FDA.reportPublic FDA data

Fluoxetine

Product NDC
71205-974
11-digit product format
712050974
Labeler code
71205
Product ID
71205-974_14464dfb-94a5-43a1-923e-d462b7ade131
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluoxetine Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA204597
Marketing category
ANDA
Marketing start
2019-09-25
Substance
FLUOXETINE HYDROCHLORIDE
Active strength
10 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 HYDROCHLORIDE10 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
71205-974-00Fluoxetine100 in 1 BOTTLECAPSULE1003
71205-974-11Fluoxetine1000 in 1 BOTTLECAPSULE10003
71205-974-30Fluoxetine30 in 1 BOTTLECAPSULE303
71205-974-55Fluoxetine500 in 1 BOTTLECAPSULE5003
71205-974-60Fluoxetine60 in 1 BOTTLECAPSULE603
71205-974-72Fluoxetine120 in 1 BOTTLECAPSULE1203
71205-974-90Fluoxetine90 in 1 BOTTLECAPSULE903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-974-00EA - Each71205-97432e4b24a-7f44-43ac-8235-c649dea325f712021-06-02
71205-974-11EA - Each71205-974f8c027a8-1a19-48a2-af76-53966bcc5e7412021-06-02
71205-974-30EA - Each71205-9745f2017ad-a65b-4257-8aad-16c6f1bc119012021-06-02
71205-974-55EA - Each71205-974470463c7-b2de-4458-a65d-f4b5c45de60212021-06-02
71205-974-60EA - Each71205-9742dae18e4-eb0d-495e-9379-83322e6762af12021-06-02
71205-974-72EA - Each71205-974b53d51fd-02a2-4eac-8dce-e6b32cccc5b112021-06-02
71205-974-90EA - Each71205-9745cc5a7a6-af15-41bb-b660-b70a5637576512021-06-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-974FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [PROFICIENT RX LP]3Current NDC, Legacy NDC, 7 package rows20220402_57f21f2b-0ec2-49dc-911a-806e5ae880c2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310384FLUoxetine 10 MG Oral CapsulePSN57f21f2b-0ec2-49dc-911a-806e5ae880c23
310385FLUoxetine 20 MG Oral CapsulePSN57f21f2b-0ec2-49dc-911a-806e5ae880c23
313989FLUoxetine 40 MG Oral CapsulePSN57f21f2b-0ec2-49dc-911a-806e5ae880c23
310384fluoxetine 10 MG Oral CapsuleSCD57f21f2b-0ec2-49dc-911a-806e5ae880c23
310385fluoxetine 20 MG Oral CapsuleSCD57f21f2b-0ec2-49dc-911a-806e5ae880c23
313989fluoxetine 40 MG Oral CapsuleSCD57f21f2b-0ec2-49dc-911a-806e5ae880c23
310384fluoxetine 10 MG (as fluoxetine HCl 11.2 MG) Oral CapsuleSY57f21f2b-0ec2-49dc-911a-806e5ae880c23
310385fluoxetine 20 MG (as fluoxetine HCl 22.4 MG) Oral CapsuleSY57f21f2b-0ec2-49dc-911a-806e5ae880c23
313989fluoxetine 40 MG (as fluoxetine HCl 44.8 MG) Oral CapsuleSY57f21f2b-0ec2-49dc-911a-806e5ae880c23

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71205-974-0071205097400100 CAPSULE in 1 BOTTLE (71205-974-00) 100 capsule2020-05-070000-00-00NoNoCurrent
71205-974-11712050974111000 CAPSULE in 1 BOTTLE (71205-974-11) 1000 capsule2020-05-070000-00-00NoNoCurrent
71205-974-307120509743030 CAPSULE in 1 BOTTLE (71205-974-30) 30 capsule2020-05-070000-00-00NoNoCurrent
71205-974-5571205097455500 CAPSULE in 1 BOTTLE (71205-974-55) 500 capsule2020-05-070000-00-00NoNoCurrent
71205-974-607120509746060 CAPSULE in 1 BOTTLE (71205-974-60) 60 capsule2020-05-070000-00-00NoNoCurrent
71205-974-7271205097472120 CAPSULE in 1 BOTTLE (71205-974-72) 120 capsule2020-05-070000-00-00NoNoCurrent
71205-974-907120509749090 CAPSULE in 1 BOTTLE (71205-974-90) 90 capsule2020-05-070000-00-00NoNoCurrent