Fluoxetine

Product NDC
67296-1568
11-digit product format
672961568
Labeler code
67296
Product ID
67296-1568_d61bfd43-0862-e23d-e053-2a95a90ac456
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluoxetine Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
RedPharm Drug, Inc.
Application
ANDA204597
Marketing category
ANDA
Marketing start
2015-03-16
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
2023-12-31
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
67296-1568-32024-01-30C16284748780-11030e365-035b-111a-e063-dadaa90a10e2fluoxetine 20mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67296-1568-3Fluoxetine30 in 1 BOTTLECAPSULE309

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67296-1568FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [REDPHARM DRUG, INC.]9Legacy NDC, 1 package rows20220122_602ac784-a7fe-e5f1-e053-2a91aa0ac50d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310385FLUoxetine 20 MG Oral CapsulePSN602ac784-a7fe-e5f1-e053-2a91aa0ac50d9
310385fluoxetine 20 MG Oral CapsuleSCD602ac784-a7fe-e5f1-e053-2a91aa0ac50d9
310385fluoxetine 20 MG (as fluoxetine HCl 22.4 MG) Oral CapsuleSY602ac784-a7fe-e5f1-e053-2a91aa0ac50d9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67296-1568-36729615680330 CAPSULE in 1 BOTTLE (67296-1568-3) 30 capsule2015-03-160000-00-00NoNoCurrent