FDA.reportPublic FDA data

Fluoxetine

Product NDC
83209-721
11-digit product format
832090721
Labeler code
83209
Product ID
83209-721_18e9f058-31ba-cc99-e063-6294a90a0fee
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluoxetine
Dosage form
CAPSULE
Route
ORAL
Labeler
Boswell Pharmacy Services LLC d/b/a BPS Wholesale
Application
ANDA078619
Marketing category
ANDA
Marketing start
2024-05-20
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
Rxcui310385

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
83209-721-06Fluoxetine6 in 1 BLISTER PACKCAPSULE61
83209-721-10Fluoxetine10 in 1 BLISTER PACKCAPSULE101
83209-721-15Fluoxetine15 in 1 BLISTER PACKCAPSULE151
83209-721-20Fluoxetine20 in 1 BLISTER PACKCAPSULE201
83209-721-30Fluoxetine30 in 1 BLISTER PACKCAPSULE301
83209-721-60Fluoxetine60 in 1 BLISTER PACKCAPSULE601

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310385FLUoxetine 20 MG Oral CapsulePSN18e9f7f2-2d33-d139-e063-6294a90a30121
310385fluoxetine 20 MG Oral CapsuleSCD18e9f7f2-2d33-d139-e063-6294a90a30121
310385fluoxetine 20 MG (as fluoxetine HCl 22.4 MG) Oral CapsuleSY18e9f7f2-2d33-d139-e063-6294a90a30121

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83209-721-06832090721066 CAPSULE in 1 BLISTER PACK (83209-721-06) 6 capsule2024-05-20NoNoHistorical
83209-721-108320907211010 CAPSULE in 1 BLISTER PACK (83209-721-10) 10 capsule2024-05-20NoNoHistorical
83209-721-158320907211515 CAPSULE in 1 BLISTER PACK (83209-721-15) 15 capsule2024-05-20NoNoHistorical
83209-721-208320907212020 CAPSULE in 1 BLISTER PACK (83209-721-20) 20 capsule2024-05-20NoNoHistorical
83209-721-308320907213030 CAPSULE in 1 BLISTER PACK (83209-721-30) 30 capsule2024-05-20NoNoHistorical
83209-721-608320907216060 CAPSULE in 1 BLISTER PACK (83209-721-60) 60 capsule2024-05-20NoNoHistorical