FDA.reportPublic FDA data

Fluoxetine

Product NDC
59651-898
11-digit product format
596510898
Labeler code
59651
Product ID
59651-898_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
10 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 HYDROCHLORIDE10 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
59651-898-00Fluoxetine100 in 1 BOTTLECAPSULE1001
59651-898-05Fluoxetine500 in 1 BOTTLECAPSULE5001
59651-898-30Fluoxetine30 in 1 BOTTLECAPSULE301
59651-898-99Fluoxetine1000 in 1 BOTTLECAPSULE10001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59651-898-00EA - Each59651-898ada54aec-b9e8-4249-ae28-2c06a0a0d59c12025-11-13
59651-898-99EA - Each59651-898266edab0-cecd-409a-9708-ca34778989c612026-01-08

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310384FLUoxetine 10 MG Oral CapsulePSN50369762-c7c3-d58e-e063-6294a90af8df1
310384FLUoxetine 10 MG Oral CapsulePSNd0f00a25-1aec-42fd-a301-d3710ae3e1f31
310384FLUoxetine 10 MG Oral CapsulePSNd1c768b5-64bb-4036-aa92-797b3a5f92eb1
310385FLUoxetine 20 MG Oral CapsulePSNd0f00a25-1aec-42fd-a301-d3710ae3e1f31
313989FLUoxetine 40 MG Oral CapsulePSNd0f00a25-1aec-42fd-a301-d3710ae3e1f31
310384fluoxetine 10 MG Oral CapsuleSCD50369762-c7c3-d58e-e063-6294a90af8df1
310384fluoxetine 10 MG Oral CapsuleSCDd0f00a25-1aec-42fd-a301-d3710ae3e1f31
310384fluoxetine 10 MG Oral CapsuleSCDd1c768b5-64bb-4036-aa92-797b3a5f92eb1
310385fluoxetine 20 MG Oral CapsuleSCDd0f00a25-1aec-42fd-a301-d3710ae3e1f31
313989fluoxetine 40 MG Oral CapsuleSCDd0f00a25-1aec-42fd-a301-d3710ae3e1f31
310384fluoxetine 10 MG (as fluoxetine HCl 11.2 MG) Oral CapsuleSY50369762-c7c3-d58e-e063-6294a90af8df1
310384fluoxetine 10 MG (as fluoxetine HCl 11.2 MG) Oral CapsuleSYd0f00a25-1aec-42fd-a301-d3710ae3e1f31
310384fluoxetine 10 MG (as fluoxetine HCl 11.2 MG) Oral CapsuleSYd1c768b5-64bb-4036-aa92-797b3a5f92eb1
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
59651-898-0059651089800100 CAPSULE in 1 BOTTLE (59651-898-00) 100 capsule2025-07-11NoNoHistorical
59651-898-0559651089805500 CAPSULE in 1 BOTTLE (59651-898-05) 500 capsule2025-07-11NoNoHistorical
59651-898-305965108983030 CAPSULE in 1 BOTTLE (59651-898-30) 30 capsule2025-07-11NoNoHistorical
59651-898-99596510898991000 CAPSULE in 1 BOTTLE (59651-898-99) 1000 capsule2025-07-11NoNoHistorical