FDA.reportPublic FDA data

Fluoxetine

Product NDC
45865-174
11-digit product format
458650174
Labeler code
45865
Product ID
45865-174_1302fc08-d5fb-54b4-e063-6394a90a5275
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluoxetine Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Medsource Pharmaceuticals
Application
ANDA204597
Marketing category
ANDA
Marketing start
2015-03-16
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
Rxcui310385

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
45865-174-30Fluoxetine30 in 1 BOTTLECAPSULE301
45865-174-60Fluoxetine60 in 1 BOTTLECAPSULE601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45865-174FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [MEDSOURCE PHARMACEUTICALS]1Current NDC, 2 package rows20240308_1302fc08-d5fa-54b4-e063-6394a90a5275.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310385FLUoxetine 20 MG Oral CapsulePSN1302fc08-d5fa-54b4-e063-6394a90a52751
310385fluoxetine 20 MG Oral CapsuleSCD1302fc08-d5fa-54b4-e063-6394a90a52751
310385fluoxetine 20 MG (as fluoxetine HCl 22.4 MG) Oral CapsuleSY1302fc08-d5fa-54b4-e063-6394a90a52751

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
45865-174-304586501743030 CAPSULE in 1 BOTTLE (45865-174-30) 30 capsule2021-09-08NoNoCurrent
45865-174-604586501746060 CAPSULE in 1 BOTTLE (45865-174-60) 60 capsule2021-04-15NoNoCurrent