FDA.reportPublic FDA data

Fluoxetine

Product NDC
16714-722
11-digit product format
167140722
Labeler code
16714
Product ID
16714-722_a7fb6b36-0508-4287-83c0-976f0f767265
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluoxetine Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
NorthStar Rx LLC
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
Rxcui310384, 310385, 313989

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
16714-722-02Fluoxetine100 in 1 BOTTLECAPSULE1007
16714-722-03Fluoxetine500 in 1 BOTTLECAPSULE5007
16714-722-04Fluoxetine1000 in 1 BOTTLECAPSULE10007

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16714-722-02EA - Each16714-722f3ae872b-e6f5-4a4e-a055-7feab63d249612021-03-02
16714-722-03EA - Each16714-72265a381ae-a969-4f1b-bd43-187ee57b7fe412021-03-02
16714-722-04EA - Each16714-722cac68412-9a0b-40ea-be5b-a84d69ac52bb12021-03-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16714-722FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [NORTHSTAR RX LLC]7Current NDC, Legacy NDC, 3 package rows20240215_97960730-432e-4e94-bb4e-62a3157270a8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310384FLUoxetine 10 MG Oral CapsulePSN97960730-432e-4e94-bb4e-62a3157270a87
310385FLUoxetine 20 MG Oral CapsulePSN97960730-432e-4e94-bb4e-62a3157270a87
313989FLUoxetine 40 MG Oral CapsulePSN97960730-432e-4e94-bb4e-62a3157270a87
310384fluoxetine 10 MG Oral CapsuleSCD97960730-432e-4e94-bb4e-62a3157270a87
310385fluoxetine 20 MG Oral CapsuleSCD97960730-432e-4e94-bb4e-62a3157270a87
313989fluoxetine 40 MG Oral CapsuleSCD97960730-432e-4e94-bb4e-62a3157270a87
310384fluoxetine 10 MG (as fluoxetine HCl 11.2 MG) Oral CapsuleSY97960730-432e-4e94-bb4e-62a3157270a87
310385fluoxetine 20 MG (as fluoxetine HCl 22.4 MG) Oral CapsuleSY97960730-432e-4e94-bb4e-62a3157270a87
313989fluoxetine 40 MG (as fluoxetine HCl 44.8 MG) Oral CapsuleSY97960730-432e-4e94-bb4e-62a3157270a87
313989FLUoxetine 40 MG Oral CapsulePSN3fba8d68-0663-4053-93ee-7531246fd47d3
313989fluoxetine 40 MG Oral CapsuleSCD3fba8d68-0663-4053-93ee-7531246fd47d3
313989fluoxetine 40 MG (as fluoxetine HCl 44.8 MG) Oral CapsuleSY3fba8d68-0663-4053-93ee-7531246fd47d3
313989FLUoxetine 40 MG Oral CapsulePSN08f3c11c-9ba0-4c53-bf31-264725e611ea1
313989fluoxetine 40 MG Oral CapsuleSCD08f3c11c-9ba0-4c53-bf31-264725e611ea1
313989fluoxetine 40 MG (as fluoxetine HCl 44.8 MG) Oral CapsuleSY08f3c11c-9ba0-4c53-bf31-264725e611ea1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
16714-722-0216714072202100 CAPSULE in 1 BOTTLE (16714-722-02) 100 capsule2008-01-310000-00-00NoNoCurrent
16714-722-0316714072203500 CAPSULE in 1 BOTTLE (16714-722-03) 500 capsule2008-01-310000-00-00NoNoCurrent
16714-722-04167140722041000 CAPSULE in 1 BOTTLE (16714-722-04) 1000 capsule2008-01-310000-00-00NoNoCurrent