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 35 of 36 · 718 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
Sterile Diluent for TreprostinilWATERDr.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
EyewashEYEWASHGlobal Equipment Companyc4f78121-4668-2e0c-e053-2995a90ab6c62021-06-17WarningsExact identifier
unii: 059QF0KO0R
OHM-INMAACONITUM NAPELLUS, ARANEA DIADEMA, ARNICA MONTANA, ASCLEPIAS VINCETOXICUM, BAPTISIA TINCTORIA, BRYONIA ALBA, ECHINACEA ANGUSTIFOLIA, EQUISETUM HYEMALE, EUPATORIUM PERFORLIATUM, GELSEMIUM SEMPERVIRENS, HEPAR SULPHURIS CALCAREUM, JUGLANS REGIA, PHYTOLACCA DECANDRA, SANGUINARIA CANADENSIS, SARSAPARILLA, SULPHUR, ZINCUM METALLICUMOHM PHARMA INC.bc8e72c7-b7e6-4d5d-bd37-75202244d4402021-03-25WarningsExact identifier
unii: J41CSQ7QDS
Metabolic ResetACETICUM ACIDUM, ANACARDIUM ORIENTALE, BARYTA IODATA, CALCAREA CARBONICA, CAPSICUM ANNUM, FOCUS VERSICULOSUS, GRAPHITES, NATRUM SULPHURICUM, PHYTOLACCA DECANDRA, STANNUM METALLICUM, THYROIDINUM, ZINCUM METALLICUMHanoun, Andrew Functional Medicine Inc.2a3dd066-ec16-493d-a3b2-2bb5eb2e321c2021-01-21WarningsExact identifier
unii: J41CSQ7QDS
Whole System EEPMERCURIUS CORROSIVUS,NUX VOMICA,HYOSCYAMINUM,CARCINOSINUM,GRAPHITES,ZINCUM METALLICUM,LILIUM TIGRINUM,CINCHONA OFFICINALIS,CAUSTICUM,COFFEA CRUDA,BELLADONNA,IGNATIA AMARA,SCROPHULARIA NODOSA,SPONGIA TOSTA ,CEANOTHUS AMERICANUS,SENNA,HYDRASTIS CANADENSIS,CONDURANGO,CHELIDONIUM MAJUS,PITUITARY GLAND, BOS TAURUS,PANCREAS SUIS,LYCOPODIUM CLAVATUM,BERBERIS VULGARIS,White Manufacturing Inc. DBA Micro-West6fe11fe3-6725-4701-8461-25d4e885a6c42021-01-21WarningsExact identifier
unii: J41CSQ7QDS
Met-ToxARSENICUM ALBUM, AVENA SATIVA,LYCOPODIUM CLAVATUM,NATRUM MURIATICUM,NUX VOMICA,PHYTOLACCA DECANDRARHAMNUS FRANGULA,SOLIDAGO VIRGAUREA,TRIFOLIUM PRATENSE,HEAVY METAL NOSODESwHITE mANUFACTURING INC DBA MICRO-WESTe65db4c2-0bc7-4c50-8f18-b36ee004c4f52021-01-21WarningsExact identifier
unii: J41CSQ7QDS
Sterile WaterWATERAsclemed USA, Inc.45c38269-883c-4198-a9d5-03810a4420ec2021-01-14Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Prime of LifeAGNUS, ALLIUM SATIVUM, AMBRA, ANGELICA SINENSIS RADIX, ARALIA QUINQUEFOLIA, ARNICA, ARSENICUM ALB., AVENA, BAPTISIA, BARYTA CARB., BRYONIA, CANTHARIS, LACHESIS, LYCOPODIUM, NUX VOM., PHOSPHORICUM AC., PULSATILLA, RUTA, SABAL, SELENIUM, ZINC. MET., GINKGONewton Laboratories, Inc.99751ba5-77c2-2e89-e053-2a95a90a12692020-12-07WarningsExact identifier
