FDA.reportPublic FDA data

Fluoxetine

Product NDC
59651-309
11-digit product format
596510309
Labeler code
59651
Product ID
59651-309_fafde25d-094e-409f-be1c-cc086a0a8068
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluoxetine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA213286
Marketing category
ANDA
Marketing start
2020-04-08
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
Rxcui248642, 313990

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
59651-309-01Fluoxetine100 in 1 BOTTLETABLET, FILM COATED1007
59651-309-30Fluoxetine30 in 1 BOTTLETABLET, FILM COATED307

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59651-309-01EA - Each59651-3099a07ee67-afd2-4a89-9f33-c2b035b674fe12020-09-14
59651-309-30EA - Each59651-309dc6e8ab9-5c1c-4556-87ad-5e248328041212020-09-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59651-309FLUOXETINE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]7Current NDC, Legacy NDC, 2 package rows20240126_3daecd20-6a59-44d3-8269-4912214c08b4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
248642FLUoxetine 20 MG Oral TabletPSN3daecd20-6a59-44d3-8269-4912214c08b47
313990FLUoxetine HCl 10 MG Oral TabletPSN3daecd20-6a59-44d3-8269-4912214c08b47
313990fluoxetine 10 MG Oral TabletSCD3daecd20-6a59-44d3-8269-4912214c08b47
248642fluoxetine 20 MG Oral TabletSCD3daecd20-6a59-44d3-8269-4912214c08b47
313990fluoxetine 10 MG (as fluoxetine hydrochloride 11.2 MG) Oral TabletSY3daecd20-6a59-44d3-8269-4912214c08b47
248642fluoxetine 20 MG (as fluoxetine hydrochloride 22.4 MG) Oral TabletSY3daecd20-6a59-44d3-8269-4912214c08b47
248642FLUoxetine 20 MG Oral TabletPSN58b39e6a-3aae-4551-b081-586a4506aef21
248642fluoxetine 20 MG Oral TabletSCD58b39e6a-3aae-4551-b081-586a4506aef21
248642fluoxetine 20 MG (as fluoxetine hydrochloride 22.4 MG) Oral TabletSY58b39e6a-3aae-4551-b081-586a4506aef21

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
59651-309-0159651030901100 TABLET, FILM COATED in 1 BOTTLE (59651-309-01) 2020-04-080000-00-00NoNoCurrent
59651-309-305965103093030 TABLET, FILM COATED in 1 BOTTLE (59651-309-30) 2020-04-080000-00-00NoNoCurrent