FDA.reportPublic FDA data

Fluoxetine Hydrochloride

Product NDC
67544-848
11-digit product format
675440848
Labeler code
67544
Product ID
67544-848_b6d3beec-9ded-46ae-9122-462504bf2741
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluoxetine Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA075049
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
67544-848-302020-01-31C16284748780-19d75b9d0-46ae-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use FLUOXETINE CAPSULES USP safely and effectively. See full prescribing information for FLUOXETINE CAPSULES USP. FLUOXETINE capsules USP for oral use Initial U.S. Approval: 1987
67544-848-452020-01-31C16284748780-19d75b9d0-46ae-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use FLUOXETINE CAPSULES USP safely and effectively. See full prescribing information for FLUOXETINE CAPSULES USP. FLUOXETINE capsules USP for oral use Initial U.S. Approval: 1987
67544-848-532020-01-31C16284748780-19d75b9d0-46ae-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use FLUOXETINE CAPSULES USP safely and effectively. See full prescribing information for FLUOXETINE CAPSULES USP. FLUOXETINE capsules USP for oral use Initial U.S. Approval: 1987
67544-848-602020-01-31C16284748780-19d75b9d0-46ae-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use FLUOXETINE CAPSULES USP safely and effectively. See full prescribing information for FLUOXETINE CAPSULES USP. FLUOXETINE capsules USP for oral use Initial U.S. Approval: 1987
67544-848-702020-01-31C16284748780-19d75b9d0-46ae-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use FLUOXETINE CAPSULES USP safely and effectively. See full prescribing information for FLUOXETINE CAPSULES USP. FLUOXETINE capsules USP for oral use Initial U.S. Approval: 1987
67544-848-802020-01-31C16284748780-19d75b9d0-46ae-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use FLUOXETINE CAPSULES USP safely and effectively. See full prescribing information for FLUOXETINE CAPSULES USP. FLUOXETINE capsules USP for oral use Initial U.S. Approval: 1987
67544-848-922020-01-31C16284748780-19d75b9d0-46ae-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use FLUOXETINE CAPSULES USP safely and effectively. See full prescribing information for FLUOXETINE CAPSULES USP. FLUOXETINE capsules USP for oral use Initial U.S. Approval: 1987

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67544-848-30Fluoxetine Hydrochloride30 in 1 BOTTLE, PLASTICCAPSULE302
67544-848-45Fluoxetine Hydrochloride45 in 1 BOTTLE, PLASTICCAPSULE452
67544-848-53Fluoxetine Hydrochloride60 in 1 BOTTLE, PLASTICCAPSULE602
67544-848-60Fluoxetine Hydrochloride90 in 1 BOTTLE, PLASTICCAPSULE902
67544-848-70Fluoxetine Hydrochloride120 in 1 BOTTLE, PLASTICCAPSULE1202
67544-848-80Fluoxetine Hydrochloride180 in 1 BOTTLE, PLASTICCAPSULE1802
67544-848-92Fluoxetine Hydrochloride270 in 1 BOTTLE, PLASTICCAPSULE2702

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67544-848-30EA - Each67544-8480cba1bff-b659-4592-bcca-e903592df35b12014-08-01
67544-848-45EA - Each67544-848e7c9b8f2-6322-4dc7-ac93-e1b1800982c712014-08-01
67544-848-53EA - Each67544-848ad2bf3e1-2eb6-4fe1-a54d-6ab161fde84d12014-08-01
67544-848-60EA - Each67544-8487ba7c966-3f74-42e0-bbc3-79bd5d38bd4812014-08-01
67544-848-70EA - Each67544-8483ea83d85-ed27-41f3-8589-8823de70f63612014-08-01
67544-848-80EA - Each67544-8481d0675d5-42dc-4e82-8da4-98cd419362fb12014-08-01
67544-848-92EA - Each67544-848f1b5f9a9-b297-4623-9110-9b88960a86ee12014-08-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FLUOXETINE HYDROCHLORIDEACTIVE INGREDIENTI9W7N6B1KJFLUOXETINE HYDROCHLORIDE CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
FLUOXETINEACTIVE MOIETY01K63SUP8DFLUOXETINE HYDROCHLORIDE CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GFLUOXETINE HYDROCHLORIDE CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDFLUOXETINE HYDROCHLORIDE CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKFLUOXETINE HYDROCHLORIDE CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAFLUOXETINE HYDROCHLORIDE CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357FLUOXETINE HYDROCHLORIDE CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
GELATININACTIVE INGREDIENT2G86QN327LFLUOXETINE HYDROCHLORIDE CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30FLUOXETINE HYDROCHLORIDE CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3FLUOXETINE HYDROCHLORIDE CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4FLUOXETINE HYDROCHLORIDE CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JFLUOXETINE HYDROCHLORIDE CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJFLUOXETINE HYDROCHLORIDE CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPFLUOXETINE HYDROCHLORIDE CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67544-848FLUOXETINE HYDROCHLORIDE CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2Legacy NDC, 7 package rows20140708_2017acf4-ce16-4014-8105-31950f696e44.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310385FLUoxetine 20 MG Oral CapsulePSN2017acf4-ce16-4014-8105-31950f696e442
310385fluoxetine 20 MG Oral CapsuleSCD2017acf4-ce16-4014-8105-31950f696e442
310385fluoxetine 20 MG (as fluoxetine HCl 22.4 MG) Oral CapsuleSY2017acf4-ce16-4014-8105-31950f696e442

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
67544-848-306754408483030 in 1 BOTTLE, PLASTICHistorical
67544-848-456754408484545 in 1 BOTTLE, PLASTICHistorical
67544-848-536754408485360 in 1 BOTTLE, PLASTICHistorical
67544-848-606754408486090 in 1 BOTTLE, PLASTICHistorical
67544-848-7067544084870120 in 1 BOTTLE, PLASTICHistorical
67544-848-8067544084880180 in 1 BOTTLE, PLASTICHistorical
67544-848-9267544084892270 in 1 BOTTLE, PLASTICHistorical