FDA.reportPublic FDA data

Fluoxetine

Product NDC
67046-213
11-digit product format
670460213
Labeler code
67046
Product ID
67046-213_7d663999-6c42-c066-e053-2a91aa0ab78a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluoxetine Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Contract Pharmacy Services-PA
Application
ANDA078619
Marketing category
ANDA
Marketing start
2017-09-19
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
67046-213-072022-01-28C16284748780-1d6a99b39-9df8-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 213 Initial U.S. Approval: 1987
67046-213-142022-01-28C16284748780-1d6a99b39-9df8-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 213 Initial U.S. Approval: 1987
67046-213-152022-01-28C16284748780-1d6a99b39-9df8-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 213 Initial U.S. Approval: 1987
67046-213-212022-01-28C16284748780-1d6a99b39-9df8-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 213 Initial U.S. Approval: 1987
67046-213-282022-01-28C16284748780-1d6a99b39-9df8-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 213 Initial U.S. Approval: 1987
67046-213-302022-01-28C16284748780-1d6a99b39-9df8-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 213 Initial U.S. Approval: 1987
67046-213-602022-01-28C16284748780-1d6a99b39-9df8-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 213 Initial U.S. Approval: 1987

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67046-213-07Fluoxetine7 in 1 BLISTER PACKCAPSULE72
67046-213-14Fluoxetine14 in 1 BLISTER PACKCAPSULE142
67046-213-15Fluoxetine15 in 1 BLISTER PACKCAPSULE152
67046-213-21Fluoxetine21 in 1 BLISTER PACKCAPSULE212
67046-213-28Fluoxetine28 in 1 BLISTER PACKCAPSULE282
67046-213-30Fluoxetine30 in 1 BLISTER PACKCAPSULE302
67046-213-60Fluoxetine60 in 1 BLISTER PACKCAPSULE602

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67046-213FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [CONTRACT PHARMACY SERVICES-PA]2Legacy NDC, 7 package rows20181220_598e9653-932d-3bfe-e053-2a91aa0afcbe.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310385FLUoxetine 20 MG Oral CapsulePSN598e9653-932d-3bfe-e053-2a91aa0afcbe2
310385fluoxetine 20 MG Oral CapsuleSCD598e9653-932d-3bfe-e053-2a91aa0afcbe2
310385fluoxetine 20 MG (as fluoxetine HCl 22.4 MG) Oral CapsuleSY598e9653-932d-3bfe-e053-2a91aa0afcbe2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67046-213-07670460213077 CAPSULE in 1 BLISTER PACK (67046-213-07) 7 capsule2017-09-190000-00-00NoNoCurrent
67046-213-146704602131414 CAPSULE in 1 BLISTER PACK (67046-213-14) 14 capsule2017-09-190000-00-00NoNoCurrent
67046-213-156704602131515 CAPSULE in 1 BLISTER PACK (67046-213-15) 15 capsule2017-09-190000-00-00NoNoCurrent
67046-213-216704602132121 CAPSULE in 1 BLISTER PACK (67046-213-21) 21 capsule2017-09-190000-00-00NoNoCurrent
67046-213-286704602132828 CAPSULE in 1 BLISTER PACK (67046-213-28) 28 capsule2017-09-190000-00-00NoNoCurrent
67046-213-306704602133030 CAPSULE in 1 BLISTER PACK (67046-213-30) 30 capsule2017-09-190000-00-00NoNoCurrent
67046-213-606704602136060 CAPSULE in 1 BLISTER PACK (67046-213-60) 60 capsule2017-09-190000-00-00NoNoCurrent