FDA.reportPublic FDA data

NDC 0002-3231-33 - Symbyax

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
0002-3231
Requested NDC
0002-3231-33
Package NDCs from labels
0002-3231-30, 0002-3231-33
Manufacturer
Eli Lilly and Company
Effective date
2025-01-22
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Symbyax - Eli Lilly and CompanyEli Lilly and Company2025-01-22HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2012-07-24Indexing - Billing Unit

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0002-3231SYMBYAX (OLANZAPINE AND FLUOXETINE HYDROCHLORIDE) CAPSULE [ELI LILLY AND COMPANY]85Legacy NDC20250206_6b28c424-0b7e-4b75-b090-f116b113554e.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0002-3231-01EA - Each0002-323104457210-4faa-457a-b711-c193b845991a12012-07-24
0002-3231-30EA - Each0002-3231f50f1bc4-8654-4b6e-8fec-8cbc341ee2d412012-07-24
0002-3231-33EA - Each0002-323110333ebd-8f6a-4160-9774-d301293d514a12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Fluoxetine hydrochlorideACTIVE INGREDIENTI9W7N6B1KJSYMBYAX (OLANZAPINE AND FLUOXETINE HYDROCHLORIDE) CAPSULE [ELI LILLY AND COMPANY]59
OlanzapineACTIVE INGREDIENTN7U69T4SZRSYMBYAX (OLANZAPINE AND FLUOXETINE HYDROCHLORIDE) CAPSULE [ELI LILLY AND COMPANY]59
FluoxetineACTIVE MOIETY01K63SUP8DSYMBYAX (OLANZAPINE AND FLUOXETINE HYDROCHLORIDE) CAPSULE [ELI LILLY AND COMPANY]59
OlanzapineACTIVE MOIETYN7U69T4SZRSYMBYAX (OLANZAPINE AND FLUOXETINE HYDROCHLORIDE) CAPSULE [ELI LILLY AND COMPANY]59
DimethiconeINACTIVE INGREDIENT92RU3N3Y1OSYMBYAX (OLANZAPINE AND FLUOXETINE HYDROCHLORIDE) CAPSULE [ELI LILLY AND COMPANY]59
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675SYMBYAX (OLANZAPINE AND FLUOXETINE HYDROCHLORIDE) CAPSULE [ELI LILLY AND COMPANY]59
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTSYMBYAX (OLANZAPINE AND FLUOXETINE HYDROCHLORIDE) CAPSULE [ELI LILLY AND COMPANY]59
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357SYMBYAX (OLANZAPINE AND FLUOXETINE HYDROCHLORIDE) CAPSULE [ELI LILLY AND COMPANY]59
GelatinINACTIVE INGREDIENT2G86QN327LSYMBYAX (OLANZAPINE AND FLUOXETINE HYDROCHLORIDE) CAPSULE [ELI LILLY AND COMPANY]59
sodium lauryl sulfateINACTIVE INGREDIENT368GB5141JSYMBYAX (OLANZAPINE AND FLUOXETINE HYDROCHLORIDE) CAPSULE [ELI LILLY AND COMPANY]59
STARCH, CornINACTIVE INGREDIENTO8232NY3SJSYMBYAX (OLANZAPINE AND FLUOXETINE HYDROCHLORIDE) CAPSULE [ELI LILLY AND COMPANY]59
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPSYMBYAX (OLANZAPINE AND FLUOXETINE HYDROCHLORIDE) CAPSULE [ELI LILLY AND COMPANY]59

