FDA.reportPublic FDA data

NDC 0093-7198-93 - Fluoxetine

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
0093-7198
Requested NDC
0093-7198-93
Package NDCs from labels
0093-7198-56, 0093-7198-01, 0093-7198-05, 0093-7198-93
Manufacturer
AvKARE
Effective date
2026-01-14
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Fluoxetine - AvKAREAvKARE2026-01-14HUMAN PRESCRIPTION DRUG LABEL
Fluoxetine - Teva Pharmaceuticals USA, Inc.Teva Pharmaceuticals USA, Inc.2025-09-30HUMAN PRESCRIPTION DRUG LABEL
Fluoxetine - Proficient Rx LPProficient Rx LP2024-10-01HUMAN PRESCRIPTION DRUG LABEL
Fluoxetine - REMEDYREPACK INC.REMEDYREPACK INC.2019-03-27HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2012-07-24Indexing - Billing Unit

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0093-7198-01Fluoxetine100 in 1 BOTTLECAPSULE10029
0093-7198-05Fluoxetine500 in 1 BOTTLECAPSULE50029
0093-7198-56Fluoxetine30 in 1 BOTTLECAPSULE3029

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0093-7198FLUOXETINE CAPSULE [TEVA PHARMACEUTICALS USA, INC.]27Current NDC, Legacy NDC, 3 package rows20240918_369dbfba-9de4-433c-8680-2ec047b8f8d9.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0093-7198-01EA - Each0093-7198abb95323-084f-4d8d-92fd-93530acaa00412012-07-24
0093-7198-05EA - Each0093-7198c7eaf276-3903-421b-87da-7a60f5ea842b12012-07-24
0093-7198-19EA - Each0093-7198030a99f1-3e81-40e4-9668-9daab5eee8ed12012-07-24
0093-7198-56EA - Each0093-71987a8b3a49-3f90-4487-88f1-e96e404e734412012-07-24
0093-7198-93EA - Each0093-7198f7a188f7-2171-42cb-93ea-efa431eb58bb12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FLUOXETINE HYDROCHLORIDEACTIVE INGREDIENTI9W7N6B1KJFLUOXETINE CAPSULE [TEVA PHARMACEUTICALS USA INC]13
FLUOXETINEACTIVE MOIETY01K63SUP8DFLUOXETINE CAPSULE [TEVA PHARMACEUTICALS USA INC]13
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933FLUOXETINE CAPSULE [TEVA PHARMACEUTICALS USA INC]13
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHFLUOXETINE CAPSULE [TEVA PHARMACEUTICALS USA INC]13
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GFLUOXETINE CAPSULE [TEVA PHARMACEUTICALS USA INC]13
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1OFLUOXETINE CAPSULE [TEVA PHARMACEUTICALS USA INC]13
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDFLUOXETINE CAPSULE [TEVA PHARMACEUTICALS USA INC]13
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKFLUOXETINE CAPSULE [TEVA PHARMACEUTICALS USA INC]13
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAFLUOXETINE CAPSULE [TEVA PHARMACEUTICALS USA INC]13
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357FLUOXETINE CAPSULE [TEVA PHARMACEUTICALS USA INC]13
GELATININACTIVE INGREDIENT2G86QN327LFLUOXETINE CAPSULE [TEVA PHARMACEUTICALS USA INC]13
INDIGOTINDISULFONATE SODIUMINACTIVE INGREDIENTD3741U8K7LFLUOXETINE CAPSULE [TEVA PHARMACEUTICALS USA INC]13
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3FLUOXETINE CAPSULE [TEVA PHARMACEUTICALS USA INC]13
SHELLACINACTIVE INGREDIENT46N107B71OFLUOXETINE CAPSULE [TEVA PHARMACEUTICALS USA INC]13
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4FLUOXETINE CAPSULE [TEVA PHARMACEUTICALS USA INC]13
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJFLUOXETINE CAPSULE [TEVA PHARMACEUTICALS USA INC]13
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPFLUOXETINE CAPSULE [TEVA PHARMACEUTICALS USA INC]13

