FDA.reportPublic FDA data

Fluoxetine

Product NDC
53002-2305
11-digit product format
530022305
Labeler code
53002
Product ID
53002-2305_bf916850-d49d-4c39-8f65-e5f51da1e6e2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluoxetine
Dosage form
CAPSULE
Route
ORAL
Labeler
RPK Pharmaceuticals, Inc.
Application
ANDA076001
Marketing category
ANDA
Marketing start
2002-01-29
Marketing end
0000-00-00
Substance
FLUOXETINE HYDROCHLORIDE
Active strength
10 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
53002-2305-02025-01-30C16284748780-1f386c649-a06d-0266-e053-dadaa90a7c1aThese 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
53002-2305-12025-01-30C16284748780-1f386c649-a06d-0266-e053-dadaa90a7c1aThese 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
53002-2305-32025-01-30C16284748780-1f386c649-a06d-0266-e053-dadaa90a7c1aThese 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
53002-2305-62025-01-30C16284748780-1f386c649-a06d-0266-e053-dadaa90a7c1aThese 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
53002-2305-02023-06-08C16284748780-1f386c649-a06d-0266-e053-dadaa90a7c1aThese 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
53002-2305-12023-06-08C16284748780-1f386c649-a06d-0266-e053-dadaa90a7c1aThese 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
53002-2305-32023-06-08C16284748780-1f386c649-a06d-0266-e053-dadaa90a7c1aThese 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
53002-2305-62023-06-08C16284748780-1f386c649-a06d-0266-e053-dadaa90a7c1aThese 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
53002-2305-02023-01-30C16284748780-1f386c649-a06d-0266-e053-dadaa90a7c1aThese 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
53002-2305-12023-01-30C16284748780-1f386c649-a06d-0266-e053-dadaa90a7c1aThese 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
53002-2305-32023-01-30C16284748780-1f386c649-a06d-0266-e053-dadaa90a7c1aThese 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
53002-2305-62023-01-30C16284748780-1f386c649-a06d-0266-e053-dadaa90a7c1aThese 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
53002-2305-0Fluoxetine100 in 1 BOTTLECAPSULE1006
53002-2305-1Fluoxetine10 in 1 BOTTLECAPSULE106
53002-2305-3Fluoxetine30 in 1 BOTTLECAPSULE306
53002-2305-6Fluoxetine60 in 1 BOTTLECAPSULE606

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53002-2305FLUOXETINE CAPSULE [RPK PHARMACEUTICALS, INC.]6Legacy NDC, 4 package rows20230609_e75d342e-5119-4ffe-bb44-edec519df7a7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310384FLUoxetine 10 MG Oral CapsulePSNe75d342e-5119-4ffe-bb44-edec519df7a76
310384fluoxetine 10 MG Oral CapsuleSCDe75d342e-5119-4ffe-bb44-edec519df7a76
310384fluoxetine 10 MG (as fluoxetine HCl 11.2 MG) Oral CapsuleSYe75d342e-5119-4ffe-bb44-edec519df7a76

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53002-2305-053002230500100 CAPSULE in 1 BOTTLE (53002-2305-0) 100 capsule2019-01-010000-00-00NoNoCurrent
53002-2305-15300223050110 CAPSULE in 1 BOTTLE (53002-2305-1) 10 capsule2019-01-010000-00-00NoNoCurrent
53002-2305-35300223050330 CAPSULE in 1 BOTTLE (53002-2305-3) 30 capsule2019-01-010000-00-00NoNoCurrent
53002-2305-65300223050660 CAPSULE in 1 BOTTLE (53002-2305-6) 60 capsule2019-01-010000-00-00NoNoCurrent