FDA.reportPublic FDA data

NDC 68083-384-01 - Neostigmine methylsulfate

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
68083-384
Requested NDC
68083-384-01
Package NDCs from labels
68083-384-01, 68083-384-10
Manufacturer
Gland Pharma Limited
Effective date
2026-09-21
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Neostigmine methylsulfate - Gland Pharma LimitedGland Pharma Limited2026-09-21Human Prescription Drug Label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68083-384-01Neostigmine methylsulfate1 in 1 CARTONINJECTION15
68083-384-01Neostigmine methylsulfate10 mL in 1 VIAL, MULTI-DOSEINJECTION105
68083-384-10Neostigmine methylsulfate10 in 1 CARTONINJECTION105

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68083-384NEOSTIGMINE METHYLSULFATE INJECTION [GLAND PHARMA LIMITED]4Current NDC, Legacy NDC, 3 package rows20210220_4eab6184-1771-4c15-a127-4eb3e47affc2.zip

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 10 of 20 · 389 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BACTERIOSTATIC WATERBACTERIOSTATIC WATERHF Acquisition Co LLC, DBA HealthFirst99b0ef9b-600a-40dc-e053-2a95a90aa07e2025-01-08Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
STERILE WATERSTERILE WATERHF Acquisition Co LLC, DBA HealthFirst99b1cb12-0b2d-0c0f-e053-2a95a90ac3b62025-01-08Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
ChemtoxTRITICUM AESTIVUM, BERBERIS VULGARIS, GLYCYRRHIZA GLABRA, LAPPA MAJOR, RHAMNUS FRANGULA, RHAMNUS PURSHIANA, STILLINGIA SYLVATICA, TRIFOLIUM PRATENSE, XANTHOXYLUM FRAXINEUM, PHYTOLACCA DECANDRA, GLANDULA SUPRARENALIS SUIS, HEPAR SUIS, LYMPH NODE (SUIS), THYROIDINUM (SUIS), BELLADONNA, LYCOPODIUM CLAVATUM, NITRICUM ACIDUM, NUX VOMICA, PHOSPHORICUM ACIDUM, PHOSPHORUS, SALICYLICUM ACIDUM, CORTISONE ACETICUM, EUGENOL, STEARYL ALCOHOL, XYLITOL, FOLLICULINUM, BENZOICUM ACIDUM, CHLORINUM, POTASSIUM SORBATE,BioActive Nutritional, Inc.a480e5f4-5f9e-4b23-b257-b0ac1ebfc1152025-01-07WarningsExact identifier
unii: Q40Q9N063P
Acetic AcidACETIC ACIDTruPharma, LLC0c5ebd59-0e98-4ea1-b279-9202a19f6dbf2024-12-27Warnings, Adverse reactionsExact identifier
unii: Q40Q9N063P
Neostigmine MethylsulfateNEOSTIGMINE METHYLSULFATECivica, Inc.454d54dc-b803-4519-81e8-ac7d21e6aae12024-12-26Warnings, Adverse reactionsExact identifier
rxcui: 311936
unii: 98IMH7M386
BiteMD External Analgesic First Aid AntisepticBENZOCAINE, CAMPHOR (SYNTHETIC), AND PHENOLUnited Industries Corporation4c60db03-6d2b-4ae0-a200-718b3a50eb0f2024-12-23WarningsExact identifier
unii: 339NCG44TV
Foster and Thrive Phenolated CalamineCALAMINE AND ZINC OXIDE AND PHENOLStrategic Sourcing Services LLC298171e1-2826-d33b-e063-6394a90a875a2024-12-17WarningsExact identifier
unii: 339NCG44TV
PHENOLPHENOLCHAIN DRUG MARKETING ASSOCIATION INC.2379e23a-72fe-4e94-9d7e-9b623c0db1742024-12-13WarningsExact identifier
