FDA.reportPublic FDA data

FLUOXETINE

Product NDC
72189-067
11-digit product format
721890067
Labeler code
72189
Product ID
72189-067_2be78ca4-349b-418a-e063-6294a90a0b01
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
FLUOXETINE HYDROCHLORIDE
Dosage form
CAPSULE
Route
ORAL
Labeler
DIRECT RX
Application
ANDA078619
Marketing category
ANDA
Marketing start
2020-01-07
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
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
72189-067-30FLUOXETINE30 in 1 BOTTLECAPSULE303
72189-067-90FLUOXETINE90 in 1 BOTTLECAPSULE903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72189-067-90EA - Each72189-0679efd522f-a2a6-49e0-a264-8543c071498812020-03-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72189-067FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [DIRECT RX]3Current NDC, Legacy NDC, 2 package rows20250119_9b8d8da5-8c06-0942-e053-2995a90aa2c9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313989FLUoxetine 40 MG Oral CapsulePSN9b8d8da5-8c06-0942-e053-2995a90aa2c93
313989fluoxetine 40 MG Oral CapsuleSCD9b8d8da5-8c06-0942-e053-2995a90aa2c93
313989fluoxetine 40 MG (as fluoxetine HCl 44.8 MG) Oral CapsuleSY9b8d8da5-8c06-0942-e053-2995a90aa2c93

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72189-067-307218900673030 CAPSULE in 1 BOTTLE (72189-067-30) 30 capsule2020-01-070000-00-00NoNoCurrent
72189-067-907218900679090 CAPSULE in 1 BOTTLE (72189-067-90) 90 capsule2020-01-070000-00-00NoNoCurrent