FDA.reportPublic FDA data

FLUOXETINE

Product NDC
31722-905
11-digit product format
317220905
Labeler code
31722
Product ID
31722-905_4ed2db42-7efb-4088-b709-b923901e349f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
FLUOXETINE
Dosage form
CAPSULE
Route
ORAL
Labeler
Camber Pharmaceuticals, Inc.
Application
ANDA204597
Marketing category
ANDA
Marketing start
2015-07-30
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
E
Listing certified through
2018-12-31
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
31722-905-012020-01-31C16284748780-19d75b9d0-da95-f424-e053-dadaa90a57ceThese 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
31722-905-052020-01-31C16284748780-19d75b9d0-da95-f424-e053-dadaa90a57ceThese 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
31722-905-302020-01-31C16284748780-19d75b9d0-da95-f424-e053-dadaa90a57ceThese 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
31722-905-01FLUOXETINE100 in 1 BOTTLECAPSULE1005
31722-905-05FLUOXETINE500 in 1 BOTTLECAPSULE5005
31722-905-30FLUOXETINE30 in 1 BOTTLECAPSULE305

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
31722-905FLUOXETINE CAPSULE [CAMBER PHARMACEUTICALS, INC.]5Legacy NDC, 3 package rows20170509_2a20b006-aad2-4cef-ac01-5acc557412c5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310384FLUoxetine 10 MG Oral CapsulePSN2a20b006-aad2-4cef-ac01-5acc557412c55
310385FLUoxetine 20 MG Oral CapsulePSN2a20b006-aad2-4cef-ac01-5acc557412c55
313989FLUoxetine 40 MG Oral CapsulePSN2a20b006-aad2-4cef-ac01-5acc557412c55
310384fluoxetine 10 MG Oral CapsuleSCD2a20b006-aad2-4cef-ac01-5acc557412c55
310385fluoxetine 20 MG Oral CapsuleSCD2a20b006-aad2-4cef-ac01-5acc557412c55
313989fluoxetine 40 MG Oral CapsuleSCD2a20b006-aad2-4cef-ac01-5acc557412c55
310384fluoxetine 10 MG (as fluoxetine HCl 11.2 MG) Oral CapsuleSY2a20b006-aad2-4cef-ac01-5acc557412c55
310385fluoxetine 20 MG (as fluoxetine HCl 22.4 MG) Oral CapsuleSY2a20b006-aad2-4cef-ac01-5acc557412c55
313989fluoxetine 40 MG (as fluoxetine HCl 44.8 MG) Oral CapsuleSY2a20b006-aad2-4cef-ac01-5acc557412c55

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
31722-905-0131722090501100 in 1 BOTTLEHistorical
31722-905-0531722090505500 in 1 BOTTLEHistorical
31722-905-303172209053030 in 1 BOTTLEHistorical