FDA.reportPublic FDA data

Fluoxetine

Product NDC
51138-094
11-digit product format
511380094
Labeler code
51138
Product ID
51138-094_28b1893e-46ea-406a-82bc-10435fcca4ef
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluoxetine Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Med-Health Pharma, LLC
Application
ANDA078619
Marketing category
ANDA
Marketing start
2011-01-15
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
51138-094-302019-11-13C16284748780-197449f38-c611-f6ea-e053-dbdaa90aa703These 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
51138-094-30Fluoxetine30 in 1 BOTTLECAPSULE304

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51138-094-30EA - Each51138-0946dda0e24-61fb-4f50-a9ea-7f8648c0e47b12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FLUOXETINE HYDROCHLORIDEACTIVE INGREDIENTI9W7N6B1KJFLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [MED-HEALTH PHARMA, LLC]4
FLUOXETINEACTIVE MOIETY01K63SUP8DFLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [MED-HEALTH PHARMA, LLC]4
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDFLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [MED-HEALTH PHARMA, LLC]4
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [MED-HEALTH PHARMA, LLC]4
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTFLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [MED-HEALTH PHARMA, LLC]4
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [MED-HEALTH PHARMA, LLC]4
GELATININACTIVE INGREDIENT2G86QN327LFLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [MED-HEALTH PHARMA, LLC]4
SHELLACINACTIVE INGREDIENT46N107B71OFLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [MED-HEALTH PHARMA, LLC]4
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [MED-HEALTH PHARMA, LLC]4
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JFLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [MED-HEALTH PHARMA, LLC]4
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJFLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [MED-HEALTH PHARMA, LLC]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPFLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [MED-HEALTH PHARMA, LLC]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51138-094FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [MED-HEALTH PHARMA, LLC]4Legacy NDC, 1 package rows20120329_62c47df4-2c71-437e-b142-bc193f6277f0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310384FLUoxetine 10 MG Oral CapsulePSN62c47df4-2c71-437e-b142-bc193f6277f04
310385FLUoxetine 20 MG Oral CapsulePSN62c47df4-2c71-437e-b142-bc193f6277f04
313989FLUoxetine 40 MG Oral CapsulePSN62c47df4-2c71-437e-b142-bc193f6277f04
310384fluoxetine 10 MG Oral CapsuleSCD62c47df4-2c71-437e-b142-bc193f6277f04
310385fluoxetine 20 MG Oral CapsuleSCD62c47df4-2c71-437e-b142-bc193f6277f04
313989fluoxetine 40 MG Oral CapsuleSCD62c47df4-2c71-437e-b142-bc193f6277f04
310384fluoxetine 10 MG (as fluoxetine HCl 11.2 MG) Oral CapsuleSY62c47df4-2c71-437e-b142-bc193f6277f04
310385fluoxetine 20 MG (as fluoxetine HCl 22.4 MG) Oral CapsuleSY62c47df4-2c71-437e-b142-bc193f6277f04
313989fluoxetine 40 MG (as fluoxetine HCl 44.8 MG) Oral CapsuleSY62c47df4-2c71-437e-b142-bc193f6277f04

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
51138-094-305113800943030 in 1 BOTTLEHistorical