FDA.reportPublic FDA data

Fluoxetine

Product NDC
69367-235
11-digit product format
693670235
Labeler code
69367
Product ID
69367-235_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
10 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 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
69367-235-01Fluoxetine100 in 1 BOTTLECAPSULE1006
69367-235-10Fluoxetine1000 in 1 BOTTLECAPSULE10006

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69367-235-01EA - Each69367-235f5e2fbf1-b3b6-444a-8067-de6d9ebd77a212020-02-13
69367-235-10EA - Each69367-2356f00421f-e3b3-4f29-9964-5a289fdb25dd12020-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69367-235FLUOXETINE (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
310384FLUoxetine 10 MG Oral CapsulePSNc4eeae3d-ae56-4e7e-b07d-02851f12039f1
310384fluoxetine 10 MG Oral CapsuleSCDc4eeae3d-ae56-4e7e-b07d-02851f12039f1
310384fluoxetine 10 MG (as fluoxetine HCl 11.2 MG) Oral CapsuleSYc4eeae3d-ae56-4e7e-b07d-02851f12039f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69367-235-0169367023501100 CAPSULE in 1 BOTTLE (69367-235-01) 100 capsule2019-09-252026-08-01NoNoCurrent
69367-235-10693670235101000 CAPSULE in 1 BOTTLE (69367-235-10) 1000 capsule2019-09-252026-08-01NoNoCurrent