FDA.reportPublic FDA data

Fluoxetine

Product NDC
43063-993
11-digit product format
430630993
Labeler code
43063
Product ID
43063-993_415f88da-1cac-b284-e063-6394a90a8b70
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluoxetine Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA078619
Marketing category
ANDA
Marketing start
2008-01-31
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
43063-993-21Fluoxetine21 in 1 BOTTLE, PLASTICCAPSULE2135
43063-993-30Fluoxetine30 in 1 BOTTLE, PLASTICCAPSULE3035
43063-993-90Fluoxetine90 in 1 BOTTLE, PLASTICCAPSULE9035

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43063-993FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [PD-RX PHARMACEUTICALS, INC.]34Current NDC, Legacy NDC, 3 package rows20241213_a5fa64a6-3de3-4e2e-8b92-6d507fb8eee9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313989FLUoxetine 40 MG Oral CapsulePSNa5fa64a6-3de3-4e2e-8b92-6d507fb8eee935
313989fluoxetine 40 MG Oral CapsuleSCDa5fa64a6-3de3-4e2e-8b92-6d507fb8eee935
313989fluoxetine 40 MG (as fluoxetine HCl 44.8 MG) Oral CapsuleSYa5fa64a6-3de3-4e2e-8b92-6d507fb8eee935

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43063-993-214306309932121 CAPSULE in 1 BOTTLE, PLASTIC (43063-993-21) 21 capsule2024-12-11NoNoCurrent
43063-993-304306309933030 CAPSULE in 1 BOTTLE, PLASTIC (43063-993-30) 30 capsule2019-06-200000-00-00NoNoCurrent
43063-993-904306309939090 CAPSULE in 1 BOTTLE, PLASTIC (43063-993-90) 90 capsule2019-07-080000-00-00NoNoCurrent