FDA.reportPublic FDA data

Fluoxetine HCL

Product NDC
72189-505
11-digit product format
721890505
Labeler code
72189
Product ID
72189-505_2c4e5941-7088-8be7-e063-6394a90a92e3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluoxetine HCL
Dosage form
CAPSULE
Route
ORAL
Labeler
Direct_Rx
Application
ANDA204597
Marketing category
ANDA
Marketing start
2023-08-07
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Fluoxetine HCL
Listing expiration
2026-12-31

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
72189-505-30Fluoxetine HCL30 in 1 BOTTLECAPSULE302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72189-505-30EA - Each72189-505c9ba4872-a637-46ff-bfdb-a6827ee86b4712023-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72189-505FLUOXETINE HCL CAPSULE [DIRECT_RX]2Current NDC, 1 package rows20250123_0259db51-e1ff-6e7a-e063-6394a90abace.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313989FLUoxetine 40 MG Oral CapsulePSN0259db51-e1ff-6e7a-e063-6394a90abace2
313989fluoxetine 40 MG Oral CapsuleSCD0259db51-e1ff-6e7a-e063-6394a90abace2
313989fluoxetine 40 MG (as fluoxetine HCl 44.8 MG) Oral CapsuleSY0259db51-e1ff-6e7a-e063-6394a90abace2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72189-505-307218905053030 CAPSULE in 1 BOTTLE (72189-505-30) 30 capsule2023-08-07NoNoHistorical