unii: J41CSQ7QDS
Varicose VeinsELAPS CORALLINUS, CROTALUS HORRIDUS, BRYONIA, CALC. FLUOR., CARDUUS MAR., CHOLESTERINUM, CINCHONA, DIGITALIS, HAMAMELIS, HYDROFLUORICUM ACIDUM, LACHESIS, LYCOPODIUM, NAJA, PULSATILLA, VIPERA BERUS, ZINC. MET., AESCULUS HIPP., ECHINACEANewton Laboratories, Inc.999b04b4-ffee-3532-e053-2a95a90a06622020-12-07WarningsExact identifier
unii: J41CSQ7QDS
FungalCANDIDA ALBICANS, SANICULA, TELLURIUM METALLICUM, TORULA CEREVISIAE, ANTIMON. CRUD., ARSENICUM ALB., BARYTA CARB., BRYONIA, CALC. CARB., CARBO VEG., CUPRUM MET., DULCAMARA, GRAPHITES, KALI CARB., LACHESIS, LYCOPODIUM, MEZEREUM, NITRICUM AC., PHOSPHORUS, PHYTOLACCA, SEPIA, SILICEA, SULPHUR, SULPHURICUM AC., ZINC. MET., APIS MEL., THUJA OCC.Newton Laboratories, Inc.99487f4a-76f6-407b-e053-2a95a90acfd42020-12-03WarningsExact identifier
unii: J41CSQ7QDS
Acne - Cystic AcneECHINACEA, JUGLANS REGIA, LAPPA MAJOR, TARAXACUM OFFICINALE, ANTIMONIUM CRUDUM, ARSENICUM ALBUM, AURUM METALLICUM, BERBERIS AQUIFOLIUM, BOVISTA, CARBO VEGETABILIS, CAUSTICUM, CHELIDONIUM MAJUS, DULCAMARA, GRAPHITES, HEPAR SULPHURIS CALCAREUM, HYDROCOTYLE ASIATICA, KALI BROMATUM, KALI IODATUM, LEDUM PALUSTRE, LYCOPDIUM CLAVATUM, NUX VOMICA, SULPHUR IODATUM, ZINCUM METALLICUM, SILICEANewton Laboratories, Inc92afe017-74c7-16c6-e053-2995a90a5c7d2020-12-02WarningsExact identifier
unii: J41CSQ7QDS
Feminine ComfortAGARICUS MUSC., ARSENICUM ALB., AUR. MET., BERBER. AQUI., CALADIUM SEGUINUM, CANDIDA ALBICANS, CANTHARIS, CONIUM, GRAPHITES, HELONIAS DIOICA, HYDRASTIS, KALI CARB., KREOSOTUM, LYCOPODIUM, MERC. VIV., MUREX PURPUREA, NAT. MUR., NITRICUM AC., PULSATILLA, RHUS TOXICODENDRON, SEPIA, SULPHUR, TARENTULA HISPANA, THUJA OCC., ZINC. MET., APIS MEL., HAMAMELISNewton Laboratories, Inc.9ab4520d-1dd3-7b9f-e053-2a95a90a274f2020-11-25WarningsExact identifier
unii: J41CSQ7QDS
AcneANTIMON. CRUD., ARSENICUM ALB., AUR. MET., BERBER. AQUI., BOVISTA, CARBO VEG., CAUSTICUM, CHELIDONIUM MAJUS, DULCAMARA, GRAPHITES, HEPAR SULPH. CALC., HYDROCOTYLE, KALI BROM., KALI IOD., LEDUM, LYCOPODIUM, NUX VOM., SILICEA, SULPHUR IOD., ZINC. MET., ECHINACEA, JUGLANS REGIA, LAPPA, TARAXACUMNewton Laboratories, Inc.798c853c-16ab-8502-e053-2a91aa0a65322020-11-24WarningsExact identifier
unii: J41CSQ7QDS

Reported adverse events (FAERS/openFDA)#

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