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 27 of 147 · 2,933 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CalamineFERRIC OXIDE REDTarget Corporationd4ee05c8-ae62-45df-8783-1ed57fa030ec2026-02-18Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
Hermes Plein Air-Baume de Teint Perfecteur Naturel-Enhancing Complexion Balm 85 TAMARINTITANIUM DIOXIDES.A. COMPTOIR NOUVEAU DE LA PARFUMERIEdacff3dc-49d7-6416-e053-2a95a90a85c62026-02-18WarningsExact identifier
unii: 15FIX9V2JP
OLANZAPINEOLANZAPINEEugia US LLC9c745e2e-89d3-44d4-906e-704705c333102026-02-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: N7U69T4SZR
FluoxetineFLUOXETINE HYDROCHLORIDEA-S Medication Solutions2c56a437-f6bf-4ac8-b1d9-fc8a605a97e72026-02-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: I9W7N6B1KJ
Daily MoisturizingDIMETHICONEValu Merchandisers Company0cccadd7-11f3-5d1f-e063-6294a90a55c42026-02-16Warnings, Adverse reactionsExact identifier
unii: 92RU3N3Y1O
CalamineFERRIC OXIDE REDTopco Associates LLC2b32e720-ac71-4d60-bc06-e28a00f8a4502026-02-13Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
CalamineCALAMINE, PRAMOXINE HCLTopco Associates LLC15d1ae3f-509c-4e6b-8f0c-cf92656803582026-02-13Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
DimethiconeDIMETHICONETopco Associates LLCf37f17f7-f084-4b74-8361-178d2315a4762026-02-13Warnings, Adverse reactionsExact identifier
unii: 92RU3N3Y1O
Daily MoisturizingDIMETHICONETopco Associates LLC47e54eee-70e0-4bfa-ae77-d61a6560a9e12026-02-13Warnings, Adverse reactionsExact identifier
unii: 92RU3N3Y1O
TEENY TUMMY Gas Relief DropsSIMETHICONEALTANTIC BIOLOGICAS CORP.05eadb73-4468-4dae-a67b-133d893feed22026-02-13WarningsExact identifier
unii: 92RU3N3Y1O
Gas ReliefSIMETHICONE 180 MGPioneer Life Sciences, LLCf5284b68-f167-41d4-8b2f-ae7bafae0f4c2026-02-13WarningsExact identifier
unii: 92RU3N3Y1O
FluoxetineFLUOXETINE HYDROCHLORIDEA-S Medication Solutions3e6b9d55-f9bb-4bf2-bc6c-975cc0d94d232026-02-12Boxed warning, Warnings, Adverse reactionsExact identifier
unii: I9W7N6B1KJ
FluoxetineFLUOXETINEChartwell Governmental & Specialty RX, LLCd34362ed-e821-4c55-9f8c-3dfb772b1b2a2026-02-11Boxed warning, Warnings, Adverse reactionsExact identifier
unii: I9W7N6B1KJ
OlanzapineOLANZAPINEAurobindo Pharma Limited636665be-9d7e-443a-8134-e8cc47e6ba242026-02-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: N7U69T4SZR
Alumier MD Clear Shield Broad Spectrum SPF 42 SunscreenTITANIUM DIOXIDE, ZINC OXIDEAlumier Labsa9c970c8-b6e3-b0a1-e053-2a95a90a89c72026-02-09WarningsExact identifier
unii: 15FIX9V2JP
Hampton Sun SPF 50 MineralZINC OXIDE 19.5% TITANIUM DIOXIDE 4.00%S&C Hampton Sun LLCd6c33436-042e-44e8-8b55-98be6e2468792026-02-06WarningsExact identifier
unii: 15FIX9V2JP
SHISEIDO WASO COLOR-SMART DAY MOISTURIZEROCTINOXATE, TITANIUM DIOXIDEShiseido Americas Corporationf291f077-1c72-48fc-bb19-c20bdeaaa5962026-02-06WarningsExact identifier
unii: 15FIX9V2JP
Daily MoisturizingDIMETHICONERetail Business Services, LLCc8a876e2-0a34-4c3d-a0bc-549dd3048e8a2026-02-06Warnings, Adverse reactionsExact identifier
unii: 92RU3N3Y1O
SHISEIDO WASO COLOR-SMART DAY MOISTURIZEROCTINOXATE, TITANIUM DIOXIDEShiseido Americas Corporation54f63dd8-e77f-42e4-a6d3-61ab7beecf502026-02-06WarningsExact identifier
unii: 15FIX9V2JP
SEYTU Body SunscreenTITANIUM DIOXIDE AND ZINC OXIDEOmnilife USA, Inc.c411e9a6-b2ea-446b-a886-b92c61736e6c2026-02-05WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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