FDA.reportPublic FDA data

Fluoxetine

Product NDC
42254-235
11-digit product format
422540235
Labeler code
42254
Product ID
42254-235_7e82dcaa-fc75-4ea2-9465-5327e2747720
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluoxetine
Dosage form
CAPSULE
Route
ORAL
Labeler
Rebel Distributors Corp
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
E
Listing certified through
2017-12-31
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
42254-235-302019-09-24C16284748780-19350213a-3e12-c013-e053-90daa90a1393These highlights do not include all the information needed to use fluoxetine capsules USP safely and effectively. See full prescribing information for fluoxetine capsules USP. Initial U.S. Approval: 1987
42254-235-602019-09-24C16284748780-19350213a-3e12-c013-e053-90daa90a1393These highlights do not include all the information needed to use fluoxetine capsules USP safely and effectively. See full prescribing information for fluoxetine capsules USP. Initial U.S. Approval: 1987
42254-235-902019-09-24C16284748780-19350213a-3e12-c013-e053-90daa90a1393These highlights do not include all the information needed to use fluoxetine capsules USP safely and effectively. See full prescribing information for fluoxetine capsules USP. Initial U.S. Approval: 1987

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42254-235-30Fluoxetine30 in 1 BOTTLECAPSULE301
42254-235-60Fluoxetine60 in 1 BOTTLECAPSULE601
42254-235-90Fluoxetine90 in 1 BOTTLECAPSULE901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42254-235-30EA - Each42254-2355abc78e0-0a7c-458a-b7da-501023fd617d12013-03-03
42254-235-60EA - Each42254-235a39805b7-1cc6-4b76-bd23-f328f2e8e62712013-03-03
42254-235-90EA - Each42254-235f9e49d0a-815c-4fa7-9027-99f65dc353a112013-03-03

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42254-235FLUOXETINE CAPSULE [REBEL DISTRIBUTORS CORP]1Legacy NDC, 3 package rows20130221_7e82dcaa-fc75-4ea2-9465-5327e2747720.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310385FLUoxetine 20 MG Oral CapsulePSN7e82dcaa-fc75-4ea2-9465-5327e27477201
310385fluoxetine 20 MG Oral CapsuleSCD7e82dcaa-fc75-4ea2-9465-5327e27477201
310385fluoxetine 20 MG (as fluoxetine HCl 22.4 MG) Oral CapsuleSY7e82dcaa-fc75-4ea2-9465-5327e27477201

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
42254-235-304225402353030 in 1 BOTTLEHistorical
42254-235-604225402356060 in 1 BOTTLEHistorical
42254-235-904225402359090 in 1 BOTTLEHistorical