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 6 of 149 · 2,970 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FluoxetineFLUOXETINEREMEDYREPACK INC.24926986-7552-4f1a-8366-f035bbd071042026-07-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: I9W7N6B1KJ
Mederma Stretch Marks TherapyDIMETHICONEPMI Branded Pharmaceuticals, Inc.0f2918e3-9615-40e3-ab7e-6bfbe022e03c2026-07-16WarningsExact identifier
unii: 92RU3N3Y1O
fluoxetine hydrochlorideFLUOXETINE HYDROCHLORIDEBryant Ranch Prepackd4043133-38de-4faa-bb76-8fafa59138442026-07-16Boxed warning, Warnings, Adverse reactionsExact identifier
unii: I9W7N6B1KJ
Gelfos-MALUMINUM PHOSPHATE, COLLOIDAL, MAGNESIUM HYDROXIDE, SIMETHICONEMasaem Company56b9a769-08fb-738f-e063-6294a90a9eb22026-07-16WarningsExact identifier
unii: 92RU3N3Y1O
CalamineFERRIC OXIDE REDBetter Living Brands, LLCc7ef0ef3-6861-4b94-af4b-371fee8c1f3d2026-07-16Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
FEVIA Gas ControlSIMETHICONEVIVUNT PHARMA LLC4bd53a70-3ba0-364c-e063-6394a90a7a642026-07-16WarningsExact identifier
unii: 92RU3N3Y1O
FEVIA Gas ControlSIMETHICONEVIVUNT PHARMA LLC4b1d1bce-eeef-b790-e063-6294a90a166e2026-07-16WarningsExact identifier
unii: 92RU3N3Y1O
fluoxetine hydrochlorideFLUOXETINE HYDROCHLORIDEBryant Ranch Prepacka04a5bed-d051-4bb4-ae20-b09b10d5c1812026-07-16Boxed warning, Warnings, Adverse reactionsExact identifier
unii: I9W7N6B1KJ
FluoxetineFLUOXETINE HYDROCHLORIDEAmerican Health Packaging7bee936b-0130-4a6b-a974-956aef5486d92026-07-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: I9W7N6B1KJ
FluoxetineFLUOXETINEAmerican Health Packaging9965a672-7842-4926-9063-b76317c748622026-07-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: I9W7N6B1KJ
SimethiconeTARGET BERRY BLAST ANTACID HBG CHEWTarget5245af45-77c7-c95f-e063-6294a90a24f72026-07-15WarningsExact identifier
unii: 92RU3N3Y1O
Mederma PMDIMETHICONEPMI Branded Pharmaceuticals, Inc.26737285-f6ae-47eb-9019-33f1cfce30292026-07-15WarningsExact identifier
unii: 92RU3N3Y1O
FluoxetineFLUOXETINEAurobindo Pharma Limiteda9ed97dd-8041-4a02-889c-dcb8b2805f362026-07-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: I9W7N6B1KJ
FluoxetineFLUOXETINEAurobindo Pharma Limited09fb3100-1e06-4cdc-8016-7e4f5d0974902026-07-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: I9W7N6B1KJ
MEDERMA STRETCH MARKS THERAPYDIMETHICONEL. Perrigo Companye9366775-e85b-4403-a2c5-12d9fb3cc3fa2026-07-15WarningsExact identifier
unii: 92RU3N3Y1O
Remedy Barrier Cream Cloths Fragrance FreeDIMETHICONEMedline Industries, LP00e0cd4a-6049-408a-ab3f-9edf97e6438a2026-07-14WarningsExact identifier
unii: 92RU3N3Y1O
FLUOXETINE HYDROCHLORIDEFLUOXETINE HYDROCHLORIDESun Pharmaceutical Industries, Inc.77b6ae48-8e3a-42e6-9b5a-aeed750861e82026-07-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: I9W7N6B1KJ
Maximum Strength Antacid MintSIMETHICONEGuardian Drug Company48ec3132-17cf-1de9-e063-6294a90aa4072026-07-14WarningsExact identifier
unii: 92RU3N3Y1O
Gas ReliefSIMETHICONECARDINAL HEALTH 110, LLC. DBA LEADER 70000cce7f7db-99b8-4d7d-ac77-43da6323ebe12026-07-14WarningsExact identifier
unii: 92RU3N3Y1O
fluoxetine hydrochlorideFLUOXETINE HYDROCHLORIDEBryant Ranch Prepackfb0608d9-1ae3-43be-8a20-e9f34e9558622026-07-13Boxed warning, Warnings, Adverse reactionsExact identifier
unii: I9W7N6B1KJ

Reported adverse events (FAERS/openFDA)#

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