FDA.reportPublic FDA data

NDC 0024-5869-01 - TOUJEO

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
0024-5869
Requested NDC
0024-5869-01
Package NDCs from labels
0024-5869-01, 0024-5869-03, 0024-5869-00
Manufacturer
Sanofi-Aventis U.S. LLC | Sanofi-Aventis Deutschland GmbH | Genzyme Corporation
Effective date
2025-05-30
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
TOUJEO - Sanofi-Aventis U.S. LLC | Sanofi-Aventis Deutschland GmbH | Genzyme CorporationSanofi-Aventis U.S. LLC | Sanofi-Aventis Deutschland GmbH | Genzyme Corporation2025-05-30HUMAN PRESCRIPTION DRUG LABEL
TOUJEO - A-S Medication SolutionsA-S Medication Solutions2023-04-27HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0024-5869-00TOUJEO1 in 1 CARTONINJECTION, SOLUTION125
0024-5869-00TOUJEO1.5 mL in 1 SYRINGEINJECTION, SOLUTION1.525
0024-5869-01TOUJEO1.5 mL in 1 SYRINGEINJECTION, SOLUTION1.525
0024-5869-03TOUJEO3 in 1 CARTONINJECTION, SOLUTION325

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0024-5869TOUJEO (INSULIN GLARGINE) INJECTION, SOLUTION TOUJEO MAX (INSULIN GLARGINE) INJECTION, SOLUTION [SANOFI-AVENTIS U.S. LLC]24Current NDC, Legacy NDC, 4 package rows20250319_c9561d96-124d-48ca-982f-0aa1575bff36.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0024-5869-00ML - Milliliter0024-586937c667e4-ce5b-4f9f-8bf7-b7ff3b00070c12021-06-02
0024-5869-01ML - Milliliter0024-586943f5217b-8e34-49dd-b0be-c1b2d5a05a9712017-11-06
0024-5869-03ML - Milliliter0024-5869ce96366d-7fde-4e4b-92ff-e6cdc6ac9ef712015-03-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
insulin glargineACTIVE INGREDIENT2ZM8CX04RZTOUJEO (INSULIN GLARGINE) INJECTION, SOLUTION [SANOFI-AVENTIS U.S. LLC]7
insulin glargineACTIVE MOIETY2ZM8CX04RZTOUJEO (INSULIN GLARGINE) INJECTION, SOLUTION [SANOFI-AVENTIS U.S. LLC]7
glycerinINACTIVE INGREDIENTPDC6A3C0OXTOUJEO (INSULIN GLARGINE) INJECTION, SOLUTION [SANOFI-AVENTIS U.S. LLC]7
metacresolINACTIVE INGREDIENTGGO4Y809LOTOUJEO (INSULIN GLARGINE) INJECTION, SOLUTION [SANOFI-AVENTIS U.S. LLC]7
waterINACTIVE INGREDIENT059QF0KO0RTOUJEO (INSULIN GLARGINE) INJECTION, SOLUTION [SANOFI-AVENTIS U.S. LLC]7
zincINACTIVE INGREDIENTJ41CSQ7QDSTOUJEO (INSULIN GLARGINE) INJECTION, SOLUTION [SANOFI-AVENTIS U.S. LLC]7

