FDA.reportPublic FDA data

NDC 68071-4375-05 - Neomycin Polymyxin B Sulfates and Dexamethasone

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
68071-4375
Requested NDC
68071-4375-05
Package NDCs from labels
68071-4375-5, 68071-4375-05
Manufacturer
NuCare Pharmaceuticals,Inc.
Effective date
2024-06-07
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Neomycin Polymyxin B Sulfates and Dexamethasone - NuCare Pharmaceuticals,Inc.NuCare Pharmaceuticals,Inc.2024-06-07HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2023-06-15Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Suspension, USP (Sterile)
2023-01-30Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Suspension, USP (Sterile)
2021-02-16Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Suspension, USP (Sterile)
2021-01-29Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Suspension, USP (Sterile)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-4375-5Neomycin Polymyxin B Sulfates and Dexamethasone5 mL in 1 BOXSUSPENSION/ DROPS57

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-4375NEOMYCIN POLYMYXIN B SULFATES AND DEXAMETHASONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND DEXAMETHASONE) SUSPENSION/ DROPS [NUCARE PHARMACEUTICALS,INC.]7Current NDC, Legacy NDC, 1 package rows20240608_691bc5ca-5d61-60c2-e053-2991aa0abb93.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 83 of 134 · 2,662 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PURELL Antimicrobial Fragrance Free Foaming Hand SPBENZALKONIUM CHLORIDEGOJO Industries, Inc.4477d823-3658-43ac-bb51-fd20888606c92024-12-31WarningsExact identifier
unii: F5UM2KM3W7
Tobramycin and DexamethasoneTOBRAMYCIN AND DEXAMETHASONEAdvanced Rx of Tennessee, LLC09315f0b-f15a-30d5-e063-6394a90ac8dd2024-12-31Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL
NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONENEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONEAdvanced Rx Pharmacy of Tennessee, LLCf1a05d5f-74f2-17a1-e053-2995a90ab0e72024-12-31Warnings, Adverse reactionsExact identifier
unii: 057Y626693
unii: 7S5I7G3JQL
unii: 19371312D4
Tobramycin and dexamethasoneTOBRAMYCIN AND DEXAMETHASONEAdvanced Rx Pharmacy of Tennessee, LLCf4c00d9c-3a17-06a0-e053-2a95a90a84132024-12-31Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL
DexamethasoneDEXAMETHASONEAdvanced Rx Pharmacy of Tennessee, LLCfa16db27-3c8c-eb22-e053-6394a90add592024-12-31Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL
Citrus Fresh Liquid AntimicrobialBENZALKONIUM CHLORIDEHillyard GMP8abcace0-08b7-45ea-8f4f-cc74417db58a2024-12-31WarningsExact identifier
unii: F5UM2KM3W7
Citrus Fresh Foaming AntimicrobialBENZALKONIUM CHLORIDEHillyard GMP086b7f58-59f3-429e-a2d8-8a5ffed0f8202024-12-31WarningsExact identifier
unii: F5UM2KM3W7
Hillyard Alcohol Free Foaming Instant Hand SanitizerBENZALKONIUM CHLORIDEHillyard GMPa066bd4e-8f1d-4dfe-8754-fc7fd5ae48f92024-12-30WarningsExact identifier
unii: F5UM2KM3W7
KEEPAN ABENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDESato Pharmaceutical Co., Ltd.a30679d5-5507-499d-9d9f-498095fd32ac2024-12-30WarningsExact identifier
unii: F5UM2KM3W7
Neomycin and Polymyxin B Sulfates and DexamethasoneNEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONENuCare Pharmaceuticals,Inc.a7e55c43-4345-4710-e053-2995a90aeee72024-12-30Warnings, Adverse reactionsExact identifier
unii: 057Y626693
unii: 7S5I7G3JQL
unii: 19371312D4
Bacitracin Zinc and Polymyxin B SulfateBACITRACIN ZINC AND POLYMYXIN B SULFATENuCare Pharmaceuticals,Inc.a73654f4-949d-3da4-e053-2995a90a1fc32024-12-30Warnings, Adverse reactionsExact identifier
unii: 19371312D4
Total Solutions Hygien HandBENZALKONIUMAthea Laboratories, Inc.fcd63fe4-a357-4432-a738-ae1bccbb8bae2024-12-30WarningsExact identifier
unii: F5UM2KM3W7
Hillyard E2 Food Industry FoamingBENZALKONIUM CHLORIDEHillyard GMP81148442-6ee2-4655-85e4-27c2753c5c272024-12-30WarningsExact identifier
unii: F5UM2KM3W7
Gut Brain SpectrumABROTANUM (ARTEMISIA ABROTANUM), AETHUSA CYNAPIUM, BAPTISIA TINCTORIA, CICUTA VIROSA, CUPRUM METALLICUM, MEZEREUM, BUFO RANA, LAC MATERNA HUMANUM, SACCHARUM OFFICINALE, SEROTONIN (HYDROCHLORIDE), ALUMINA, CALCAREA PHOSPHORICA, CANDIDA ALBICANS, CARCINOSIN, LAC CANINUM, MERCURIUS SOLUBILIS, NATRUM MURIATICUM, PROPIONIC ACID, SULPHUR, THUJA OCCIDENTALIS, FORMALINUM, MORBILLINUMEnergique, Inc.adfee6ce-05b0-4955-bf5f-9612b8db4c782024-12-26WarningsExact identifier
unii: 451W47IQ8X
AMERICAN RED CROSS ANTISEPTIC CLEANSINGBENZALKONIUMMY IMPORTS USA LLC2a23da19-aca0-6d86-e063-6394a90ad52e2024-12-25WarningsExact identifier
unii: F5UM2KM3W7
AMERICAN RED CROSS ANTISEPTIC CLEANSINGBENZALKONIUMZhejiang Guoyao Jingyue Aerosol Co., Ltd.29ff1d68-06f7-e133-e063-6294a90a61542024-12-24WarningsExact identifier
unii: F5UM2KM3W7
TREE ANTIGENPOPULUS TRISTIS POLLEN, JUGLANS NIGRA POLLEN, ACER NEGUNDO POLLEN, ALNUS RUBRA POLLEN, JUNIPERUS VIRGINIANA POLLEN, ULMUS RUBRA POLLEN, ACER PSEUDOPLANUS POLLEN, FRAXINUS AMERICANA POLLEN, CARYA TOMENTOSA POLLEN, ONION, ARSENIC TRIOXIDE, ATROPA BELLADONNA, ACTIVATED CHARCOAL, EUPHRASIA OFFICINALIS, LYCOPODIUM CLAVITUM SPORE, SODIUM CHLORIDE, STRYCHNOS NUX-VOMICA SEED, PULSITILLA VULGARIS WHOLENatural Creations, Inc8040ab36-90eb-4076-a478-9b82ccfa4ec92024-12-23WarningsExact identifier
unii: 451W47IQ8X
Sterile Hypertonic Saline Solution 7 Sodium ChlorideSODIUM CHLORIDEJOONEM LLCe7110525-9f9b-5b68-e053-2995a90ac0342024-12-23WarningsExact identifier
unii: 451W47IQ8X
Base Laboratories SalineSODIUM CHLORIDEJoonem LLC49309411-9af4-4f19-a3bf-dbeabc1068272024-12-23WarningsExact identifier
unii: 451W47IQ8X
Base Laboratories SalineSODIUM CHLORIDEJoonem LLCba0868f6-d3de-40e2-bcb3-144fa53062c72024-12-23WarningsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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