Fluoxetine

Product NDC
72162-1506
11-digit product format
721621506
Labeler code
72162
Product ID
72162-1506_cf0b39d7-583f-43cc-9737-e28c00ff392c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluoxetine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA209419
Marketing category
ANDA
Marketing start
2017-11-16
Substance
FLUOXETINE HYDROCHLORIDE
Active strength
60 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 HYDROCHLORIDE60 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiI9W7N6B1KJ
Rxcui1190110

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
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
e7177a8f-11de-ee90-ca22-068e6ef54cf5Product name420230104
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
82da1192-6e97-fa73-2f85-6a50c10b4704Product name320161212
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
877783eb-030c-6e3f-0979-804cf94d8856Product name120140508
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72162-1506-3Fluoxetine30 in 1 BOTTLETABLET, FILM COATED30103

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-1506-3EA - Each72162-15062bd335fc-bacb-43c2-835d-1612322b066f12023-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-1506FLUOXETINE TABLET, FILM COATED [BRYANT RANCH PREPACK]103Current NDC, 1 package rows20240413_dced86a0-fc08-465c-897c-f8899e6206d5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1190110FLUoxetine HCl 60 MG Oral TabletPSNdced86a0-fc08-465c-897c-f8899e6206d5103
1190110fluoxetine 60 MG Oral TabletSCDdced86a0-fc08-465c-897c-f8899e6206d5103
1190110fluoxetine (as fluoxetine HCl) 60 MG Oral TabletSYdced86a0-fc08-465c-897c-f8899e6206d5103

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72162-1506-37216215060330 TABLET, FILM COATED in 1 BOTTLE (72162-1506-3) 2024-04-08NoNoCurrent