FDA.reportPublic FDA data

Fluoxetine

Product NDC
50228-115
11-digit product format
502280115
Labeler code
50228
Product ID
50228-115_46055a53-5131-73e6-e063-6394a90ac1db
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluoxetine Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
ScieGen Pharmaceuticals, Inc.
Application
ANDA204597
Marketing category
ANDA
Marketing start
2015-03-16
Substance
FLUOXETINE HYDROCHLORIDE
Active strength
40 mg/1
Pharmacologic classes
Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Fluoxetine
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FLUOXETINE HYDROCHLORIDE40 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiI9W7N6B1KJ
Rxcui310384, 310385, 313989

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50228-115-01Fluoxetine100 in 1 BOTTLECAPSULE10015
50228-115-05Fluoxetine500 in 1 BOTTLECAPSULE50015
50228-115-30Fluoxetine30 in 1 BOTTLECAPSULE3015

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50228-115-01EA - Each50228-1158b0bd42a-9d1b-46ba-a223-8707370b888412019-07-02
50228-115-05EA - Each50228-115a669bcb5-22ac-4f6c-a962-7ad75db8b06612019-05-02
50228-115-30EA - Each50228-11599c30cbf-b73b-48d7-ad24-80b99559278612019-05-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FLUOXETINE HYDROCHLORIDEACTIVE INGREDIENTI9W7N6B1KJFLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [SCIEGEN PHARMACEUTICALS, INC.]2
FLUOXETINEACTIVE MOIETY01K63SUP8DFLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [SCIEGEN PHARMACEUTICALS, INC.]2
AMMONIAINACTIVE INGREDIENT5138Q19F1XFLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [SCIEGEN PHARMACEUTICALS, INC.]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GFLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [SCIEGEN PHARMACEUTICALS, INC.]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDFLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [SCIEGEN PHARMACEUTICALS, INC.]2
FD&C RED NO. 3INACTIVE INGREDIENTPN2ZH5LOQYFLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [SCIEGEN PHARMACEUTICALS, INC.]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [SCIEGEN PHARMACEUTICALS, INC.]2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [SCIEGEN PHARMACEUTICALS, INC.]2
GELATININACTIVE INGREDIENT2G86QN327LFLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [SCIEGEN PHARMACEUTICALS, INC.]2
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TFLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [SCIEGEN PHARMACEUTICALS, INC.]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [SCIEGEN PHARMACEUTICALS, INC.]2
SHELLACINACTIVE INGREDIENT46N107B71OFLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [SCIEGEN PHARMACEUTICALS, INC.]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [SCIEGEN PHARMACEUTICALS, INC.]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JFLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [SCIEGEN PHARMACEUTICALS, INC.]2
STARCH, PREGELATINIZED CORNINACTIVE INGREDIENTO8232NY3SJFLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [SCIEGEN PHARMACEUTICALS, INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPFLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [SCIEGEN PHARMACEUTICALS, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50228-115FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [SCIEGEN PHARMACEUTICALS, INC.]14Current NDC, Legacy NDC, 3 package rows20240616_23899405-007b-48d9-82a9-a530b8e90784.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313989FLUoxetine 40 MG Oral CapsulePSN77d5c10a-0cfc-4b89-942c-0fb5c67ae409103
