FDA.reportPublic FDA data

Fluoxetine

Product NDC
59651-308
11-digit product format
596510308
Labeler code
59651
Product ID
59651-308_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
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
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
59651-308-01Fluoxetine100 in 1 BOTTLETABLET, FILM COATED1007
59651-308-30Fluoxetine30 in 1 BOTTLETABLET, FILM COATED307

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59651-308-01EA - Each59651-308bf264590-8ce2-444a-b90b-e6823b2ab00c12020-09-14
59651-308-30EA - Each59651-308de1d5930-cec7-4c39-a1d8-f32d083280df12020-09-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59651-308FLUOXETINE 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
313990FLUoxetine HCl 10 MG Oral TabletPSN97e7929f-dec4-467d-93c2-93360884e9e9101
313990fluoxetine 10 MG Oral TabletSCD97e7929f-dec4-467d-93c2-93360884e9e9101
313990fluoxetine 10 MG (as fluoxetine hydrochloride 11.2 MG) Oral TabletSY97e7929f-dec4-467d-93c2-93360884e9e9101
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
313990FLUoxetine HCl 10 MG Oral TabletPSNac1651cc-4a2e-47cf-8a7e-be7ddcaf9f311
313990FLUoxetine HCl 10 MG Oral TabletPSNc1c7ec04-dd9e-400f-8f49-e900945fc61c1
313990fluoxetine 10 MG Oral TabletSCDac1651cc-4a2e-47cf-8a7e-be7ddcaf9f311
313990fluoxetine 10 MG Oral TabletSCDc1c7ec04-dd9e-400f-8f49-e900945fc61c1
313990fluoxetine 10 MG (as fluoxetine hydrochloride 11.2 MG) Oral TabletSYac1651cc-4a2e-47cf-8a7e-be7ddcaf9f311
313990fluoxetine 10 MG (as fluoxetine hydrochloride 11.2 MG) Oral TabletSYc1c7ec04-dd9e-400f-8f49-e900945fc61c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
59651-308-0159651030801100 TABLET, FILM COATED in 1 BOTTLE (59651-308-01) 2020-04-080000-00-00NoNoCurrent
59651-308-305965103083030 TABLET, FILM COATED in 1 BOTTLE (59651-308-30) 2020-04-080000-00-00NoNoCurrent
59651-308-61596510308616000 TABLET, FILM COATED in 1 BAG (59651-308-61)08-APR-20Current