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 7 of 149 · 2,970 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
fluoxetine hydrochlorideFLUOXETINE HYDROCHLORIDEBryant Ranch Prepackd5a267cb-08bd-4530-a7a8-2bceddd828e52026-07-13Boxed warning, Warnings, Adverse reactionsExact identifier
unii: I9W7N6B1KJ
fluoxetine hydrochlorideFLUOXETINE HYDROCHLORIDEBryant Ranch Prepack72e391aa-1a46-4589-8550-f83ac9241cf12026-07-13Boxed warning, Warnings, Adverse reactionsExact identifier
unii: I9W7N6B1KJ
OlanzapineOLANZAPINEREMEDYREPACK INC.3d69af75-7615-4ec2-b7ef-467b2558c5c82026-07-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: N7U69T4SZR
Gas ReliefSIMETHICONERite Aid Corporation43e94ffc-a3ec-4a16-98db-b000a6dc42302026-07-10WarningsExact identifier
unii: 92RU3N3Y1O
OlanzapineOLANZAPINEDr. Reddy's Laboratories Ltd.a4c525da-c2f6-b804-af49-6012959222542026-07-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: N7U69T4SZR
Drs. DIAPER RASH MAXIMUM STRENGTHZINC OXIDEOL PHARMA TECH, LLC Drs PHARMACY161ba174-1b13-83cd-e063-6394a90af19c2026-07-09WarningsExact identifier
unii: 92RU3N3Y1O
Bombee Honey Daily Glow Shield SunscreenHOMOSALATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDEABT ASIA Inc.56112dff-b091-7a56-e063-6294a90a77d32026-07-08WarningsExact identifier
unii: 15FIX9V2JP
OlanzapineOLANZAPINEREMEDYREPACK INC.ad350abc-a1fc-4be4-b2be-c629121552a02026-07-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: N7U69T4SZR
OlanzapineOLANZAPINEREMEDYREPACK INC.b513823d-927c-4111-8766-e6c37f84b2212026-07-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: N7U69T4SZR
OlanzapineOLANZAPINEREMEDYREPACK INC.68de2a51-69b2-4d99-be79-36a95a4bc4752026-07-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: N7U69T4SZR
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30DERMIO DERMATOLOGY LLC562f5b0d-6a10-305d-e063-6394a90a59802026-07-08WarningsExact identifier
unii: 15FIX9V2JP
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30Suzanne's Skin2soul LLC562fbaa6-f93a-5ec4-e063-6294a90a96342026-07-08WarningsExact identifier
unii: 15FIX9V2JP
OlanzapineOLANZAPINEMajor Pharmaceuticals0ecbf540-572e-4ca4-b694-18ca1cd1c1942026-07-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: N7U69T4SZR
OlanzapineOLANZAPINEREMEDYREPACK INC.1705bab2-a2f8-4534-b1fc-eb309cd2696b2026-07-07Boxed warning, Warnings, Adverse reactionsExact identifier
unii: N7U69T4SZR
Aussie Betta Tallow Sunscreen SPF50 SPF50TITANIUM DIOXIDE AND ZINC OXIDE SUNSCREENAUSSIE BETTA HEALTHY CARE PTY LTD56007d82-ff5b-6c26-e063-6294a90a09b62026-07-07WarningsExact identifier
unii: 15FIX9V2JP
EELHOE Body Coverage PerfectorTITANIUM DIOXIDEShantou Eelhoe Daily Chemical Technology Co., Ltd.5610c3b7-456b-3bc1-e063-6394a90a3fa82026-07-07WarningsExact identifier
unii: 15FIX9V2JP
Premier Tinted Mineral SunscreenBROAD SPECTRUM SPF30Emerald Aesthetics LLC55f88dd1-346c-22a5-e063-6294a90a711f2026-07-06WarningsExact identifier
unii: 15FIX9V2JP
Dr. Drop NMN Vital Balance (Drop No.1 Cream 90g)NMN (NICOTINAMIDE MONONUCLEOTIDE), ECTOIN (ECTOINE)Reedfresh Co., LTD55d703ca-ff9d-0dbc-e063-6294a90ab6b12026-07-05WarningsExact identifier
unii: 92RU3N3Y1O
FluoxetineFLUOXETINE HYDROCHLORIDEREMEDYREPACK INC.32afb28a-dc4c-4a7e-9701-1825f805e7df2026-07-03Boxed warning, Warnings, Adverse reactionsExact identifier
unii: I9W7N6B1KJ
OlanzapineOLANZAPINECamber Pharmaceuticals, Inc.c1387008-6dc4-4f1e-ae29-fa7a0f0be6842026-07-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: N7U69T4SZR

Reported adverse events (FAERS/openFDA)#

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