FDA.reportPublic FDA data

Fluoxetine

Product NDC
43063-839
11-digit product format
430630839
Labeler code
43063
Product ID
43063-839_32851291-33ce-2831-e063-6294a90a0d3a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluoxetine
Dosage form
CAPSULE
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA090223
Marketing category
ANDA
Marketing start
2016-01-29
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
43063-839-30Fluoxetine30 in 1 BOTTLE, PLASTICCAPSULE3016
43063-839-90Fluoxetine90 in 1 BOTTLE, PLASTICCAPSULE9016

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43063-839-30EA - Each43063-839c97309fc-b970-482e-bbe7-eeae3cca27c112019-07-02
43063-839-90EA - Each43063-839025e985c-700f-435b-9680-f39f9466871d12018-04-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43063-839FLUOXETINE CAPSULE [PD-RX PHARMACEUTICALS, INC.]16Current NDC, Legacy NDC, 2 package rows20250413_620ecf00-5473-4420-afd1-94b5b38e7301.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313989FLUoxetine 40 MG Oral CapsulePSN620ecf00-5473-4420-afd1-94b5b38e730116
313989fluoxetine 40 MG Oral CapsuleSCD620ecf00-5473-4420-afd1-94b5b38e730116
313989fluoxetine 40 MG (as fluoxetine HCl 44.8 MG) Oral CapsuleSY620ecf00-5473-4420-afd1-94b5b38e730116

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43063-839-304306308393030 CAPSULE in 1 BOTTLE, PLASTIC (43063-839-30) 30 capsule2016-01-290000-00-00NoNoCurrent
43063-839-904306308399090 CAPSULE in 1 BOTTLE, PLASTIC (43063-839-90) 90 capsule2018-03-060000-00-00NoNoCurrent