FDA.reportPublic FDA data

Fluoxetine

Product NDC
71335-1145
11-digit product format
713351145
Labeler code
71335
Product ID
71335-1145_61f5ae93-5b8c-4c41-a3b1-cb5103056bf7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluoxetine Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
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
Rxcui313989

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71335-1145-12024-05-17C16284748780-11030e365-453b-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use FLUOXETINE CAPSULES safely and effectively. See full prescribing information for FLUOXETINE CAPSULES. FLUOXETINE capsules, for oral use Initial U.S. Approval: 1987
71335-1145-22024-05-17C16284748780-11030e365-453b-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use FLUOXETINE CAPSULES safely and effectively. See full prescribing information for FLUOXETINE CAPSULES. FLUOXETINE capsules, for oral use Initial U.S. Approval: 1987
71335-1145-32024-05-17C16284748780-11030e365-453b-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use FLUOXETINE CAPSULES safely and effectively. See full prescribing information for FLUOXETINE CAPSULES. FLUOXETINE capsules, for oral use Initial U.S. Approval: 1987
71335-1145-42024-05-17C16284748780-11030e365-453b-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use FLUOXETINE CAPSULES safely and effectively. See full prescribing information for FLUOXETINE CAPSULES. FLUOXETINE capsules, for oral use Initial U.S. Approval: 1987
71335-1145-52024-05-17C16284748780-11030e365-453b-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use FLUOXETINE CAPSULES safely and effectively. See full prescribing information for FLUOXETINE CAPSULES. FLUOXETINE capsules, for oral use Initial U.S. Approval: 1987
71335-1145-62024-05-17C16284748780-11030e365-453b-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use FLUOXETINE CAPSULES safely and effectively. See full prescribing information for FLUOXETINE CAPSULES. FLUOXETINE capsules, for oral use Initial U.S. Approval: 1987
71335-1145-72024-05-17C16284748780-11030e365-453b-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use FLUOXETINE CAPSULES safely and effectively. See full prescribing information for FLUOXETINE CAPSULES. FLUOXETINE capsules, for oral use Initial U.S. Approval: 1987
71335-1145-12024-01-30C16284748780-11030e365-453b-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use FLUOXETINE CAPSULES safely and effectively. See full prescribing information for FLUOXETINE CAPSULES. FLUOXETINE capsules, for oral use Initial U.S. Approval: 1987
71335-1145-22024-01-30C16284748780-11030e365-453b-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use FLUOXETINE CAPSULES safely and effectively. See full prescribing information for FLUOXETINE CAPSULES. FLUOXETINE capsules, for oral use Initial U.S. Approval: 1987
71335-1145-32024-01-30C16284748780-11030e365-453b-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use FLUOXETINE CAPSULES safely and effectively. See full prescribing information for FLUOXETINE CAPSULES. FLUOXETINE capsules, for oral use Initial U.S. Approval: 1987
71335-1145-42024-01-30C16284748780-11030e365-453b-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use FLUOXETINE CAPSULES safely and effectively. See full prescribing information for FLUOXETINE CAPSULES. FLUOXETINE capsules, for oral use Initial U.S. Approval: 1987
71335-1145-52024-01-30C16284748780-11030e365-453b-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use FLUOXETINE CAPSULES safely and effectively. See full prescribing information for FLUOXETINE CAPSULES. FLUOXETINE capsules, for oral use Initial U.S. Approval: 1987
71335-1145-62024-01-30C16284748780-11030e365-453b-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use FLUOXETINE CAPSULES safely and effectively. See full prescribing information for FLUOXETINE CAPSULES. FLUOXETINE capsules, for oral use Initial U.S. Approval: 1987
71335-1145-72024-01-30C16284748780-11030e365-453b-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use FLUOXETINE CAPSULES safely and effectively. See full prescribing information for FLUOXETINE CAPSULES. FLUOXETINE capsules, for oral use Initial U.S. Approval: 1987

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-1145-1Fluoxetine30 in 1 BOTTLECAPSULE305
71335-1145-2Fluoxetine60 in 1 BOTTLECAPSULE605
71335-1145-3Fluoxetine100 in 1 BOTTLECAPSULE1005
71335-1145-4Fluoxetine90 in 1 BOTTLECAPSULE905
71335-1145-5Fluoxetine28 in 1 BOTTLECAPSULE285
71335-1145-6Fluoxetine180 in 1 BOTTLECAPSULE1805
71335-1145-7Fluoxetine120 in 1 BOTTLECAPSULE1205

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1145FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [BRYANT RANCH PREPACK]5Current NDC, Legacy NDC, 7 package rows20240518_992060ee-fb4e-4c6d-9ffe-30902bc63af2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313989FLUoxetine 40 MG Oral CapsulePSN992060ee-fb4e-4c6d-9ffe-30902bc63af25
313989fluoxetine 40 MG Oral CapsuleSCD992060ee-fb4e-4c6d-9ffe-30902bc63af25
313989fluoxetine 40 MG (as fluoxetine HCl 44.8 MG) Oral CapsuleSY992060ee-fb4e-4c6d-9ffe-30902bc63af25

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1145-17133511450130 CAPSULE in 1 BOTTLE (71335-1145-1) 30 capsule2019-05-240000-00-00NoNoCurrent
71335-1145-27133511450260 CAPSULE in 1 BOTTLE (71335-1145-2) 60 capsule2024-05-170000-00-00NoNoCurrent
71335-1145-371335114503100 CAPSULE in 1 BOTTLE (71335-1145-3) 100 capsule2019-03-210000-00-00NoNoCurrent
71335-1145-47133511450490 CAPSULE in 1 BOTTLE (71335-1145-4) 90 capsule2019-03-120000-00-00NoNoCurrent
71335-1145-57133511450528 CAPSULE in 1 BOTTLE (71335-1145-5) 28 capsule2024-05-170000-00-00NoNoCurrent
71335-1145-671335114506180 CAPSULE in 1 BOTTLE (71335-1145-6) 180 capsule2024-05-170000-00-00NoNoCurrent
71335-1145-771335114507120 CAPSULE in 1 BOTTLE (71335-1145-7) 120 capsule2024-05-170000-00-00NoNoCurrent