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 34 of 36 · 710 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sterile WaterWATERFresenius Kabi USA, LLCf42ac50f-0ec5-4713-a4c8-99d972d90bed2022-06-22Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERFresenius Kabi USA, LLCe71c6c83-d518-496c-b2ab-efd5987e47832022-06-09Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
AddiclenzBETA VULGARIS, BOLDO, CHELIDONIUM MAJUS, PETROSELINUM SATIVUM, TARAXACUM OFFICINALE, ARSENICUM ALBUM, BISPHENOL A, COBALTUM METALLICUM, CUPRUM METALLICUM, GLYPHOSATE, IODIUM, LYCOPODIUM CLAVATUM, PHOSPHORICUM ACIDUM, SELENIUM METALLICUM, ZINCUM METALLICUM, ASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYL PARABEN, PROPYL PARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUMDeseret Biologicals, Inc.e39235ea-2a2f-44a7-92d6-fb1d428ebabd2022-05-12WarningsExact identifier
unii: J41CSQ7QDS
Miracle FootCream LavenderUREA, GLYCERIN, ALOE, DISODIUM EDTAAloe Vera Korea Co.,Ltd.db520c80-2a2a-5eb1-e053-2995a90a5bb42022-03-28WarningsExact identifier
unii: PDC6A3C0OX
Miracle FootCream LemonUREA, GLYCERIN, ALOE, DISODIUM EDTAAloe Vera Korea Co.,Ltd.db525c63-29fd-2033-e053-2995a90a56b92022-03-28WarningsExact identifier
unii: PDC6A3C0OX
ACNE HPCARBO ANIMALIS, ACTIVATED CHARCOAL, POTASSIUM DICHROMATE, SODIUM CHLORIDE, PULSATILLA VULGARIS, SEPIA OFFICINALIS JUICE, SILICON DIOXIDE, SULFUR, ZINCNatural Creations, Inc.b2368ab6-e233-4473-99fa-86e1fbc2a8792022-02-14WarningsExact identifier
unii: J41CSQ7QDS
Drink EaseAVENA SATIVA FLOWERING TOP, CAPSICUM, STRYCHNOS NUX-VOMICA SEED, VERATRUM ALBUM ROOT, AND ZINCMiers Laboratories23317bc3-deac-4756-8f99-d08fa32fbbfc2022-02-04WarningsExact identifier
unii: J41CSQ7QDS
Sterile WaterWATERAmerican Regent, Inc.78b35864-4bbc-4759-a5c1-7e4f25e229322022-01-31Boxed warningExact identifier
unii: 059QF0KO0R
BHI HemorrhoidHORSE CHESTNUT, ALOE, COLLINSONIA CANADENSIS ROOT, VERONICASTRUM VIRGINICUM ROOT, HYDROCHLORIC ACID, STRYCHNOS NUX-VOMICA SEED, PAEONIA OFFICINALIS ROOT, AND SULFURMediNatura Incd7df7d3e-48ad-4f58-aef5-a7bd48d2f1912022-01-05WarningsExact identifier
unii: QTT17582CB
FLU TERMINATOR DROPSGELSEMIUM, ZINCUM GLUCONICUM, ZINCUM METALLICUM, ACONITUM NAPELLUS, EUPATORIUM PERFOLIATUM, SULPHUR, PHOSPHORUS, ASCLEPIAS VINCETOXICUM, INFLUENZINUM, ANAS BARBARIAE.Be Well Medical dba Richard Clement Nutrition y Be Well Homeopathicsc818b723-e038-47b0-940a-f2bb7edfd69c2021-12-29WarningsExact identifier
unii: J41CSQ7QDS
Phase 6 DropsTARAXACUM OFF, GALIUM APARINE, THUJA, ALOE, PHYTOLACCA, EUPHORBIUM OFFICINARUM, ZINCUM METALLICUM, ARSENICUM ALBUM, VISCUM ALBUM, CONIUM MACULATUM, HISTAMINUM HYDROCHLORICUM, FORMICUM ACIDUMBe Well Medical dba Richard Clement Nutrition y Be Well Homeopathicsaf7aaff0-5840-45a7-9bd6-2052fd6f26f32021-12-29WarningsExact identifier
