FDA.reportPublic FDA data

NDC 0955-2900-01 - Insulin glargine U-300

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
0955-2900
Requested NDC
0955-2900-01
Package NDCs from labels
0955-2900-01, 0955-2900-02
Manufacturer
Sanofi-Aventis U.S. LLC | Genzyme Corporation | Sanofi-Aventis Deutschland GmbH
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
Insulin glargine U-300 - Sanofi-Aventis U.S. LLC | Genzyme Corporation | Sanofi-Aventis Deutschland GmbHSanofi-Aventis U.S. LLC | Genzyme Corporation | Sanofi-Aventis Deutschland GmbH2025-05-30HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0955-2900-01Insulin glargine U-300 Max3 mL in 1 SYRINGEINJECTION, SOLUTION37
0955-2900-02Insulin glargine U-300 Max2 in 1 CARTONINJECTION, SOLUTION27

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0955-2900INSULIN GLARGINE U-300 (INSULIN GLARGINE) INJECTION, SOLUTION INSULIN GLARGINE U-300 MAX (INSULIN GLARGINE) INJECTION, SOLUTION [WINTHROP U.S.]6Current NDC, 2 package rows20240913_99ea856d-9562-443a-9422-1006a3cff2f4.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0955-2900-01ML - Milliliter0955-2900d5f1116f-3b0d-4a22-b902-789dc1133f5512024-02-14
0955-2900-02ML - Milliliter0955-29006dda0158-cc5b-4530-884a-73ea65000a7e12024-02-14

