FLUOXETINE

Product NDC
61919-490
11-digit product format
619190490
Labeler code
61919
Product ID
61919-490_9c9402dc-ee8d-6c1f-e053-2995a90adabd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
FLUOXETINE
Dosage form
CAPSULE
Route
ORAL
Labeler
DirectRX
Application
ANDA076990
Marketing category
ANDA
Marketing start
2015-01-01
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
2021-12-31
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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61919-490-302023-01-30C16284748780-1f386c649-dfd9-0266-e053-dadaa90a7c1aFLUOXETINE
61919-490-902023-01-30C16284748780-1f386c649-dfd9-0266-e053-dadaa90a7c1aFLUOXETINE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-490-30FLUOXETINEHCL30 in 1 BOTTLECAPSULE304
61919-490-90FLUOXETINEHCL90 in 1 BOTTLECAPSULE904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-490-30EA - Each61919-4901b5ceab2-d6e6-4df5-8493-ad5a465dc9bb12016-02-04
61919-490-90EA - Each61919-49084c93db3-76dc-4116-ab48-651d8850db9612015-11-12

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-490FLUOXETINE HCL (FLUOXETINE) CAPSULE [DIRECTRX]4Legacy NDC, 2 package rows20200130_62e08a06-2f62-42aa-828f-5c2d1415657e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313989FLUoxetine 40 MG Oral CapsulePSN62e08a06-2f62-42aa-828f-5c2d1415657e4
313989fluoxetine 40 MG Oral CapsuleSCD62e08a06-2f62-42aa-828f-5c2d1415657e4
313989fluoxetine 40 MG (as fluoxetine HCl 44.8 MG) Oral CapsuleSY62e08a06-2f62-42aa-828f-5c2d1415657e4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61919-490-306191904903030 CAPSULE in 1 BOTTLE (61919-490-30) 30 capsule2015-12-030000-00-00NoNoCurrent
61919-490-906191904909090 CAPSULE in 1 BOTTLE (61919-490-90) 90 capsule2015-01-010000-00-00NoNoCurrent