Fluoxetine

Product NDC
42291-396
11-digit product format
422910396
Labeler code
42291
Product ID
42291-396_d57b14b4-16dc-2b6a-e053-2a95a90a3bd3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluoxetine
Dosage form
CAPSULE
Route
ORAL
Labeler
AvKARE
Application
ANDA076001
Marketing category
ANDA
Marketing start
2017-08-14
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
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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42291-396-01EA - Each42291-396f7d9da22-1a3d-47ca-ab1c-96b84f86022a12017-10-13
42291-396-10EA - Each42291-396da10c540-6016-4b8d-8a24-67c83d31376e12017-10-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42291-396FLUOXETINE CAPSULE [AVKARE]7Legacy NDC20240110_847edbf4-f40e-4493-ba74-aac21225eb99.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310384FLUoxetine 10 MG Oral CapsulePSNdc08d14f-4779-4f92-a9d3-2af1824906763
310384fluoxetine 10 MG Oral CapsuleSCDdc08d14f-4779-4f92-a9d3-2af1824906763
310384fluoxetine 10 MG (as fluoxetine HCl 11.2 MG) Oral CapsuleSYdc08d14f-4779-4f92-a9d3-2af1824906763

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42291-396-0142291039601100 CAPSULE in 1 BOTTLE (42291-396-01) 100 capsule2017-08-140000-00-00NoNoCurrent
42291-396-10422910396101000 CAPSULE in 1 BOTTLE (42291-396-10) 1000 capsule2017-08-140000-00-00NoNoCurrent