unii: J41CSQ7QDS
DetoxBETA VULG, BOLDO, CHELIDONIUM MAJ, SARSAPARILLA, GELSEMIUM, VERATRUM ALB, FERRUM MET, IODIUM, LYCOPODIUM, NUX VOM, PULSATILLA, SELENIUM, THUJA OCC, ZINC METCompass Fat Loss of Glastonbury LLC927ba08e-54b0-4100-903d-c6f3521ab1852021-12-29WarningsExact identifier
unii: J41CSQ7QDS
Joette Calabrese Survivalist KitABROT ACON AGN AIL AMBR AMBRO AM-C ANT-C APIS ARN ARS AUR-A AUR BAPT BAR-C BELL BB BOTH BOV BROM CADM-S CALAD CALC CAMPH CARB-AC CARD-M CEAN CHEL CHININ-A CINA CHIN CIC COB COLCH CON CROT-H CROT-T CUPR DULC ELAPS EUP-PER FL-AC GALPH GRAPH GUNP HAM HEKLA HELL HEP HYDR-AC HYOS HYPER KALI-BR KALI-C KALI-I LATH LAUR LED LOB MERC-CY MERC MEZ MOSCH MUR-AC NAJA NAT-C NIT-AC NUX-M PYROG PH-AC PIC-AC PLB RHUS-T RUTA SAMB SANG SARR SEP STRAM SUL-AC TAB TERENT TER TEUCR VERAT VERAT-V VIPOHM PHARMA INC.1ac2a2c4-704e-4efa-aa44-acc71d300f702021-12-29WarningsExact identifier
unii: QTT17582CB
Weight ControlACETICUM AC, ANACARD OR, BARYTA IOD, CALC CARB, CAPSICUM, FUCUS, GRAPHITES,, NAT SULPHURICUM, PHYTOLACCA, STANNUM MET, THYROIDINUM, ZINC MET.OHM PHARMA INC.32b7b539-ee54-4c80-a6d9-c159600927f52021-12-29WarningsExact identifier
unii: J41CSQ7QDS
Healthy Start Weight and Appetite SupportACETICUM ACIDUM, ANACARDIUM ORIENTALE, BARYTA IODATA, CALCAREA CARBONICA, CAPSICUM ANNUM, FUCUS VESICULOSUS, GRAPHITES, NATRUM SULPHURICUM, PHYTOLACCA DECANDRA, STANNUM METALLICUM, THYRDOIDINUM, ZINUM METALLICUMWELL BODY CONCEPTS LLCd11b070a-2b55-4b79-933b-c628a38f584e2021-12-29WarningsExact identifier
unii: J41CSQ7QDS
TreprostinilTREPROSTINILDr.Reddy's Laboratories Inc.,33050ee2-519b-1f0b-d4df-9e14dd329c572021-12-23Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
ZINCUM METALLICUMZINCUM METALLICUMRxhomeo Private Limited d.b.a. Rxhomeo, Incf1e33d8b-91cb-4cd7-baeb-a5994b1a1b782021-10-03WarningsExact identifier
unii: J41CSQ7QDS
Sterile WaterSTERILE WATERB. Braun Medical Inc.d99f9133-e4d0-4dee-b611-dbc3f918b5472021-08-09Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERB. Braun Medical Inc.8924e52e-8622-4ed6-a061-1908183e0a182021-08-06Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
FungisodeARSENICUM ALBUM, BERBERIS VULGARIS, CALCAREA CARBONICA, CANDIDA ALBICANS, CARBO VEGETABILIS, CHELIDONIUM MAJUS, ECHINACEA PURPUREA, HEPAR SULPHURIS CALCAREUM, KREOSOTUM, LYCOPODIUM CLAVATUM, MERCURIUS SOLUBILIS, MURIATICUM ACIDUM, NITRICUM ACIDUM, OXALICUM ACIDUM, SEPIA OFFICINALIS, SULPHURSeroyal USA55c5dfc4-3757-6ac2-e054-00144ff88e882021-07-22WarningsExact identifier
unii: QTT17582CB

Reported adverse events (FAERS/openFDA)#

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