unii: 339NCG44TV
Household DetoxALLIUM SATIVUM, ALUMINA, ANTIPYRINUM, BENZINUM, BISPHENOL A, CARBOLICUM ACIDUM, CARBONEUM SULPHURATUM, DIETHYLSTILBESTROL, DIOXIN, FOLLICULINUM, FORMALINUM, GLYPHOSATE, METHYLPARABEN, NAPHTHALINUM, PARAFFINUM, PETROLEUM, PHENACETINUM, PTELEA TRIFOLIATA, SODIUM CARBOXYMETHYL CELLULOSE, TEFLONDeseret Biologicals, Inc.7f79058a-c35a-429a-be3c-4cff1d6570872024-12-13WarningsExact identifier
unii: 339NCG44TV
Blistex MedicatedDIMETHICONE, CAMPHOR (SYNTHETIC), MENTHOL, AND PHENOLBlistex Inc.e95439d3-f12b-4c1c-999a-79f2ddba4cfb2024-12-11WarningsExact identifier
unii: 339NCG44TV
Mast Cell ProHYDRASTIS CANADENSIS, ASCORBICUM ACIDUM, CINCHONA OFFICINALIS, KIDNEY (SUIS), THIAMINUM HYDROCHLORICUM, URTICA DIOICA, APIS MELLIFICA, ARSENICUM ALBUM, BOVISTA, CARBOLICUM ACIDUM, COFFEA CRUDA, HISTAMINUM HYDROCHLORICUM, LACHESIS MUTUS, LEDUM PALUSTRE, NUX VOMICA, OXALICUM ACIDUM, PHOSPHORUS, RHUS TOX, SARCOLACTICUM ACIDUM, SECALE CORNUTUM, SEPIA, SEROTONIN (HYDROCHLORIDE), SULPHUR, THUJA OCCIDENTALIS, VENUS MERCENARIA, ACONITUM NAPELLUS, CALADIUM SEGUINUM, IGNATIA AMARA, NATRUM MURIATICUM,Energique, Inc.5cd31e1d-0312-48d1-9ecd-d01c6fe3b6722024-12-11WarningsExact identifier
unii: 339NCG44TV
Fendall Pure FlowPURIFIED WATERHoneywell Safety Products USA, Inc.afda6fc3-7615-b0be-e053-2995a90a62082024-12-10WarningsExact identifier
unii: 059QF0KO0R
Campho-Phenique Cold Sore TreatmentCAMPHOR (SYNTHETIC) AND PHENOLFoundation Consumer Healthcare LLC106c0bb2-f2e2-4255-867d-d09ff6a5a2e62024-12-02WarningsExact identifier
unii: 339NCG44TV
Campho-Phenique AntisepticCAMPHOR (SYNTHETIC) AND PHENOLFoundation Consumer Healthcare LLC82edaef0-0709-4ae1-a664-c9c5adb91ee12024-12-02WarningsExact identifier
unii: 339NCG44TV
Maximum Strength Cold Sore TreatmentCAMPHOR, MENTHOL, PHENOL, WHITE PETROLATUMMeijer Distribution Inc9220772c-b3b7-4855-e053-2a95a90a94f62024-11-27WarningsExact identifier
unii: 339NCG44TV
PhysiciansCare Ophthalmic Solution Eyewash Purified Water, 98.3%PURIFIED WATER 98.3%Acme United Corporation9248ee71-2d47-620d-e053-2995a90af5c82024-11-26WarningsExact identifier
unii: 059QF0KO0R
PhysiciansCare Ophthalmic Solution EyewashPURIFIED WATER 98.3%Acme United Corporationcca454e0-b2bd-4215-bc06-426fcc3f7bd62024-11-26WarningsExact identifier
unii: 059QF0KO0R
PhysiciansCare Ophthalmic Solution EyewashPURIFIED WATER 98.3%Acme United Corporationd3812fa3-9334-464d-b50c-98548ff767272024-11-26WarningsExact identifier
unii: 059QF0KO0R
DANGTTEOLMINERAL WATERAQBC CO., LTD27db14a9-3812-433f-e063-6394a90a11e72024-11-26WarningsExact identifier
unii: 059QF0KO0R
NICE SORE THROAT SpearmintPHENOLLeosons Overseas Corp5fc68f04-ec15-11c0-e053-2a91aa0a19522024-11-20WarningsExact identifier
unii: 339NCG44TV

Reported adverse events (FAERS/openFDA)#

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