FDA.reportPublic FDA data

Fluoxetine

Product NDC
33261-184
11-digit product format
332610184
Labeler code
33261
Product ID
33261-184_cc89478b-92bc-405d-b618-06906a2e7359
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
10 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
33261-184-282020-01-31C16284748780-19d75b9d0-ae3a-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
33261-184-302020-01-31C16284748780-19d75b9d0-ae3a-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
33261-184-602020-01-31C16284748780-19d75b9d0-ae3a-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
33261-184-902020-01-31C16284748780-19d75b9d0-ae3a-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
33261-184-28Fluoxetine28 in 1 BOTTLE, PLASTICCAPSULE282
33261-184-30Fluoxetine30 in 1 BOTTLE, PLASTICCAPSULE302
33261-184-60Fluoxetine60 in 1 BOTTLE, PLASTICCAPSULE602
33261-184-90Fluoxetine90 in 1 BOTTLE, PLASTICCAPSULE902

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FLUOXETINE HYDROCHLORIDEACTIVE INGREDIENTI9W7N6B1KJFLUOXETINE CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
FLUOXETINEACTIVE MOIETY01K63SUP8DFLUOXETINE CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933FLUOXETINE CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
AMMONIAINACTIVE INGREDIENT5138Q19F1XFLUOXETINE CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GFLUOXETINE CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDFLUOXETINE CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
GELATININACTIVE INGREDIENT2G86QN327LFLUOXETINE CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30FLUOXETINE CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3FLUOXETINE CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
SHELLACINACTIVE INGREDIENT46N107B71OFLUOXETINE CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJFLUOXETINE CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPFLUOXETINE CAPSULE [AIDAREX PHARMACEUTICALS LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33261-184FLUOXETINE CAPSULE [AIDAREX PHARMACEUTICALS LLC]2Legacy NDC, 4 package rows20170223_53655048-40a3-45b2-9336-5616cfab68f0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310384FLUoxetine 10 MG Oral CapsulePSN53655048-40a3-45b2-9336-5616cfab68f02
310384fluoxetine 10 MG Oral CapsuleSCD53655048-40a3-45b2-9336-5616cfab68f02
310384fluoxetine 10 MG (as fluoxetine HCl 11.2 MG) Oral CapsuleSY53655048-40a3-45b2-9336-5616cfab68f02

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
33261-184-283326101842828 in 1 BOTTLE, PLASTICHistorical
33261-184-303326101843030 in 1 BOTTLE, PLASTICHistorical
33261-184-603326101846060 in 1 BOTTLE, PLASTICHistorical
33261-184-903326101849090 in 1 BOTTLE, PLASTICHistorical