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 33 of 36 · 718 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TOUJEOINSULIN GLARGINEA-S Medication Solutions257ca17b-6ff7-4f2e-9037-4c185bac57682023-04-27Warnings, Adverse reactionsExact identifier
application number: BLA206538
rxcui: 1604539
unii: 2ZM8CX04RZ
BHI Flu PlusACONITUM NAPELLUS, CAIRINA MOSCHATA HEART/LIVER AUTOLYSATE, BRYONIA ALBA WHOLE, EUPATORIUM PERFOLIATUM FLOWERING TOP, IPECAC, LACHESIS MUTA VENOM,PHOSPHORUS, PULSATILLA VULGARIS, SULFUR, ZINC GLUCONATE, AND ZINCMediNatura Inc8d73082d-a1bc-4e76-9714-49f718b5850b2023-04-13WarningsExact identifier
unii: J41CSQ7QDS
Sterile WaterWATERCivica, Inc.3f49eedf-5bf5-4a95-b704-c956d860ca042023-04-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
TreprostinilTREPROSTINILSandoz Inc473297ca-a872-4052-a053-87dc8f0d3c132023-04-06Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Virility LiquescenceAVENA SATIVA, DAMIANA, BERBERIS VULGARIS, EPIMEDIUM GRANDIFLORUM, GLYCERINUM, SABAL SERRULATA, IODIUM, LECITHIN, FERRUM MURIATICUM, NATRUM MURIATICUM, AGNUS CASTUS, BUFO RANA, CINCHONA OFFICINALIS, HUMAN GROWTH HORMONE (HGH), ORCHITINUM (BOVINE), PHOSPHORICUM ACIDUM, PHOSPHORUS, SELENIUM METALLICUM, ZINCUM VALERIANICUM, OOPHORINUM (SUIS), SEPIANutritional Specialties, Inc.81cc3e2b-f95e-4ba4-a15f-c07b4def0e2f2023-03-29WarningsExact identifier
unii: PDC6A3C0OX
Pancreas LiquescenceCINNAMOMUM, GYMNEMA SYLVESTRE, PHOSPHORICUM ACIDUM, SYZYGIUM JAMBOLANUM, TRIGONELLA FOENUM-GRACEUM, ARGENTUM NITRICUM, CHIONANTHUS VIRGINICA, HEPAR SUIS, PANCREAS SUIS, RHUS AROMATICA, SULPHUR, LYCOPODIUM CLAVATUM, CHROMIUM PICOLINATE, CHROMIUM METALLICUM, PHOSPHORUS, VANADIUM METALLICUM, ZINCUM METALLICUM, MUREX PURPUREA, DNA, INSULINUM (HUMAN), URANIUM NITRICUMNutritional Specialties, Inc.06300339-b068-4685-8475-3765f68288512023-03-27WarningsExact identifier
unii: J41CSQ7QDS
ZINCUM METALLICUMZINCBoiron857e92e8-3986-34b7-e053-2991aa0a72ba2023-03-27Exact identifier
unii: J41CSQ7QDS
Insulin Diluting Medium for NovoLogWATER INJECTIONNovo Nordisk3a1e73a2-3009-40d0-876c-b4cb2be56fc52023-02-28Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
LantusINSULIN GLARGINEA-S Medication Solutionsae27bb66-5dbe-4f01-a89e-f4fa7cb09c992023-02-04Warnings, Adverse reactionsExact identifier
unii: 2ZM8CX04RZ
ZINCUM METALLICUMZINCBoiron852f97b5-8da5-2e09-e053-2a91aa0a8bb42023-01-23Exact identifier
unii: J41CSQ7QDS
Acidum MuriaticumACIDUM MURIATICUMHahnemann Laboratories, INC.f2aad04c-5151-6cab-e053-2a95a90ad3a72023-01-19Exact identifier
unii: QTT17582CB
RehydrateAVENA SATIVA, EQUISETUM HYEMALE, HYPERICUM PERFORATUM, ULMUS FULVA, GLYCYRRHIZA GLABRA, SILICEA, PUERARIA LOBATA, CARLSBAD AQUA, ADENOSINUM TRIPHOSPHORICUM DINATRUM, GERMANIUM SESQUIOXIDE, HYDROGEN, OXYGEN, WIESBADENParaDocs All Natural, Inc.648fab10-c46b-420f-a42c-6642009d83fb2023-01-10WarningsExact identifier
unii: 059QF0KO0R
Immune SupportECHINACEA (ANGUSTIFOLIA), ARNICA MONTANA, BAPTISIA TINCTORIA, SANGUINARIA CANADENSIS, ARISTOLOCHIA CLEMATITIS, EUPATORIUM PERFOLIATUM, EUPHORBIUM OFFICINARUM, ACONITUM NAPELLUS, ARGENTUM NITRICUM, ARSENICUM ALBUM, BRYONIA (ALBA), GELSEMIUM SEMPERVIRENS, MERCURIUS CORROSIVUS, PHOSPHORUS, PHYTOLACCA DECANDRA, PULSATILLA (PRATENSIS), RHUS TOX, SULPHUR, THUJA OCCIDENTALIS, HEPAR SULPHURIS CALCAREUM, LACHESIS MUTUS, ZINCUM METALLICUM, ASTRAGALUS MEMBRANACEUS, INFLUENZINUM (2021-2022), SPLEEN (SUIS), THYMUS,Deseret Biologicals, Inc.3c6bb436-0b4f-4f0d-ba03-7963064a5b182022-12-29WarningsExact identifier
unii: J41CSQ7QDS
Zincum MetallicumZINCUM METALLICUMHahnemann Laboratories, INC.f03748db-9eff-ea3e-e053-2995a90aaaff2022-12-19Exact identifier
unii: J41CSQ7QDS
Whole System EepBELLADONNA, BERBER VULG, CAUSTICUM, CEANOTHUS, CHELIDONIUM MAJ, CINCHONA, COFFEA CRUDA, CONDURANGO, GRAPHITES, HYDRASTIS, IGNATIA, LILIUM, LYCOPODIUM, , MERC CORROS, NUX VOM, PANCREAS, SCROPHULARIA NODOSA, SENNA, SPONGIA, ZINC METWhite Manufacturing Inc. DBA Micro-Westccdee0bb-18cc-4180-ac4b-d9dc5c79895e2022-12-02WarningsExact identifier
unii: J41CSQ7QDS
Refresh Digital PFCARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN AND POLYSORBATE 80Allergan, Inc.97e83e68-6374-4df4-93f6-d707fc32748d2022-11-28WarningsExact identifier
unii: PDC6A3C0OX
Refresh DigitalCARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN, POLYSORBATE 80Allergan, Inc.b2bd34d4-fab9-4f4b-9be2-5d30b55f5b812022-11-28WarningsExact identifier
unii: PDC6A3C0OX
Sterile WaterWATERFresenius Kabi USA, LLCb45e9f1d-9c48-4b46-8541-d846b89540df2022-10-26Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Eye washPURIFIED WATERMcKessonbd089fde-24ba-4de5-e053-2995a90a39bb2022-10-18WarningsExact identifier
unii: 059QF0KO0R
Systemic DetoxBOLDO, CARDUUS MARIANUS, CHELIDONIUM MAJUS, SARSAPARILLA (SMILAX REGELII), GELSEMIUM SEMPERVIRENS, VERATRUM ALBUM, FERRUM METALLICUM, IODIUM, LYCOPODIUM CLAVATUM, NUX VOMICA, PULSATILLA (PRATENSIS), SELENIUM METALLICUM, THUJA OCCIDENTALIS, ZINCUM METALLICUMDeseret Biologicals, Inc.8af4c01e-1d41-4e76-ba89-fa7908cd90982022-10-11WarningsExact identifier
unii: J41CSQ7QDS

Reported adverse events (FAERS/openFDA)#

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