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
Label	Manufacturer	Effective date	Type
Insulin glargine U-300 - Sanofi-Aventis U.S. LLC \| Genzyme Corporation \| Sanofi-Aventis Deutschland GmbH	Sanofi-Aventis U.S. LLC \| Genzyme Corporation \| Sanofi-Aventis Deutschland GmbH	2025-05-30	HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0955-2900-01	Insulin glargine U-300 Max	3 mL in 1 SYRINGE	INJECTION, SOLUTION	3		7
0955-2900-02	Insulin glargine U-300 Max	2 in 1 CARTON	INJECTION, SOLUTION	2		7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0955-2900	INSULIN GLARGINE U-300 (INSULIN GLARGINE) INJECTION, SOLUTION INSULIN GLARGINE U-300 MAX (INSULIN GLARGINE) INJECTION, SOLUTION [WINTHROP U.S.]	6	Current NDC, 2 package rows	20240913_99ea856d-9562-443a-9422-1006a3cff2f4.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0955-2900-01	ML - Milliliter	0955-2900	d5f1116f-3b0d-4a22-b902-789dc1133f55	1	2024-02-14
0955-2900-02	ML - Milliliter	0955-2900	6dda0158-cc5b-4530-884a-73ea65000a7e	1	2024-02-14

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 26 of 36 · 718 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ear Ring	ALLIUM CEPA, ARGENTUM NITRICUM, CHENOPODIUM ANTHELMINTICUM, DULCAMARA, GINKGO BILOBA, CHININUM SULPHURICUM, CARTILAGO SUIS, MUCOSA NASALIS SUIS, ASARUM CANADENSE, ONOSMODIUM VIRGINIANUM, NATRUM SALICYLICUM, CARBO VEGETABILIS, CARBONEUM SULPHURATUM, CYCLAMEN EUROPAEUM, GOSSYPIUM HERBACEUM, GRAPHITES, KREOSOTUM, PHOSPHORUS, PLUMBUM METALLICUM, THERIDION, ZINCUM METALLICUM	Deseret Biologicals, Inc.	43585c0d-50da-411d-9f26-c8c0325dd9d5	2024-05-08	Warnings	Exact identifier unii: J41CSQ7QDS
Fatigue Stat CM	ECHINACEA (ANGUSTIFOLIA), LOMATIUM DISSECTUM, TABEBUIA IMPETIGINOSA, HYDRASTIS CANADENSIS, PHYTOLACCA DECANDRA, ARANEA DIADEMA, IPECACUANHA, IRIDIUM METALLICUM, LACHESIS MUTUS, MURIATICUM ACIDUM, RHUS TOX, CYTOMEGALOVIRUS NOSODE	Energique, Inc	aebdb08b-48aa-46f2-930f-f98f5b06a604	2024-05-08	Warnings	Exact identifier unii: QTT17582CB
Neurotransmitter Pro	AETHUSA CYNAPIUM, GINKGO BILOBA, KALI PHOSPHORICUM, CEREBRUM SUIS, HYPOTHALAMUS SUIS, ADENOSINUM TRIPHOSPHORICUM DINATRUM, ALUMINA, ANACARDIUM ORIENTALE, ARSENICUM ALBUM, CORTISONE ACETICUM, LEVOTHYROXINUM, LYCOPODIUM CLAVATUM, NADIDUM, PHOSPHORUS, UBIDECARENONUM, ZINCUM METALLICUM, ACETYLCHOLINE CHLORIDE, DOPAMINE HYDROCHLORIDE, GABA (GAMMA-AMINOBUTYRIC ACID), HISTAMINUM HYDROCHLORICUM, MELATONIN, NOREPINEPHRINE (BITARTRATE), OXYTOCIN, SEROTONIN (HYDROCHLORIDE)	Energique, Inc.	a80e5e2d-4c53-4b18-b89b-a7790073b7ed	2024-05-06	Warnings	Exact identifier unii: J41CSQ7QDS
Neurotransmitter Pro	AETHUSA CYNAPIUM, GINKGO BILOBA, KALI PHOSPHORICUM, CEREBRUM SUIS, HYPOTHALAMUS SUIS, ADENOSINUM TRIPHOSPHORICUM DINATRUM, ALUMINA, ANACARDIUM ORIENTALE, ARSENICUM ALBUM, CORTISONE ACETICUM, LEVOTHYROXINUM, LYCOPODIUM CLAVATUM, NADIDUM, PHOSPHORUS, UBIDECARENONUM, ZINCUM METALLICUM, ACETYLCHOLINE CHLORIDE, DOPAMINE HYDROCHLORIDE, GABA (GAMMA-AMINOBUTYRIC ACID), HISTAMINUM HYDROCHLORICUM, MELATONIN, NOREPINEPHRINE (BITARTRATE), SEROTONIN (HYDROCHLORIDE), OXYTOCIN	Energique, Inc.	b433c635-e38b-4b3a-89cb-4a72a386ad84	2024-05-06	Warnings	Exact identifier unii: J41CSQ7QDS
