FDA.reportPublic FDA data

FLUOXETINE

Product NDC
67046-214
11-digit product format
670460214
Labeler code
67046
Product ID
67046-214_592811f2-e230-6a58-e053-2991aa0a69a9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
FLUOXETINE
Dosage form
CAPSULE
Route
ORAL
Labeler
Contract Pharmacy Services-PA
Application
ANDA204597
Marketing category
ANDA
Marketing start
2015-07-30
Marketing end
0000-00-00
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
2020-12-31
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
67046-214-302022-01-28C16284748780-1d6a99b39-4e78-a426-e053-dadaa90af4c2These 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
67046-214-602022-01-28C16284748780-1d6a99b39-4e78-a426-e053-dadaa90af4c2These 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
67046-214-30FLUOXETINE30 in 1 BLISTER PACKCAPSULE301
67046-214-60FLUOXETINE60 in 1 BLISTER PACKCAPSULE601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67046-214FLUOXETINE CAPSULE [CONTRACT PHARMACY SERVICES-PA]1Legacy NDC, 2 package rows20170915_592811f2-e22f-6a58-e053-2991aa0a69a9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310385FLUoxetine 20 MG Oral CapsulePSN592811f2-e22f-6a58-e053-2991aa0a69a91
310385fluoxetine 20 MG Oral CapsuleSCD592811f2-e22f-6a58-e053-2991aa0a69a91
310385fluoxetine 20 MG (as fluoxetine HCl 22.4 MG) Oral CapsuleSY592811f2-e22f-6a58-e053-2991aa0a69a91

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67046-214-306704602143030 CAPSULE in 1 BLISTER PACK (67046-214-30) 30 capsule2017-09-140000-00-00NoNoCurrent
67046-214-606704602146060 CAPSULE in 1 BLISTER PACK (67046-214-60) 60 capsule2017-09-140000-00-00NoNoCurrent