FDA.reportPublic FDA data

Fluoxetine

Product NDC
0615-8183
11-digit product format
006158183
Labeler code
0615
Product ID
0615-8183_1cbaceb2-e30c-4a5d-b4af-bf614d41b348
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluoxetine Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
NCS HealthCare of KY, LLC dba Vangard Labs
Application
ANDA078619
Marketing category
ANDA
Marketing start
2008-01-31
Marketing end
2026-10-31
Substance
FLUOXETINE HYDROCHLORIDE
Active strength
40 mg/1
Pharmacologic classes
Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Fluoxetine

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FLUOXETINE HYDROCHLORIDE40 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiI9W7N6B1KJ
Rxcui313989

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0615-8183-05Fluoxetine15 in 1 BLISTER PACKCAPSULE1532
0615-8183-39Fluoxetine30 in 1 BLISTER PACKCAPSULE3032

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0615-8183FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [NCS HEALTHCARE OF KY, LLC DBA VANGARD LABS]31Current NDC, Legacy NDC, 2 package rows20230921_9f069b9b-16e4-4f0e-b420-4aa02ffbb632.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313989FLUoxetine 40 MG Oral CapsulePSN9f069b9b-16e4-4f0e-b420-4aa02ffbb63232
313989fluoxetine 40 MG Oral CapsuleSCD9f069b9b-16e4-4f0e-b420-4aa02ffbb63232
313989fluoxetine 40 MG (as fluoxetine HCl 44.8 MG) Oral CapsuleSY9f069b9b-16e4-4f0e-b420-4aa02ffbb63232

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0615-8183-050061581830515 CAPSULE in 1 BLISTER PACK (0615-8183-05) 15 capsule2023-09-112026-10-31NoNoHistorical
0615-8183-390061581833930 CAPSULE in 1 BLISTER PACK (0615-8183-39) 30 capsule2018-03-222026-10-31NoNoCurrent