FDA.reportPublic FDA data

Fluoxetine

Product NDC
83209-192
11-digit product format
832090192
Labeler code
83209
Product ID
83209-192_1fd02569-04f0-e34e-e063-6394a90a227b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluoxetine Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Boswell Pharmacy Services LLC d/b/a BPS Wholesale
Application
ANDA078619
Marketing category
ANDA
Marketing start
2024-08-16
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

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
83209-192-10Fluoxetine10 in 1 BLISTER PACKCAPSULE101
83209-192-15Fluoxetine15 in 1 BLISTER PACKCAPSULE151
83209-192-30Fluoxetine30 in 1 BLISTER PACKCAPSULE301
83209-192-60Fluoxetine60 in 1 BLISTER PACKCAPSULE601

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310384FLUoxetine 10 MG Oral CapsulePSN1fd00b7f-df07-455f-e063-6394a90a1f101
310384fluoxetine 10 MG Oral CapsuleSCD1fd00b7f-df07-455f-e063-6394a90a1f101
310384fluoxetine 10 MG (as fluoxetine HCl 11.2 MG) Oral CapsuleSY1fd00b7f-df07-455f-e063-6394a90a1f101

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83209-192-108320901921010 CAPSULE in 1 BLISTER PACK (83209-192-10) 10 capsule2024-08-16NoNoCurrent
83209-192-158320901921515 CAPSULE in 1 BLISTER PACK (83209-192-15) 15 capsule2024-08-16NoNoCurrent
83209-192-308320901923030 CAPSULE in 1 BLISTER PACK (83209-192-30) 30 capsule2024-08-16NoNoCurrent
83209-192-608320901926060 CAPSULE in 1 BLISTER PACK (83209-192-60) 60 capsule2024-08-16NoNoCurrent