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 35 · 699 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Optimel Manuka Forte Eye GelGLYCERINMelcare Biomedical Pty Ltd8e0ed6e8-51fc-7c5b-e053-2a95a90a35a92026-03-11WarningsExact identifier
unii: PDC6A3C0OX
VARICO HPCALCAREA FLUORICA, CARBO VEGETABILIS, HAMAMELIS VIRGINIANA, LACHESIS MUTUS, LYCOPODIUM CLAVATUM, PULSATILLA (VULGARIS), SECALE CORNUTUM, STAPHYSAGRIA, ZINCUM METALLICUMBioActive Nutritional, Inc.4d5354a8-52cf-4ad9-b5f7-f9207b0a5cd42026-03-11WarningsExact identifier
unii: J41CSQ7QDS
Restless Leg Symptom ReliefARSENICUM ALBUM, BUFO RANA, CAUSTICUM, CHAMOMILLA, CROTALUS HORRIDUS, DIGITALIS PURPUREA, LACHESIS MUTUS, LILIUM TIGRINUM, PULSATILLA, RHUS TOX, SULPHUR, TARENTULA HISPANA, VISCUM ALBUM AND ZINCUM METALLICUM.King Bio Inc.07ab09eb-9430-4ea2-90c0-db2ca237cc962026-03-10WarningsExact identifier
unii: J41CSQ7QDS
FleetGLYCERINC.B. Fleet Company, Inc.31778652-e60e-4098-8e90-3e4f56b5800c2026-03-06WarningsExact identifier
unii: PDC6A3C0OX
GlycerinGLYCERINBeijing Jingfeng Pharmaceutical (Shandong) Co., Ltd4c6094b7-c1ef-26a3-e063-6394a90af4cc2026-03-06WarningsExact identifier
unii: PDC6A3C0OX
2-Pack Facial Serum2-PACK FACIAL SERUMGuangzhou Ariel Biotech Co., Ltd.27c7f645-cfb3-6db1-e063-6394a90a42ff2026-03-06WarningsExact identifier
unii: 059QF0KO0R
Artificial TearsGLYCERINPreferred Pharmaceuticals Inc.dd646c72-8f47-43c6-a734-db0dcc8cd4d12026-03-06WarningsExact identifier
unii: PDC6A3C0OX
Dry Eye Relief Sterile Lubricant Eye DropsGLYCERINSimilasan Corporation4c4cce1c-392e-354d-e063-6294a90a0ca32026-03-05WarningsExact identifier
unii: PDC6A3C0OX
Snore ControlBROMIUM, CHAMOMILLA, CINCHONA, CUPRUM METALLICUM, HELLEBORUS NIGER, HISTAMINUM HYDROCHLORICUM, HYDRASTIS CANADENSIS, KALI BICHROMICUM, LAUROCERASUS, NUX VOMICA, PHOSPHORICUM ACIDUM, RHUS TOX, SILICEA, STRAMONIUM, SULPHUR AND ZINCUM METALLICUM.King Bio Inc.704bb574-6c54-49d1-bdae-81ffe0e79d102026-03-04WarningsExact identifier
unii: J41CSQ7QDS
Arthritis Pain and Joint ReliefACTAEA SPICATA, AESCULUS HIPPOCASTANUM, ARNICA MONTANA, BELLIS PERENNIS, BRYONIA, CALCAREA CARBONICA, CALCAREA FLUORICA, CAUSTICUM, CIMICIFUGA RACEMOSA, FORMICUM ACIDUM, HYPERICUM PERFORATUM, LEDUM PALUSTRE, LITHIUM CARBONICUM, MAGNESIA PHOSPHORICA, PHOSPHORUS, PHYTOLACCA DECANDRA, PULSATILLA, RHODODENDRON CHRYSANTHUM, RHUS TOX, RUTA GRAVEOLENS, SALICYLICUM ACIDUM, SEPIA AND ZINCUM METALLICUM.King Bio Inc.8ecb7378-ea84-483c-ba1c-852d1ae7b90d2026-03-02WarningsExact identifier
unii: J41CSQ7QDS
Back, Muscle and Joint ReliefAESCULUS HIPPOCASTANUM, ARNICA MONTANA, BELLIS PERENNIS, BRYONIA, CALCAREA CARBONICA, CALCAREA FLUORICA, CIMICIFUGA RACEMOSA, COBALTUM METALLICUM, GNAPHALIUM POLYCEPHALUM, HYPERICUM PERFORATUM, KALI CARBONICUM, KALI PHOSPHORICUM, MAGNESIA PHOSPHORICA, OXALICUM ACIDUM, PHOSPHORUS, RHUS TOX, RUTA GRAVEOLENS, AND ZINCUM METALLICUM.King Bio Inc.c6e50f93-bc45-4755-8ab0-dbe0d9987fca2026-03-02WarningsExact identifier
unii: J41CSQ7QDS
Focus, Comprehension and LearningAGNUS CASTUS, AVENA SATIVA, BARYTA CARBONICA, CALCAREA CARBONICA, IGNATIA AMARA, LECITHIN, LYCOPODIUM CLAVATUM, NATRUM CARBONICUM, OLEANDER, PHOSPHORICUM ACIDUM, RNA AND ZINCUM METALLICUM.King Bio Inc.b2a4dd82-7dd4-4dff-8a03-770f524bce1f2026-03-02WarningsExact identifier
unii: J41CSQ7QDS
Restless LegsARSENICUM ALBUM, CAUSTICUM, CHAMOMILLA, LYCOPODIUM CLAVATUM, PALLADIUM METALLICUM, PLATINUM METALLICUM, ZINCUM METALLICUMNaturalCare1e245ee1-b76f-49ed-9403-9d91d0492ab92026-03-02WarningsExact identifier
unii: J41CSQ7QDS
Sore ThroatPHENOL GLYCERINCVS PHARMACY, INC9683bcfb-2f7e-48a4-aa79-500ee8df099a2026-03-02WarningsExact identifier
unii: PDC6A3C0OX
Refresh Optive Mega-3 PFCARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN, POLYSORBATE 80Allergan, Inc.326cb5d6-c784-404f-9a13-6d69262dda6e2026-03-01WarningsExact identifier
unii: PDC6A3C0OX
Dermatool HemorrhoidalGLYCERIN, LIDOCAINE, PETROLATUM, PHENYLEPHRINE HCLPapalo Group LLC4bc06f41-7733-ebd0-e063-6294a90af7a82026-02-26WarningsExact identifier
unii: PDC6A3C0OX
Mitochondria ProARALIA QUINQUEFOLIA, ARNICA MONTANA, ADENOSINUM TRIPHOSPHORICUM DINATRUM, ALPHA-KETOGLUTARICUM ACIDUM, ASCORBICUM ACIDUM, ALPHA-LIPOICUM ACIDUM, CALCAREA CARBONICA, CITRICUM ACIDUM, CUPRUM METALLICUM, CYSTEINUM, FERRUM METALLICUM, IODIUM, LEVOTHYROXINUM, MAGNESIUM GLUCONICUM DIHYDRICUM, MALICUM ACIDUM, MANGANUM ACETICUM, NADIDUM, NATRUM PYRUVICUM, NICOTINAMIDUM, PYRIDOXINUM HYDROCHLORICUM, RIBOFLAVINUM, SELENIUM METALLICUM, SULPHUR, THIAMINUM HYDROCHLORICUM, UBIDECARENONUM, ZINCUM METALLICUM,Energique, Inc.2f365207-b730-428d-9465-8853e86e79ff2026-02-18WarningsExact identifier
unii: J41CSQ7QDS
WowDay Hemorrhoid and Fissure CreamHEMORRHOID AND FISSURE CREAMWowDay LLC47ba86ad-240a-e733-e063-6394a90a24e32026-02-12WarningsExact identifier
unii: PDC6A3C0OX
Viva Hydration BoostGLYCERINNomax Inc174193b2-65eb-b5fd-e063-6394a90a9cd02026-02-10WarningsExact identifier
unii: PDC6A3C0OX
OptaseGLYCERINScope Health Inc376e0289-28e9-e87f-e063-6294a90a3b042026-01-30WarningsExact identifier
unii: PDC6A3C0OX

Reported adverse events (FAERS/openFDA)#

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