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 9 of 149 · 2,970 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Alabaster Beige Perfecting Makeup Broad Spectrum SPF 25OCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc5519290c-b040-6a37-e063-6394a90a8a1d2026-06-25WarningsExact identifier
unii: 15FIX9V2JP
FluoxetineFLUOXETINE HYDROCHLORIDEREMEDYREPACK INC.20516384-6517-48be-bd6e-718250878a762026-06-25Boxed warning, Warnings, Adverse reactionsExact identifier
unii: I9W7N6B1KJ
Soft Bisque Perfecting Makeup Broad Spectrum SPF 25OCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc551ab7d1-dd2f-c6d8-e063-6394a90aff652026-06-25WarningsExact identifier
unii: 15FIX9V2JP
Alabaster Perfecting Makeup Broad Spectrum SPF 25OCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc551b8c21-3afc-c804-e063-6294a90a51562026-06-25WarningsExact identifier
unii: 15FIX9V2JP
Bare Perfecting Makeup Broad Spectrum SPF 25OCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc552f20b2-9a2e-70f3-e063-6394a90a93372026-06-25WarningsExact identifier
unii: 15FIX9V2JP
Gas Relief Extra StrengthSIMETHICONEDolgencorp, Inc. (DOLLAR GENERAL & REXALL)447ee411-f4b9-4dd1-a3e0-36ad79bccbf92026-06-25WarningsExact identifier
unii: 92RU3N3Y1O
CalaSootheCALAMINE, MENTHOL, AND ZINC OXIDEDynarex Corporation54f12005-acfe-4821-e063-6394a90ac3042026-06-24WarningsExact identifier
unii: 1K09F3G675
BROAD SPECTRUM SPF 50 UNIVERSAL TINTED SUNSCREENTITANIUM DIOXIDEShantou Woodsleep Biotechnology Co., Ltd.54fc80b7-8f6c-e2be-e063-6394a90a4b592026-06-24WarningsExact identifier
unii: 15FIX9V2JP
OlanzapineOLANZAPINEREMEDYREPACK INC.e830f488-c689-40f6-9351-f9c7454ff1ea2026-06-24Boxed warning, Warnings, Adverse reactionsExact identifier
unii: N7U69T4SZR
Cerave Developed with Dermatologists Hydrating Sunscreen SPF 30 Body Lightweight, non-greasy feel 3 essential ceramides Mineral SunscreenTITANIUM DIOXIDE AND ZINC OXIDEL'Oreal USA Products Inc54ecaea7-dafe-9694-e063-6394a90ae3b52026-06-23WarningsExact identifier
unii: 15FIX9V2JP
Comfort Shield BarrierDIMETHICONESage Products LLCcc08f571-84ae-4c2f-b09d-a83a8efc39f52026-06-23WarningsExact identifier
unii: 92RU3N3Y1O
Fluoxetine hydrochlorideFLUOXETINE HYDROCHLORIDEDr.Reddy's Laboratories Limited887fc670-db67-4cfe-967b-46b38375dae52026-06-22Boxed warning, Warnings, Adverse reactionsExact identifier
unii: I9W7N6B1KJ
RYDEEN UV CLEARSUNSCREENGuangzhou Oupeng Cosmetics Co., Ltd.548000cd-1655-aeb3-e063-6294a90ad0042026-06-22WarningsExact identifier
unii: 15FIX9V2JP
FluoxetineFLUOXETINEUnit Dose Solutions, Inc.54d9f02c-95ea-99b1-e063-6294a90a91402026-06-22Boxed warning, Warnings, Adverse reactionsExact identifier
unii: I9W7N6B1KJ
Good Instincts Proper Sunscreen SPF 50ZINC OXIDE, TITANIUM DIOXIDEInhabit Brands, Inc82d2af99-7c42-4ce5-94e0-b2ac60b8db1b2026-06-22WarningsExact identifier
unii: 15FIX9V2JP
ESPOIR BE VELVET COVER CUSHIONHOMOSALATE, TITANIUM DIOXIDEESPOIR Corporation54ce2420-4ac0-eb51-e063-6294a90a2de92026-06-21WarningsExact identifier
unii: 15FIX9V2JP
OlanzapineOLANZAPINERedpharm Drug54adae9e-6781-6a77-e063-6394a90ab5c82026-06-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: N7U69T4SZR
BABIES KIDSSUN PROTECTIONMINERAL SUNSCREENPANERGYTEK USA INC3a554118-b71d-a844-e063-6294a90a699f2026-06-20WarningsExact identifier
unii: 15FIX9V2JP
FluoxetineFLUOXETINE HYDROCHLORIDEBryant Ranch Prepack023cef65-c9c2-4d70-af66-198fb1b577142026-06-19Boxed warning, Warnings, Adverse reactionsExact identifier
unii: I9W7N6B1KJ
OlanzapineOLANZAPINECoupler LLC549dc142-adcd-99ed-e063-6294a90a37fa2026-06-19Boxed warning, Warnings, Adverse reactionsExact identifier
unii: N7U69T4SZR

Reported adverse events (FAERS/openFDA)#

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