FDA.reportPublic FDA data

Fluoxetine

Product NDC
53002-1671
11-digit product format
530021671
Labeler code
53002
Product ID
53002-1671_3f2d36f0-0e45-4469-9206-08aa8c125f2d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluoxetine Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
RPK Pharmaceuticals, Inc.
Application
ANDA204597
Marketing category
ANDA
Marketing start
2015-03-16
Marketing end
0000-00-00
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
2021-12-31
Current FDA listing
Historical FDA.report record

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
53002-1671-02025-01-30C16284748780-19d75b9d0-6f64-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use fluoxetine capsules, USP safely and effectively. See full prescribing information for fluoxetine capsules, USP. FLUOXETINE capsules, USP for oral use Initial U.S. Approval: 1987
53002-1671-32025-01-30C16284748780-19d75b9d0-6f64-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use fluoxetine capsules, USP safely and effectively. See full prescribing information for fluoxetine capsules, USP. FLUOXETINE capsules, USP for oral use Initial U.S. Approval: 1987
53002-1671-02023-06-08C16284748780-19d75b9d0-6f64-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use fluoxetine capsules, USP safely and effectively. See full prescribing information for fluoxetine capsules, USP. FLUOXETINE capsules, USP for oral use Initial U.S. Approval: 1987
53002-1671-32023-06-08C16284748780-19d75b9d0-6f64-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use fluoxetine capsules, USP safely and effectively. See full prescribing information for fluoxetine capsules, USP. FLUOXETINE capsules, USP for oral use Initial U.S. Approval: 1987
53002-1671-02023-01-30C16284748780-19d75b9d0-6f64-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use fluoxetine capsules, USP safely and effectively. See full prescribing information for fluoxetine capsules, USP. FLUOXETINE capsules, USP for oral use Initial U.S. Approval: 1987
53002-1671-32023-01-30C16284748780-19d75b9d0-6f64-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use fluoxetine capsules, USP safely and effectively. See full prescribing information for fluoxetine capsules, USP. FLUOXETINE capsules, USP for oral use Initial U.S. Approval: 1987
53002-1671-02020-12-15C16284748780-19d75b9d0-6f64-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use fluoxetine capsules, USP safely and effectively. See full prescribing information for fluoxetine capsules, USP. FLUOXETINE capsules, USP for oral use Initial U.S. Approval: 1987
53002-1671-32020-12-15C16284748780-19d75b9d0-6f64-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use fluoxetine capsules, USP safely and effectively. See full prescribing information for fluoxetine capsules, USP. FLUOXETINE capsules, USP for oral use Initial U.S. Approval: 1987
53002-1671-02020-01-31C16284748780-19d75b9d0-6f64-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use fluoxetine capsules, USP safely and effectively. See full prescribing information for fluoxetine capsules, USP. FLUOXETINE capsules, USP for oral use Initial U.S. Approval: 1987
53002-1671-32020-01-31C16284748780-19d75b9d0-6f64-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use fluoxetine capsules, USP safely and effectively. See full prescribing information for fluoxetine capsules, USP. FLUOXETINE capsules, USP for oral use Initial U.S. Approval: 1987

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53002-1671-0Fluoxetine100 in 1 BOTTLECAPSULE1005
53002-1671-3Fluoxetine30 in 1 BOTTLECAPSULE305

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53002-1671FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [RPK PHARMACEUTICALS, INC.]5Legacy NDC, 2 package rows20230609_581fee7f-2c89-4815-8af7-9ee4ee4226f8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313989FLUoxetine 40 MG Oral CapsulePSN581fee7f-2c89-4815-8af7-9ee4ee4226f85
313989fluoxetine 40 MG Oral CapsuleSCD581fee7f-2c89-4815-8af7-9ee4ee4226f85
313989fluoxetine 40 MG (as fluoxetine HCl 44.8 MG) Oral CapsuleSY581fee7f-2c89-4815-8af7-9ee4ee4226f85

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53002-1671-053002167100100 CAPSULE in 1 BOTTLE (53002-1671-0) 100 capsule2017-09-010000-00-00NoNoCurrent
53002-1671-35300216710330 CAPSULE in 1 BOTTLE (53002-1671-3) 30 capsule2017-09-010000-00-00NoNoCurrent