE CAPSULE [MEDSOURCE PHARMACEUTICALS]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4FLUOXETINE CAPSULE [MEDSOURCE PHARMACEUTICALS]3
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JFLUOXETINE CAPSULE [MEDSOURCE PHARMACEUTICALS]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJFLUOXETINE CAPSULE [MEDSOURCE PHARMACEUTICALS]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPFLUOXETINE CAPSULE [MEDSOURCE PHARMACEUTICALS]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45865-451FLUOXETINE CAPSULE [MEDSOURCE PHARMACEUTICALS]3Legacy NDC, 3 package rows20120812_0a2787f9-0166-4fa7-9f02-7d355609dabf.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310385FLUoxetine 20 MG Oral CapsulePSN0a2787f9-0166-4fa7-9f02-7d355609dabf3
310385fluoxetine 20 MG Oral CapsuleSCD0a2787f9-0166-4fa7-9f02-7d355609dabf3
310385fluoxetine 20 MG (as fluoxetine HCl 22.4 MG) Oral CapsuleSY0a2787f9-0166-4fa7-9f02-7d355609dabf3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
45865-451-304586504513030 in 1 BOTTLEHistorical
45865-451-604586504516060 in 1 BOTTLEHistorical
45865-451-904586504519090 in 1 BOTTLEHistorical