FDA.reportPublic FDA data

Fluoxetine

Product NDC
69367-236
11-digit product format
693670236
Labeler code
69367
Product ID
69367-236_2c8c16fd-61b1-4d89-bbc5-66d4d7c0a770
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluoxetine Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Westminster Pharmaceuticals, LLC
Application
ANDA204597
Marketing category
ANDA
Marketing start
2019-09-25
Marketing end
2026-08-01
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
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
69367-236-01Fluoxetine100 in 1 BOTTLECAPSULE1006
69367-236-10Fluoxetine1000 in 1 BOTTLECAPSULE10006

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69367-236-01EA - Each69367-23676da3fed-c75c-4a64-a7b7-f7f74ab804f712020-02-13
69367-236-10EA - Each69367-2364a82bc97-8de0-4f6d-a5fa-0dd5fcfe156212020-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69367-236FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [WESTMINSTER PHARMACEUTICALS, LLC]5Current NDC, Legacy NDC, 2 package rows20240612_8c4b2119-8cec-4b4b-9a52-ae763fd9b252.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310384FLUoxetine 10 MG Oral CapsulePSN8c4b2119-8cec-4b4b-9a52-ae763fd9b2526
310385FLUoxetine 20 MG Oral CapsulePSN8c4b2119-8cec-4b4b-9a52-ae763fd9b2526
313989FLUoxetine 40 MG Oral CapsulePSN8c4b2119-8cec-4b4b-9a52-ae763fd9b2526
310384fluoxetine 10 MG Oral CapsuleSCD8c4b2119-8cec-4b4b-9a52-ae763fd9b2526
310385fluoxetine 20 MG Oral CapsuleSCD8c4b2119-8cec-4b4b-9a52-ae763fd9b2526
313989fluoxetine 40 MG Oral CapsuleSCD8c4b2119-8cec-4b4b-9a52-ae763fd9b2526
310384fluoxetine 10 MG (as fluoxetine HCl 11.2 MG) Oral CapsuleSY8c4b2119-8cec-4b4b-9a52-ae763fd9b2526
310385fluoxetine 20 MG (as fluoxetine HCl 22.4 MG) Oral CapsuleSY8c4b2119-8cec-4b4b-9a52-ae763fd9b2526
313989fluoxetine 40 MG (as fluoxetine HCl 44.8 MG) Oral CapsuleSY8c4b2119-8cec-4b4b-9a52-ae763fd9b2526
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
310385FLUoxetine 20 MG Oral CapsulePSNa5d49dee-a7de-44d8-80b5-1aeb89e769381
310385fluoxetine 20 MG Oral CapsuleSCDa5d49dee-a7de-44d8-80b5-1aeb89e769381
310385fluoxetine 20 MG (as fluoxetine HCl 22.4 MG) Oral CapsuleSYa5d49dee-a7de-44d8-80b5-1aeb89e769381

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69367-236-0169367023601100 CAPSULE in 1 BOTTLE (69367-236-01) 100 capsule2019-09-252026-08-01NoNoCurrent
69367-236-10693670236101000 CAPSULE in 1 BOTTLE (69367-236-10) 1000 capsule2019-09-252026-08-01NoNoCurrent