Fleet	GLYCERIN	C.B. Fleet Company, Inc.	381f4179-0c3b-41f8-927c-c88534ebe06d	2024-05-06	Warnings	Exact identifier unii: PDC6A3C0OX
REFL HS	ADENOSINUM TRIPHOSPHORICUM DINATRUM, NADIDUM, ARGENTUM NITRICUM, IPECACUANHA, ROBINIA PSEUDOACACIA, SULPHUR, ORIGANUM VULGARE, DUODENUM (SUIS), ESOPHAGUS (SUIS), FUNICULUS UMBILICALIS SUIS, STOMACH (SUIS), NUX VOMICA, COUMARINUM, ERYTHRAEA CENTAURIUM, PANCREAS SUIS, MURIATICUM ACIDUM, CITRICUM ACIDUM, FORMICUM ACIDUM, SARCOLACTICUM ACIDUM, COENZYME A, PROTEUS (MORGANI)	Deseret Biologicals, Inc.	83249aee-f58b-442d-9187-6de0cf070e4d	2024-04-29	Warnings	Exact identifier unii: QTT17582CB
Mineffect eye drops	ALUMINA SILICATA, CALCAREA FLUORICA, FERRUM METALLICUM, FERRUM PHOSPHORICUM, NATRUM MURIATICUM, PHOSPHORUS, SULPHUR, TITANIUM METALLICUM, ZINCUM METALLICUM	Kadesh Incoporation Co,Ltd	e2259f58-3043-4af3-918d-d4403757aa1f	2024-04-26	Warnings	Exact identifier unii: J41CSQ7QDS
VACC HC	HEPAR SUIS, HISTAMINUM HYDROCHLORICUM, THUJA OCCIDENTALIS, RNA, ECHINACEA (ANGUSTIFOLIA), LEDUM PALUSTRE, MEZEREUM, SILICEA, INFLUENZINUM, ANTIMONIUM TARTARICUM, ARSENICUM ALBUM, BRYONIA (ALBA), GELSEMIUM SEMPERVIRENS, HYOSCYAMUS NIGER, LAC FELINUM, MERCURIUS SOLUBILIS, NICOTINAMIDUM, SENEGA OFFICINALIS, SPIGELIA ANTHELMIA, SULPHUR, ZINCUM METALLICUM	Deseret Biologicals, Inc.	a98082ba-21ec-4cf8-b81c-bcb41eb9fd12	2024-04-23	Warnings	Exact identifier unii: J41CSQ7QDS
Glyreg	ACETICUM ACIDUM, CACAO, MAGNESIA SULPHURICA, NATRUM SULPHURICUM, VERBASCUM THAPSUS, GLANDULA SUPRARENALIS SUIS, PANCREAS SUIS, CORTISONE ACETICUM, THYROIDINUM (SUIS), IODIUM, LYCOPODIUM CLAVATUM, PHOSPHORUS, RANUNCULUS BULBOSUS, SACCHARUM OFFICINALE, VANADIUM METALLICUM, ZINCUM METALLICUM, CHROMIUM ACIDUM, CULEX MUSCA	Deseret Biologicals, Inc	28e670ca-ed35-4256-af20-74c25dc18099	2024-04-23	Warnings	Exact identifier unii: J41CSQ7QDS
PEMF Optimizer	AQUA SULIS, ARGENTUM METALLICUM, AURUM METALLICUM, CUPRUM METALLICUM, LAPIS ALBUS, MANGANUM METALLICUM VANADIUM METALLICUM VISCUM ALBUM, ZINCUM METALLICUM	Deseret Biologicals, Inc.	97d57469-4c5b-4d3f-9398-3a1a6617a649	2024-04-23	Warnings	Exact identifier unii: 059QF0KO0R unii: J41CSQ7QDS
Free Radistat	BAPTISIA TINCTORIA, ECHINACEA (ANGUSTIFOLIA), FUCUS VESICULOSUS, UVA-URSI, PHYTOLACCA DECANDRA, ARSENICUM ALBUM, AURUM METALLICUM, FERRUM PHOSPHORICUM, IODIUM, IRIDIUM METALLICUM, LACHESIS MUTUS, ZINCUM METALLICUM, CADMIUM SULPHURATUM	Energique, Inc.	1427d5af-497b-4585-aba9-3a8fdcd7745c	2024-04-22	Warnings	Exact identifier unii: J41CSQ7QDS
Ligapar	LAPPA MAJOR, LIGAMENT (HUMAN), CARTILAGO SUIS, ARNICA MONTANA, BRYONIA (ALBA), CALCAREA PHOSPHORICA, CAUSTICUM, RHODODENDRON CHRYSANTHUM, RHUS TOX, RUTA GRAVEOLENS, SILICEA, ZINCUM METALLICUM	Energique, Inc.	17f6b1f5-8e49-49df-bad4-9c19fa677e69	2024-04-22	Warnings	Exact identifier unii: J41CSQ7QDS