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 2 of 175 · 3,500 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BMNP SiliceaSILICEATotal Operations Management LLC DBA:Bestmade Natural Products Micro5a58454f-aed6-24ba-e063-6294a90a47fb2026-08-31WarningsExact identifier
unii: ETJ7Z6XBU4
FluoxetineFLUOXETINE HYDROCHLORIDEMajor Pharmaceuticals76b264ce-2a13-4511-8e21-4ffad0a327f92026-08-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: I9W7N6B1KJ
Infants Gas Relief Dye FreeSIMETHICONE ANTIGASTHE KROGER CO.722c8226-6556-4150-9fda-91be2b31183f2026-08-31WarningsExact identifier
unii: 92RU3N3Y1O
Daily MoisturizingDIMETHICONEYour Military Exchangese7af5488-1c49-41e9-9d8b-d519c61076992026-08-28Warnings, Adverse reactionsExact identifier
unii: 92RU3N3Y1O
GERI-LANTA MAXIMUM STRENGTHALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONEPreferred Pharmaceuticals Inc.3b049027-30ac-4c78-a4f1-8191f7ed45bf2026-08-27WarningsExact identifier
unii: 92RU3N3Y1O
MedlineDIMETHICONEMedline Industries, LP0d964138-f68d-dbf5-e063-6294a90a83202026-08-27WarningsExact identifier
unii: 92RU3N3Y1O
MZANK SUNSCREEN DAILY ULTIMATE PROTECTION SPF50SUNSCREEN SPF50Guangzhou Meixi Biotechnology Co., Ltd.5a0b4bd2-f6ad-35dc-e063-6294a90a8a662026-08-27WarningsExact identifier
unii: 15FIX9V2JP
Extra Strength Gas ReliefSIMETHICONEShield Pharmaceuticals Corp534144be-fcaf-400d-b772-595c62ae6ea62026-08-27WarningsExact identifier
unii: 92RU3N3Y1O
AntacidALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONEGuardian Drug Company48ec50ab-f24b-367b-e063-6294a90ad7362026-08-27WarningsExact identifier
unii: 92RU3N3Y1O
anti diarrheal and anti gasLOPERAMIDE HYDROCHLORIDE, SIMETHICONECVS Pharmacy065699b5-217e-432f-a253-cea2d3f622332026-08-26WarningsExact identifier
unii: 92RU3N3Y1O
MELAO Hydrating Lightweight SunscreenAVOBENZONE,ENSULIZOLE,HOMOSALATE,OCTISALATE,OCTOCRYLENE,TITANIUM DIOXIDEGuangdong Aimu Biological Technology Co., Ltd59eeaea1-d726-99f3-e063-6394a90aeea32026-08-26WarningsExact identifier
unii: 15FIX9V2JP
REGULAR STRENGTH ANTACIDALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONEKROGER COMPANYb9e61a03-e008-50ab-e053-2a95a90a32102026-08-26WarningsExact identifier
unii: 92RU3N3Y1O
MAXIMUM STRENGTH ANTACIDALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONECVS PHARMACYaf71e02d-e7c7-f925-e053-2995a90a08612026-08-26WarningsExact identifier
unii: 92RU3N3Y1O
Argentum QuartzARGENTUM QUARTZUriel Pharmacy Inc.765c8c8f-0727-45da-a77e-c3907a3d07932026-08-26WarningsExact identifier
unii: ETJ7Z6XBU4
Endometrium ArgentumENDOMETRIUM ARGENTUMUriel Pharmacy Incd2d1428a-c8b5-9529-e053-2995a90a23432026-08-26WarningsExact identifier
unii: ETJ7Z6XBU4
S12 AIRBORNEALFALFA, ALLIUM SATIVUM, ARSENICUM IODATUM, BARLEY, BETULA PUBESCENS, BROWN RICE, CORN GRAIN, EUPHRASIA OFFICINALIS, FEATHER MIX, HAIR MIX, HISTAMINUM, HOUSE DUST MITE, LOLIUM PERENNE, OAT, PERFOLIATE HONEYSUCKLE, PHLEUM PRATENSE, POLLEN MIX, RYE, SABADILLA, SILICEA, SKIN MIX, SOLIDAGO VIRGAUREA, TARAXACUM OFFICINALE, TEREBINTHINA, WHEATApex Energetics Inc.bb0036c3-1e4d-5750-e053-2995a90ae8952026-08-26WarningsExact identifier
unii: ETJ7Z6XBU4
AntacidALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONEPreferred Pharmaceuticals Inc.a96496ff-4b35-4ebe-a6e4-bcfa48fb13412026-08-26WarningsExact identifier
unii: 92RU3N3Y1O
IMODIUM Multi-Symptom ReliefLOPERAMIDE HYDROCHLORIDE AND DIMETHICONEKenvue Brands LLCecb91e47-2b0c-47c8-9256-4623d8bc825e2026-08-25WarningsExact identifier
unii: 92RU3N3Y1O
Q Skin ScienceSUNSCREENInternational Cosmeceuticals, Inc59e4c3d0-ee4c-2350-e063-6394a90ac9d22026-08-25WarningsExact identifier
unii: 15FIX9V2JP
Gas ReliefSIMETHICONERugby Laboratories9353633b-5718-4366-a943-d49b8076256c2026-08-24WarningsExact identifier
unii: 92RU3N3Y1O

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.