313989fluoxetine 40 MG Oral CapsuleSCD77d5c10a-0cfc-4b89-942c-0fb5c67ae409103
313989fluoxetine 40 MG (as fluoxetine HCl 44.8 MG) Oral CapsuleSY77d5c10a-0cfc-4b89-942c-0fb5c67ae409103
310384FLUoxetine 10 MG Oral CapsulePSN23899405-007b-48d9-82a9-a530b8e9078415
310385FLUoxetine 20 MG Oral CapsulePSN23899405-007b-48d9-82a9-a530b8e9078415
313989FLUoxetine 40 MG Oral CapsulePSN23899405-007b-48d9-82a9-a530b8e9078415
310384fluoxetine 10 MG Oral CapsuleSCD23899405-007b-48d9-82a9-a530b8e9078415
310385fluoxetine 20 MG Oral CapsuleSCD23899405-007b-48d9-82a9-a530b8e9078415
313989fluoxetine 40 MG Oral CapsuleSCD23899405-007b-48d9-82a9-a530b8e9078415
310384fluoxetine 10 MG (as fluoxetine HCl 11.2 MG) Oral CapsuleSY23899405-007b-48d9-82a9-a530b8e9078415
310385fluoxetine 20 MG (as fluoxetine HCl 22.4 MG) Oral CapsuleSY23899405-007b-48d9-82a9-a530b8e9078415
313989fluoxetine 40 MG (as fluoxetine HCl 44.8 MG) Oral CapsuleSY23899405-007b-48d9-82a9-a530b8e9078415
313989FLUoxetine 40 MG Oral CapsulePSNd121146e-7439-4169-a421-dab7b882b8aa8
313989FLUoxetine 40 MG Oral CapsulePSN2c56a437-f6bf-4ac8-b1d9-fc8a605a97e78
313989fluoxetine 40 MG Oral CapsuleSCD2c56a437-f6bf-4ac8-b1d9-fc8a605a97e78
313989fluoxetine 40 MG Oral CapsuleSCDd121146e-7439-4169-a421-dab7b882b8aa8
313989fluoxetine 40 MG (as fluoxetine HCl 44.8 MG) Oral CapsuleSYd121146e-7439-4169-a421-dab7b882b8aa8
313989fluoxetine 40 MG (as fluoxetine HCl 44.8 MG) Oral CapsuleSY2c56a437-f6bf-4ac8-b1d9-fc8a605a97e78
313989FLUoxetine 40 MG Oral CapsulePSNec608267-9c00-4d5c-a9ed-d89503f93d287
313989fluoxetine 40 MG Oral CapsuleSCDec608267-9c00-4d5c-a9ed-d89503f93d287
313989fluoxetine 40 MG (as fluoxetine HCl 44.8 MG) Oral CapsuleSYec608267-9c00-4d5c-a9ed-d89503f93d287
313989FLUoxetine 40 MG Oral CapsulePSN023cef65-c9c2-4d70-af66-198fb1b577146
313989fluoxetine 40 MG Oral CapsuleSCD023cef65-c9c2-4d70-af66-198fb1b577146
313989fluoxetine 40 MG (as fluoxetine HCl 44.8 MG) Oral CapsuleSY023cef65-c9c2-4d70-af66-198fb1b577146
313989FLUoxetine 40 MG Oral CapsulePSN3e6b9d55-f9bb-4bf2-bc6c-975cc0d94d234
313989fluoxetine 40 MG Oral CapsuleSCD3e6b9d55-f9bb-4bf2-bc6c-975cc0d94d234
313989fluoxetine 40 MG (as fluoxetine HCl 44.8 MG) Oral CapsuleSY3e6b9d55-f9bb-4bf2-bc6c-975cc0d94d234
313989FLUoxetine 40 MG Oral CapsulePSNbe4c5102-e0aa-3b89-e053-2a95a90a5d9d2
313989FLUoxetine 40 MG Oral CapsulePSN0259db51-e1ff-6e7a-e063-6394a90abace2
313989fluoxetine 40 MG Oral CapsuleSCD0259db51-e1ff-6e7a-e063-6394a90abace2
313989fluoxetine 40 MG Oral CapsuleSCDbe4c5102-e0aa-3b89-e053-2a95a90a5d9d2
313989fluoxetine 40 MG (as fluoxetine HCl 44.8 MG) Oral CapsuleSY0259db51-e1ff-6e7a-e063-6394a90abace2
313989fluoxetine 40 MG (as fluoxetine HCl 44.8 MG) Oral CapsuleSYbe4c5102-e0aa-3b89-e053-2a95a90a5d9d2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50228-115-0150228011501100 CAPSULE in 1 BOTTLE (50228-115-01) 100 capsule2015-03-160000-00-00NoNoCurrent
50228-115-0550228011505500 CAPSULE in 1 BOTTLE (50228-115-05) 500 capsule2015-03-160000-00-00NoNoCurrent
50228-115-305022801153030 CAPSULE in 1 BOTTLE (50228-115-30) 30 capsule2015-03-160000-00-00NoNoCurrent