FDA.reportPublic FDA data

Fluoxetine

Product NDC
0615-7625
11-digit product format
006157625
Labeler code
0615
Product ID
0615-7625_e0e2906e-e311-4a3d-a9bd-3764f1b4cf34
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluoxetine
Dosage form
CAPSULE
Route
ORAL
Labeler
NCS HealthCare of KY, LLC dba Vangard Labs
Application
ANDA076001
Marketing category
ANDA
Marketing start
2002-01-29
Substance
FLUOXETINE HYDROCHLORIDE
Active strength
20 mg/1
Pharmacologic classes
Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Fluoxetine
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FLUOXETINE HYDROCHLORIDE20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiI9W7N6B1KJ
Rxcui310384, 310385

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
0615-7625-05Fluoxetine15 in 1 BLISTER PACKCAPSULE1533
0615-7625-39Fluoxetine30 in 1 BLISTER PACKCAPSULE3033

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0615-7625FLUOXETINE CAPSULE [NCS HEALTHCARE OF KY, LLC DBA VANGARD LABS]15Current NDC, Legacy NDC, 2 package rows20220629_647e17f5-a15a-4e77-922c-24a5db2118bc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310384FLUoxetine 10 MG Oral CapsulePSN647e17f5-a15a-4e77-922c-24a5db2118bc33
310385FLUoxetine 20 MG Oral CapsulePSN647e17f5-a15a-4e77-922c-24a5db2118bc33
310384fluoxetine 10 MG Oral CapsuleSCD647e17f5-a15a-4e77-922c-24a5db2118bc33
310385fluoxetine 20 MG Oral CapsuleSCD647e17f5-a15a-4e77-922c-24a5db2118bc33
310384fluoxetine 10 MG (as fluoxetine HCl 11.2 MG) Oral CapsuleSY647e17f5-a15a-4e77-922c-24a5db2118bc33
310385fluoxetine 20 MG (as fluoxetine HCl 22.4 MG) Oral CapsuleSY647e17f5-a15a-4e77-922c-24a5db2118bc33

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0615-7625-050061576250515 CAPSULE in 1 BLISTER PACK (0615-7625-05) 15 capsule2019-04-150000-00-00NoNoCurrent
0615-7625-390061576253930 CAPSULE in 1 BLISTER PACK (0615-7625-39) 30 capsule2011-05-200000-00-00NoNoCurrent