FDA.reportPublic FDA data

Fluoxetine

Product NDC
59651-900
11-digit product format
596510900
Labeler code
59651
Product ID
59651-900_d0f00a25-1aec-42fd-a301-d3710ae3e1f3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluoxetine
Dosage form
CAPSULE
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA078619
Marketing category
ANDA
Marketing start
2025-07-11
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
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 HYDROCHLORIDE40 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiI9W7N6B1KJ
Rxcui310384, 310385, 313989

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
59651-900-00Fluoxetine100 in 1 BOTTLECAPSULE1001
59651-900-05Fluoxetine500 in 1 BOTTLECAPSULE5001
59651-900-30Fluoxetine30 in 1 BOTTLECAPSULE301
59651-900-99Fluoxetine1000 in 1 BOTTLECAPSULE10001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59651-900-00EA - Each59651-900c310232b-5863-4d54-aa96-52285da058c212026-01-08
59651-900-05EA - Each59651-900e575b31a-33eb-44ca-a7b0-e8c8ac8dce4c12025-11-13
59651-900-30EA - Each59651-90054af18b3-1c74-4502-8b78-1ef578c8ca9512026-01-08
59651-900-99EA - Each59651-9006f1bcfd9-d109-4950-b535-3df0dda5f6c612025-11-13

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313989FLUoxetine 40 MG Oral CapsulePSN5dc20c8f-0d8f-400c-b850-fe1b7e3e75e34
313989fluoxetine 40 MG Oral CapsuleSCD5dc20c8f-0d8f-400c-b850-fe1b7e3e75e34
313989fluoxetine 40 MG (as fluoxetine HCl 44.8 MG) Oral CapsuleSY5dc20c8f-0d8f-400c-b850-fe1b7e3e75e34
310384FLUoxetine 10 MG Oral CapsulePSNd0f00a25-1aec-42fd-a301-d3710ae3e1f31
310385FLUoxetine 20 MG Oral CapsulePSNd0f00a25-1aec-42fd-a301-d3710ae3e1f31
313989FLUoxetine 40 MG Oral CapsulePSNd0f00a25-1aec-42fd-a301-d3710ae3e1f31
313989FLUoxetine 40 MG Oral CapsulePSNfaf4bc0c-bf65-4a65-8f08-3d800185d6a81
310384fluoxetine 10 MG Oral CapsuleSCDd0f00a25-1aec-42fd-a301-d3710ae3e1f31
310385fluoxetine 20 MG Oral CapsuleSCDd0f00a25-1aec-42fd-a301-d3710ae3e1f31
313989fluoxetine 40 MG Oral CapsuleSCDd0f00a25-1aec-42fd-a301-d3710ae3e1f31
313989fluoxetine 40 MG Oral CapsuleSCDfaf4bc0c-bf65-4a65-8f08-3d800185d6a81
310384fluoxetine 10 MG (as fluoxetine HCl 11.2 MG) Oral CapsuleSYd0f00a25-1aec-42fd-a301-d3710ae3e1f31
310385fluoxetine 20 MG (as fluoxetine HCl 22.4 MG) Oral CapsuleSYd0f00a25-1aec-42fd-a301-d3710ae3e1f31
313989fluoxetine 40 MG (as fluoxetine HCl 44.8 MG) Oral CapsuleSYd0f00a25-1aec-42fd-a301-d3710ae3e1f31
313989fluoxetine 40 MG (as fluoxetine HCl 44.8 MG) Oral CapsuleSYfaf4bc0c-bf65-4a65-8f08-3d800185d6a81

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
59651-900-0059651090000100 CAPSULE in 1 BOTTLE (59651-900-00) 100 capsule2025-07-11NoNoHistorical
59651-900-0559651090005500 CAPSULE in 1 BOTTLE (59651-900-05) 500 capsule2025-07-11NoNoHistorical
59651-900-305965109003030 CAPSULE in 1 BOTTLE (59651-900-30) 30 capsule2025-07-11NoNoHistorical
59651-900-99596510900991000 CAPSULE in 1 BOTTLE (59651-900-99) 1000 capsule2025-07-11NoNoHistorical