FDA.reportPublic FDA data

Fluoxetine

Product NDC
71335-0924
11-digit product format
713350924
Labeler code
71335
Product ID
71335-0924_ffe74518-5a6e-4a92-ae3f-41fb7af9b642
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluoxetine
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA076001
Marketing category
ANDA
Marketing start
2002-01-29
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
Rxcui310385

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
71335-0924-12024-05-16C16284748780-11030e365-63cc-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
71335-0924-22024-05-16C16284748780-11030e365-63cc-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
71335-0924-32024-05-16C16284748780-11030e365-63cc-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
71335-0924-42024-05-16C16284748780-11030e365-63cc-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
71335-0924-52024-05-16C16284748780-11030e365-63cc-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
71335-0924-62024-05-16C16284748780-11030e365-63cc-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
71335-0924-72024-05-16C16284748780-11030e365-63cc-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
71335-0924-82024-05-16C16284748780-11030e365-63cc-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
71335-0924-92024-05-16C16284748780-11030e365-63cc-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
71335-0924-12024-01-30C16284748780-11030e365-63cc-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
71335-0924-22024-01-30C16284748780-11030e365-63cc-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
71335-0924-32024-01-30C16284748780-11030e365-63cc-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
71335-0924-42024-01-30C16284748780-11030e365-63cc-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
71335-0924-52024-01-30C16284748780-11030e365-63cc-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
71335-0924-62024-01-30C16284748780-11030e365-63cc-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
71335-0924-72024-01-30C16284748780-11030e365-63cc-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
71335-0924-82024-01-30C16284748780-11030e365-63cc-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
71335-0924-92024-01-30C16284748780-11030e365-63cc-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
71335-0924-1Fluoxetine30 in 1 BOTTLECAPSULE309
71335-0924-2Fluoxetine100 in 1 BOTTLECAPSULE1009
71335-0924-3Fluoxetine60 in 1 BOTTLECAPSULE609
71335-0924-4Fluoxetine15 in 1 BOTTLECAPSULE159
71335-0924-5Fluoxetine56 in 1 BOTTLECAPSULE569
71335-0924-6Fluoxetine28 in 1 BOTTLECAPSULE289
71335-0924-7Fluoxetine90 in 1 BOTTLECAPSULE909
71335-0924-8Fluoxetine120 in 1 BOTTLECAPSULE1209
71335-0924-9Fluoxetine45 in 1 BOTTLECAPSULE459

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-0924-1EA - Each71335-0924d000a512-3c12-43e0-ad07-a0b30627765412019-05-02
71335-0924-2EA - Each71335-09241b623bf3-f0f0-4ed0-be02-5fdc4008745c12023-12-05
71335-0924-3EA - Each71335-0924f2033007-1a25-487e-89ce-d27bc7cb59d012023-12-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0924FLUOXETINE CAPSULE [BRYANT RANCH PREPACK]9Current NDC, Legacy NDC, 9 package rows20240518_493a5946-e750-4500-afd1-8f3fdc1d420e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310385FLUoxetine 20 MG Oral CapsulePSN493a5946-e750-4500-afd1-8f3fdc1d420e9
310385fluoxetine 20 MG Oral CapsuleSCD493a5946-e750-4500-afd1-8f3fdc1d420e9
310385fluoxetine 20 MG (as fluoxetine HCl 22.4 MG) Oral CapsuleSY493a5946-e750-4500-afd1-8f3fdc1d420e9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-0924-17133509240130 CAPSULE in 1 BOTTLE (71335-0924-1) 30 capsule2018-08-310000-00-00NoNoCurrent
71335-0924-271335092402100 CAPSULE in 1 BOTTLE (71335-0924-2) 100 capsule2018-12-140000-00-00NoNoCurrent
71335-0924-37133509240360 CAPSULE in 1 BOTTLE (71335-0924-3) 60 capsule2019-04-050000-00-00NoNoCurrent
71335-0924-47133509240415 CAPSULE in 1 BOTTLE (71335-0924-4) 15 capsule2022-09-210000-00-00NoNoCurrent
71335-0924-57133509240556 CAPSULE in 1 BOTTLE (71335-0924-5) 56 capsule2022-09-210000-00-00NoNoCurrent
71335-0924-67133509240628 CAPSULE in 1 BOTTLE (71335-0924-6) 28 capsule2022-09-210000-00-00NoNoCurrent
71335-0924-77133509240790 CAPSULE in 1 BOTTLE (71335-0924-7) 90 capsule2018-09-050000-00-00NoNoCurrent
71335-0924-871335092408120 CAPSULE in 1 BOTTLE (71335-0924-8) 120 capsule2022-09-210000-00-00NoNoCurrent
71335-0924-97133509240945 CAPSULE in 1 BOTTLE (71335-0924-9) 45 capsule2022-09-210000-00-00NoNoCurrent