FDA.reportPublic FDA data

Fluoxetine

Product NDC
72162-2221
11-digit product format
721622221
Labeler code
72162
Product ID
72162-2221_c289ffae-421b-4fa3-b4d5-9ccd1d7cecc6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluoxetine Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA204597
Marketing category
ANDA
Marketing start
2015-03-16
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Fluoxetine
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FLUOXETINE HYDROCHLORIDE40 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiI9W7N6B1KJ
Rxcui313989

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
72162-2221-5Fluoxetine500 in 1 BOTTLECAPSULE500103

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-2221-5EA - Each72162-22218e6aff7b-127d-4258-8f83-dc6d3473e23512024-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-2221FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [BRYANT RANCH PREPACK]102Current NDC, 1 package rows20240830_77d5c10a-0cfc-4b89-942c-0fb5c67ae409.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313989FLUoxetine 40 MG Oral CapsulePSN77d5c10a-0cfc-4b89-942c-0fb5c67ae409103
313989fluoxetine 40 MG Oral CapsuleSCD77d5c10a-0cfc-4b89-942c-0fb5c67ae409103
313989fluoxetine 40 MG (as fluoxetine HCl 44.8 MG) Oral CapsuleSY77d5c10a-0cfc-4b89-942c-0fb5c67ae409103

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72162-2221-572162222105500 CAPSULE in 1 BOTTLE (72162-2221-5) 500 capsule2015-03-16NoNoHistorical