FDA.reportPublic FDA data

FLUOXETINE

Product NDC
23155-028
11-digit product format
231550028
Labeler code
23155
Product ID
23155-028_320829b0-51bc-41aa-99e7-d5ff1375995c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
FLUOXETINE
Dosage form
CAPSULE
Route
ORAL
Labeler
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
Application
ANDA201336
Marketing category
ANDA
Marketing start
2024-10-13
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
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 HYDROCHLORIDE10 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
23155-028-01FLUOXETINE100 in 1 BOTTLECAPSULE10019
23155-028-10FLUOXETINE1000 in 1 BOTTLECAPSULE100019

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
23155-028-01EA - Each23155-028b1dc18cc-8808-4767-b347-0e04742edd7c12021-12-08
23155-028-10EA - Each23155-028fc020b14-89bd-47e1-9f18-204a5e37b8ad12021-12-08

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FLUOXETINE HYDROCHLORIDEACTIVE INGREDIENTI9W7N6B1KJFLUOXETINE CAPSULE [HERITAGE PHARMACEUTICALS INC.]8
FLUOXETINEACTIVE MOIETY01K63SUP8DFLUOXETINE CAPSULE [HERITAGE PHARMACEUTICALS INC.]8
ALCOHOLINACTIVE INGREDIENT3K9958V90MFLUOXETINE CAPSULE [HERITAGE PHARMACEUTICALS INC.]8
BUTYL ALCOHOLINACTIVE INGREDIENT8PJ61P6TS3FLUOXETINE CAPSULE [HERITAGE PHARMACEUTICALS INC.]8
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDFLUOXETINE CAPSULE [HERITAGE PHARMACEUTICALS INC.]8
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8FLUOXETINE CAPSULE [HERITAGE PHARMACEUTICALS INC.]8
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTFLUOXETINE CAPSULE [HERITAGE PHARMACEUTICALS INC.]8
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357FLUOXETINE CAPSULE [HERITAGE PHARMACEUTICALS INC.]8
GELATININACTIVE INGREDIENT2G86QN327LFLUOXETINE CAPSULE [HERITAGE PHARMACEUTICALS INC.]8
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302FLUOXETINE CAPSULE [HERITAGE PHARMACEUTICALS INC.]8
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30FLUOXETINE CAPSULE [HERITAGE PHARMACEUTICALS INC.]8
METHYL ALCOHOLINACTIVE INGREDIENTY4S76JWI15FLUOXETINE CAPSULE [HERITAGE PHARMACEUTICALS INC.]8
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3FLUOXETINE CAPSULE [HERITAGE PHARMACEUTICALS INC.]8
SHELLACINACTIVE INGREDIENT46N107B71OFLUOXETINE CAPSULE [HERITAGE PHARMACEUTICALS INC.]8
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJFLUOXETINE CAPSULE [HERITAGE PHARMACEUTICALS INC.]8
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPFLUOXETINE CAPSULE [HERITAGE PHARMACEUTICALS INC.]8
WATERINACTIVE INGREDIENT059QF0KO0RFLUOXETINE CAPSULE [HERITAGE PHARMACEUTICALS INC.]8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
23155-028FLUOXETINE CAPSULE [HERITAGE PHARMACEUTICALS INC. D/B/A AVET PHARMACEUTICALS INC.]19Current NDC, Legacy NDC, 2 package rows20241013_6f4e4e9f-9ded-452f-b3ef-ab6aa9c72952.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310384FLUoxetine 10 MG Oral CapsulePSN6f4e4e9f-9ded-452f-b3ef-ab6aa9c7295219
310385FLUoxetine 20 MG Oral CapsulePSN6f4e4e9f-9ded-452f-b3ef-ab6aa9c7295219
313989FLUoxetine 40 MG Oral CapsulePSN6f4e4e9f-9ded-452f-b3ef-ab6aa9c7295219
310384fluoxetine 10 MG Oral CapsuleSCD6f4e4e9f-9ded-452f-b3ef-ab6aa9c7295219
310385fluoxetine 20 MG Oral CapsuleSCD6f4e4e9f-9ded-452f-b3ef-ab6aa9c7295219
313989fluoxetine 40 MG Oral CapsuleSCD6f4e4e9f-9ded-452f-b3ef-ab6aa9c7295219
310384fluoxetine 10 MG (as fluoxetine HCl 11.2 MG) Oral CapsuleSY6f4e4e9f-9ded-452f-b3ef-ab6aa9c7295219
310385fluoxetine 20 MG (as fluoxetine HCl 22.4 MG) Oral CapsuleSY6f4e4e9f-9ded-452f-b3ef-ab6aa9c7295219
313989fluoxetine 40 MG (as fluoxetine HCl 44.8 MG) Oral CapsuleSY6f4e4e9f-9ded-452f-b3ef-ab6aa9c7295219

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
23155-028-0123155002801100 CAPSULE in 1 BOTTLE (23155-028-01) 100 capsule2024-10-130000-00-00NoNoCurrent
23155-028-10231550028101000 CAPSULE in 1 BOTTLE (23155-028-10) 1000 capsule2024-10-130000-00-00NoNoCurrent