FDA.reportPublic FDA data

Fluoxetine

Product NDC
16714-721
11-digit product format
167140721
Labeler code
16714
Product ID
16714-721_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
20 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 HYDROCHLORIDE20 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
16714-721-02Fluoxetine100 in 1 BOTTLECAPSULE1007
16714-721-03Fluoxetine1000 in 1 BOTTLECAPSULE10007

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16714-721-02EA - Each16714-721c4faa033-c41f-4a6b-a832-e3d2a16f58be12021-03-02
16714-721-03EA - Each16714-7218cfd4f36-a42e-4631-b24a-3c2b991bc82312021-03-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16714-721FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [NORTHSTAR RX LLC]7Current NDC, Legacy NDC, 2 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
310385FLUoxetine 20 MG Oral CapsulePSN578ca8f8-86eb-4247-a0b3-50c3837a982e4
310385fluoxetine 20 MG Oral CapsuleSCD578ca8f8-86eb-4247-a0b3-50c3837a982e4
310385fluoxetine 20 MG (as fluoxetine HCl 22.4 MG) Oral CapsuleSY578ca8f8-86eb-4247-a0b3-50c3837a982e4
310385FLUoxetine 20 MG Oral CapsulePSN224c8c17-0183-4cd7-ab9e-0062f3c624f03
310385fluoxetine 20 MG Oral CapsuleSCD224c8c17-0183-4cd7-ab9e-0062f3c624f03
310385fluoxetine 20 MG (as fluoxetine HCl 22.4 MG) Oral CapsuleSY224c8c17-0183-4cd7-ab9e-0062f3c624f03
310385FLUoxetine 20 MG Oral CapsulePSN18e9f7f2-2d33-d139-e063-6294a90a30121
310385fluoxetine 20 MG Oral CapsuleSCD18e9f7f2-2d33-d139-e063-6294a90a30121
310385fluoxetine 20 MG (as fluoxetine HCl 22.4 MG) Oral CapsuleSY18e9f7f2-2d33-d139-e063-6294a90a30121

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
16714-721-0216714072102100 CAPSULE in 1 BOTTLE (16714-721-02) 100 capsule2008-01-310000-00-00NoNoCurrent
16714-721-03167140721031000 CAPSULE in 1 BOTTLE (16714-721-03) 1000 capsule2008-01-310000-00-00NoNoCurrent