FDA.reportPublic FDA data

Fluoxetine

Product NDC
21695-053
11-digit product format
216950053
Labeler code
21695
Product ID
21695-053_a1575590-4bdd-4f66-91fb-337e5f681747
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluoxetine Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Rebel Distributors Corp
Application
ANDA078619
Marketing category
ANDA
Marketing start
2008-01-31
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
21695-053-302019-09-24C16284748780-1934fe258-47d9-48b1-e053-8cdaa90a720aThese highlights do not include all the information needed to use fluoxetine safely and effectively. See full prescribing information for fluoxetine capsules. Fluoxetine Capsules, USP for Oral Use Initial U.S. Approval: 1987
21695-053-602019-09-24C16284748780-1934fe258-47d9-48b1-e053-8cdaa90a720aThese highlights do not include all the information needed to use fluoxetine safely and effectively. See full prescribing information for fluoxetine capsules. Fluoxetine Capsules, USP for Oral Use Initial U.S. Approval: 1987
21695-053-902019-09-24C16284748780-1934fe258-47d9-48b1-e053-8cdaa90a720aThese highlights do not include all the information needed to use fluoxetine safely and effectively. See full prescribing information for fluoxetine capsules. Fluoxetine Capsules, USP for Oral Use Initial U.S. Approval: 1987

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-053-30Fluoxetine30 in 1 BOTTLECAPSULE301
21695-053-60Fluoxetine60 in 1 BOTTLECAPSULE601
21695-053-90Fluoxetine90 in 1 BOTTLECAPSULE901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-053-30EA - Each21695-0531ea09f4e-93d9-41bf-bf9b-7d0ce36a8ee412012-07-24
21695-053-60EA - Each21695-053ca1bff6c-7a4f-4ac6-a12a-e8044db1f48a12012-07-24
21695-053-90EA - Each21695-0533d435278-4cef-49fa-bf94-dc0ffb8f59b512012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FLUOXETINE HYDROCHLORIDEACTIVE INGREDIENTI9W7N6B1KJFLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [REBEL DISTRIBUTORS CORP]1
FLUOXETINEACTIVE MOIETY01K63SUP8DFLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [REBEL DISTRIBUTORS CORP]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDFLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [REBEL DISTRIBUTORS CORP]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTFLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [REBEL DISTRIBUTORS CORP]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [REBEL DISTRIBUTORS CORP]1
GELATININACTIVE INGREDIENT2G86QN327LFLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [REBEL DISTRIBUTORS CORP]1
SHELLACINACTIVE INGREDIENT46N107B71OFLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [REBEL DISTRIBUTORS CORP]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [REBEL DISTRIBUTORS CORP]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JFLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [REBEL DISTRIBUTORS CORP]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJFLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [REBEL DISTRIBUTORS CORP]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPFLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-053FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [REBEL DISTRIBUTORS CORP]1Legacy NDC, 3 package rows20101119_a1575590-4bdd-4f66-91fb-337e5f681747.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310384FLUoxetine 10 MG Oral CapsulePSNa1575590-4bdd-4f66-91fb-337e5f6817471
310385FLUoxetine 20 MG Oral CapsulePSNa1575590-4bdd-4f66-91fb-337e5f6817471
310384fluoxetine 10 MG Oral CapsuleSCDa1575590-4bdd-4f66-91fb-337e5f6817471
310385fluoxetine 20 MG Oral CapsuleSCDa1575590-4bdd-4f66-91fb-337e5f6817471
310384fluoxetine 10 MG (as fluoxetine HCl 11.2 MG) Oral CapsuleSYa1575590-4bdd-4f66-91fb-337e5f6817471
310385fluoxetine 20 MG (as fluoxetine HCl 22.4 MG) Oral CapsuleSYa1575590-4bdd-4f66-91fb-337e5f6817471

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
21695-053-302169500533030 in 1 BOTTLEHistorical
21695-053-602169500536060 in 1 BOTTLEHistorical
21695-053-902169500539090 in 1 BOTTLEHistorical