EVTOX	COCHLEARIA OFFICINALIS, ECHINACEA (ANGUSTIFOLIA), HYDRASTIS CANADENSIS, LOMATIUM DISSECTUM, TABEBUIA IMPETIGINOSA, PROPOLIS, GLANDULA SUPRARENALIS SUIS, THYMUS (SUIS), ARANEA DIADEMA, IPECACUANHA, LYCOPODIUM CLAVATUM, MURIATICUM ACIDUM, NITRICUM ACIDUM, RHUS TOX, SILICEA, EPSTEIN-BARR VIRUS NOSODE	BioActive Nutritional, Inc.	4b518e10-9ce0-492b-92be-6025d8d7c3c6	2024-04-19	Warnings	Exact identifier unii: QTT17582CB
Enviro I	POTASSIUM GLUCONATE, GLANDULA SUPRARENALIS SUIS, HEPAR SUIS, COFFEA TOSTA, THEA SINENSIS, CARBO VEGETABILIS, FERRUM IODATUM, FERRUM METALLICUM, GELSEMIUM SEMPERVIRENS, IODIUM, IRIDIUM METALLICUM, LYCOPODIUM CLAVATUM, PULSATILLA (PRATENSIS), SELENIUM METALLICUM, ZINCUM METALLICUM, PEANUT, BLACK WALNUT, ENGLISH WALNUT, AMYGDALA AMARA, CASHEW, COCONUT, PECAN, BRAZIL NUT, TOMATO, SOLANUM TUBEROSUM, PIPER NIGRUM, EGGPLANT, RAPE SEED OIL, LINUM USITATISSIMUM, SESAME, SEED, CHEESE (STILTON), LAC VACCINUM, BEEF,	Deseret Biologicals, Inc.	1de4f602-6e3c-4142-b60a-90585ac33884	2024-04-17	Warnings	Exact identifier unii: J41CSQ7QDS
Male Stimulant	ARALIA QUINQUEFOLIA, AGNUS CASTUS, ASCORBICUM ACIDUM, CALADIUM SEGUINUM, KALI BROMATUM, CANTHARIS, DAMIANA, FUNICULUS UMBILICALIS SUIS, GLANDULA SUPRARENALIS SUIS, HYPOPHYSIS SUIS, ORCHITINUM (SUIS), PROSTATE (SUIS), STRYCHNINUM PHOSPHORICUM, CONIUM MACULATUM, DIENCEPHALON (SUIS), HEART (SUIS), FERRUM PHOSPHORICUM, MAGNESIA PHOSPHORICA, SELENIUM METALLICUM, ZINCUM METALLICUM, PINEAL GLAND (SUIS), CORTISONE ACETICUM, MANGANUM PHOSPHORICUM, LYCOPODIUM CLAVATUM, TESTOSTERONE, MORGAN GAERTNER	Deseret Biologicals, Inc.	d48437d6-a54f-4e11-bcfb-9e0d5c1e98da	2024-04-15	Warnings	Exact identifier unii: J41CSQ7QDS
Sterile Water	WATER	Hikma Pharmaceuticals USA Inc.	78ef7ad3-451d-43d0-a9b6-5cf0aadca003	2024-04-10	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
Sterile Water	WATER	B. Braun Medical Inc.	8fc8d87a-3951-4ac5-97df-c161ffc90475	2024-04-10	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
PREPARATION H Maximum Strength	GLYCERIN, PETROLATUM, PHENYLEPHRINE HCL, PRAMOXINE HCL	Haleon US Holdings LLC	7cc03d2e-e708-589a-d9bb-58ebbda989c0	2024-04-05	Warnings	Exact identifier unii: PDC6A3C0OX
Eye Wash	WATER	M-star (Hubei) Health&Care Products Co., Ltd.	71706039-e250-4f08-9687-71b2928c4e46	2024-04-01	Warnings	Exact identifier unii: 059QF0KO0R
Oral Health	ANTIMONIUM CRUDUM, ARSENICUM ALBUM, BISMUTHUM SUBNITRICUM, BORAX, BRYONIA (ALBA), CALCAREA PHOSPHORICA, CANDIDA ALBICANS, CHAMOMILLA, CINCHONA OFFICINALIS, DISCUS INTERVERTEBRALIS SUIS, STREPTOCOCCUS DYSGALACTIAE DNA, STREPTOCOCCUS MUTANS DNA, STREPTOCOCCUS PNEUMONIAE DNA, ECHINACEA PURPUREA, IGNATIA AMARA, JUGLANS CINEREA, KALI MURIATICUM, MAGNESIA MURIATICA, MERCURIUS SOLUBILIS, MURIATICUM ACIDUM, NUX MOSCHATA, ORAL MUCOSA (SUIS), OXYGENIUM, SAMBUCUS NIGRA, SEPIA, STAPHYLOCOCCUS AUREUS,	Deseret Biologicals, Inc.	6f66ff40-6e0e-4a35-963c-965c65df76eb	2024-04-01	Warnings	Exact identifier unii: QTT17582CB

Reported adverse events (FAERS/openFDA)#

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