FDA.reportPublic FDA data

Fluoxetine

Product NDC
43063-712
11-digit product format
430630712
Labeler code
43063
Product ID
43063-712_51186db3-5523-1b85-e063-6394a90a5df3
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
Marketing end
2028-02-29
Substance
FLUOXETINE HYDROCHLORIDE
Active strength
20 mg/1
Pharmacologic classes
Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Fluoxetine

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
43063-712-21Fluoxetine21 in 1 BOTTLE, PLASTICCAPSULE2139
43063-712-30Fluoxetine30 in 1 BOTTLE, PLASTICCAPSULE3039
43063-712-60Fluoxetine60 in 1 BOTTLE, PLASTICCAPSULE6039
43063-712-90Fluoxetine90 in 1 BOTTLE, PLASTICCAPSULE9039

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43063-712FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [PD-RX PHARMACEUTICALS, INC.]38Current NDC, Legacy NDC, 4 package rows20250121_b7b102f0-17a2-49f7-b898-cb2e0fc71b4d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310385FLUoxetine 20 MG Oral CapsulePSNb7b102f0-17a2-49f7-b898-cb2e0fc71b4d39
310385fluoxetine 20 MG Oral CapsuleSCDb7b102f0-17a2-49f7-b898-cb2e0fc71b4d39
310385fluoxetine 20 MG (as fluoxetine HCl 22.4 MG) Oral CapsuleSYb7b102f0-17a2-49f7-b898-cb2e0fc71b4d39

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43063-712-214306307122121 CAPSULE in 1 BOTTLE, PLASTIC (43063-712-21) 21 capsule2017-01-312028-02-29NoNoCurrent
43063-712-304306307123030 CAPSULE in 1 BOTTLE, PLASTIC (43063-712-30) 30 capsule2016-10-032028-02-29NoNoCurrent
43063-712-604306307126060 CAPSULE in 1 BOTTLE, PLASTIC (43063-712-60) 60 capsule2018-08-242028-02-29NoNoCurrent
43063-712-904306307129090 CAPSULE in 1 BOTTLE, PLASTIC (43063-712-90) 90 capsule2017-01-312028-02-29NoNoCurrent