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 17 of 147 · 2,933 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OlanzapineOLANZAPINEGolden State Medical Supply, Inc.a1dfb4e7-4143-4422-b7a7-292e4fd750442026-04-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: N7U69T4SZR
FluoxetineFLUOXETINEREMEDYREPACK INC.d1c768b5-64bb-4036-aa92-797b3a5f92eb2026-04-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: I9W7N6B1KJ
Childrens Emetrol Multi Symptom Upset Stomach ReliefCHILDRENS EMETROL MULTI-SYMPTOM UPSET STOMACH RELIEFWellSpring Pharmaceutical Corporationfe9ccc29-3cca-4666-9bb5-abb41816b3f52026-04-23WarningsExact identifier
unii: 92RU3N3Y1O
Little Remedies Gas Relief DropsSIMTHICONEMedtech Products Inc.874d3f1d-1e4a-49ab-8285-4d6bf2601d5e2026-04-23WarningsExact identifier
unii: 92RU3N3Y1O
Johnsons Baby Mineral Sunscreen SPF 30TITANIUM DIOXIDE, ZINC OXIDEKenvue Brands LLC4fe04c4b-2751-0561-e063-6394a90af7682026-04-22WarningsExact identifier
unii: 15FIX9V2JP
Lazy Face SPF 30 FacescreenTITANIUM DIOXIDE, ZINC OXIDESunny Day Creations500ee303-7302-68d5-e063-6394a90ac6d42026-04-22WarningsExact identifier
unii: 15FIX9V2JP
FluoxetineFLUOXETINECoupler LLC50117d4f-0777-54d3-e063-6394a90a857c2026-04-22Boxed warning, Warnings, Adverse reactionsExact identifier
unii: I9W7N6B1KJ
Caldesene BabySTARCH, CORN AND ZINC OXIDEInsight Pharmaceuticals LLC9f12dee2-7afa-45e9-a729-0fd42bb777152026-04-22WarningsExact identifier
unii: O8232NY3SJ
Caldesene Medicated ProtectingCORNSTARCH AND ZINC OXIDEInsight Pharmaceuticals LLCffc92a0f-a7cf-4a46-b2f1-089df2bbb96b2026-04-22WarningsExact identifier
unii: O8232NY3SJ
FluoxetineFLUOXETINENorthwind Health Company, LLC50369762-c7c3-d58e-e063-6294a90af8df2026-04-21Boxed warning, Warnings, Adverse reactionsExact identifier
unii: I9W7N6B1KJ
CareOne Diarrhea and Gas ControlLOPERAMIDE HYDROCHLORIDE, SIMETHICONEAmerican Sales Companydfa3db5a-cef6-4ed5-b9f1-a20b6d1657b32026-04-21WarningsExact identifier
unii: 92RU3N3Y1O
good sense gas reliefSIMETHICONEPreferred Pharmaceuticals Inc.06836246-9058-42af-a8a3-5aec81f4b9cc2026-04-20WarningsExact identifier
unii: 92RU3N3Y1O
FluoxetineFLUOXETINE HYDROCHLORIDEPreferred Pharmaceuticals, Inc.ef0fa849-a3a0-45d2-9258-da2d46bee0892026-04-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: I9W7N6B1KJ
ELROEL Pang Pang Sun Cushion S7ZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATE, OCTISALATEMONOGLOT HOLDINGS Inc.256bf56f-aefa-47ce-890c-5a3896c11b922026-04-17WarningsExact identifier
unii: 15FIX9V2JP
JUNGSAEMMOOL Essential Skin Nuder Cushion FairTITANIUM DIOXIDE, OCTINOXATE, OCTISALATEJungsaemmool Beauty Co., Ltd.3a43c7c0-7468-4b7a-95b9-f03e37f1b49b2026-04-17WarningsExact identifier
unii: 15FIX9V2JP
JUNGSAEMMOOL Essential Skin Nuder Cushion Fair LightTITANIUM DIOXIDE, OCTINOXATE, OCTISALATEJungsaemmool Beauty Co., Ltd.a251eb20-02e6-4b55-b969-c1bef2f9d7322026-04-17WarningsExact identifier
unii: 15FIX9V2JP
JUNGSAEMMOOL Essential Skin Nuder Cushion Fair PinkTITANIUM DIOXIDE, OCTINOXATE, OCTISALATEJungsaemmool Beauty Co., Ltd.6684d69a-89ff-41e8-81f0-3e2367811a182026-04-17WarningsExact identifier
unii: 15FIX9V2JP
JUNGSAEMMOOL Essential Skin Nuder Cushion LightTITANIUM DIOXIDE, OCTINOXATE, OCTISALATEJungsaemmool Beauty Co., Ltd.bf24d081-85f7-4a26-9416-ecff1fe59dec2026-04-17WarningsExact identifier
unii: 15FIX9V2JP
JUNGSAEMMOOL Essential Skin Nuder Cushion Pink LightTITANIUM DIOXIDE, OCTINOXATE, OCTISALATEJungsaemmool Beauty Co., Ltd.4a09a01a-404f-4b67-91e0-666153f550e82026-04-17WarningsExact identifier
unii: 15FIX9V2JP
JUNGSAEMMOOL Essential Skin Nuder Cushion N-LightTITANIUM DIOXIDE, OCTINOXATE, OCTISALATEJungsaemmool Beauty Co., Ltd.cf7c4445-0382-47ab-aba9-b40d63e4f1cc2026-04-17WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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