FDA.reportPublic FDA data

Fluoxetine

Product NDC
53217-155
11-digit product format
532170155
Labeler code
53217
Product ID
53217-155_64fce738-5e92-446c-862a-46d0b3700e99
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluoxetine
Dosage form
CAPSULE
Route
ORAL
Labeler
Aidarex Pharmaceuticals LLC
Application
ANDA076001
Marketing category
ANDA
Marketing start
2002-01-29
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
2019-12-31
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
53217-155-302020-01-31C16284748780-19d75b9d0-81af-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
53217-155-602020-01-31C16284748780-19d75b9d0-81af-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
53217-155-902020-01-31C16284748780-19d75b9d0-81af-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
53217-155-30Fluoxetine30 in 1 BOTTLECAPSULE301
53217-155-60Fluoxetine60 in 1 BOTTLECAPSULE601
53217-155-90Fluoxetine90 in 1 BOTTLECAPSULE901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
53217-155-30EA - Each53217-1552e0770f0-fd1e-467b-8e70-13023ebf2cec12017-03-06
53217-155-60EA - Each53217-1559e2a00ec-e674-48ee-a9f0-a04c4c907cb612017-03-06
53217-155-90EA - Each53217-155b8eb2f40-578e-46a8-91d3-e407c8408e4c12017-03-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53217-155FLUOXETINE CAPSULE [AIDAREX PHARMACEUTICALS LLC]1Legacy NDC, 3 package rows20170218_a1269692-662f-4a11-87ed-3d42d1895d78.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310385FLUoxetine 20 MG Oral CapsulePSNa1269692-662f-4a11-87ed-3d42d1895d781
310385fluoxetine 20 MG Oral CapsuleSCDa1269692-662f-4a11-87ed-3d42d1895d781
310385fluoxetine 20 MG (as fluoxetine HCl 22.4 MG) Oral CapsuleSYa1269692-662f-4a11-87ed-3d42d1895d781

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
53217-155-305321701553030 in 1 BOTTLEHistorical
53217-155-605321701556060 in 1 BOTTLEHistorical
53217-155-905321701559090 in 1 BOTTLEHistorical