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 98 of 133 · 2,657 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Muro 128SODIUM CHLORIDEBausch & Lomb Incorporatedcc3d5bc8-9d3c-4c65-9e43-707a2db4081a2024-09-25WarningsExact identifier
unii: 451W47IQ8X
Muro 128SODIUM CHLORIDEBausch & Lomb Incorporated93fafa27-5031-4d95-b4b8-5574b7204ae22024-09-25WarningsExact identifier
unii: 451W47IQ8X
Muro 128SODIUM CHLORIDEBausch & Lomb Incorporated454f337e-d897-46de-ab05-1c543a33061c2024-09-25WarningsExact identifier
unii: 451W47IQ8X
AOSI HEALTHCARE BURNLIDOCAINE HYDROCHLORIDE, BENZALKONIUM CHLORIDENantong Health & Beyond Hygienic Products Inc.a28b920c-0bb8-4b5a-addd-26ea164e036e2024-09-25WarningsExact identifier
unii: F5UM2KM3W7
DefensePETROSELINUM SATIVUM, NATRUM MURIATICUM, HEPAR (BOVINE), MEDULLA OSSIS SUIS, SPLEEN (BOVINE), THYMUS (OVINE), SACCHARINUMNutritional Specialties, Inc.ddd879cf-1a85-4b8d-bdb0-5cf495fea4e62024-09-24WarningsExact identifier
unii: 451W47IQ8X
DexamethasoneDEXAMETHASONEBryant Ranch Prepacke652b041-2a0b-4bcd-a420-5d026302edbb2024-09-23Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL
HP AxisARGENTUM NITRICUM, BERBERIS VULGARIS, IODIUM, KALI CARBONICUM, NATRUM MURIATICUM, ADRENALINUM, CORTISONE ACETICUM, DHEA, GLANDULA SUPRARENALIS SUIS, HYPOPHYSIS SUIS, HYPOTHALAMUS SUIS, MELATONIN, TESTOSTERONE, ARSENICUM ALBUM, PHOSPHORUS, PROTEUS (VULGARIS), SEPIA, SILICEA, ALLOXANUM, CORTICOTROPIN RELEASING HORMONE, ADRENOCORTICOTROPHIN, ALDOSTERONEDeseret Biologicals, Inc.402f5b05-c71e-4dba-bc2b-049aee42952a2024-09-23WarningsExact identifier
unii: 451W47IQ8X
triple antibioticBACITRACIN ZINC, NEOMYCIN, POLYMYXIN BPadagis Israel Pharmaceuticals Ltd28fff253-ddd4-4669-aa90-b4caf48c905f2024-09-22WarningsExact identifier
unii: 057Y626693
unii: 19371312D4
Signature Care Triple AntibioticBACITRACIN ZINC, NEOMYCIN, POLYMYXIN BSafeway044aff98-f398-40f5-8c18-2751b4ab43842024-09-18WarningsExact identifier
unii: 057Y626693
unii: 19371312D4
NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDINNEOMYCIN SULFATE, POLYMYXIN B SULFATE AND GRAMICIDINBausch & Lomb Incorporatede6f8d2f6-adff-4ae1-982c-45562f0a8e282024-09-18Warnings, Adverse reactionsExact identifier
unii: 057Y626693
unii: 19371312D4
Dial antibacterial and sensitive hypoallergenic barBENZALKONIUM CHLORIDEHenkel Corporation2269bac8-b724-feb8-e063-6394a90a52ff2024-09-18WarningsExact identifier
unii: F5UM2KM3W7
careone triple antibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEAmerican Sales Company09a0b0b9-1806-4ff9-80fa-448dabbf2cc72024-09-18WarningsExact identifier
unii: 057Y626693
unii: 19371312D4
equaline first aid antibioticBACITRACIN ZINC, NEOMYCIN, POLYMYXIN BUnited Natural Foods, Inc. dba UNFI022e009e-0192-4089-86f3-4d63448e0f882024-09-18WarningsExact identifier
unii: 057Y626693
unii: 19371312D4
Triple AntibioticBACITRACIN ZINC, NEOMYCIN, POLYMYXIN BKroger Companyc531bac4-ab15-4fde-99a7-19e20ce103872024-09-17WarningsExact identifier
unii: 057Y626693
unii: 19371312D4
basic care first aid antibioticBACITRACIN ZINC, NEOMYCIN, POLYMYXIN BAmazon.com Services LLCc159b18d-0d6e-409f-8b2b-e8f28cd856332024-09-17WarningsExact identifier
unii: 057Y626693
unii: 19371312D4
Dextrose and Sodium ChlorideDEXTROSE MONOHYDRATE AND SODIUM CHLORIDEFresenius Kabi USA, LLC3c5f0f65-8a54-4a55-ad4e-0f0be97631d72024-09-15Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Neomycin Polymyxin B Sulfates and DexamethasoneNEOMYCIN SULFATE, POLYMYXIN B SULFATE AND DEXAMETHASONEBausch & Lomb Incorporatedd6d78668-a978-4cd3-bbcd-1293b5044ec92024-09-15Warnings, Adverse reactionsExact identifier
application number: ANDA064135
ndc (product): 24208-830
rxcui: 309680
spl id: 22348d2e-ed9a-bb62-e063-6394a90aa6df
spl set id: d6d78668-a978-4cd3-bbcd-1293b5044ec9
unii: 057Y626693
unii: 7S5I7G3JQL
unii: 19371312D4
WhiskCare 377BENZALKONIUM CHLORIDEWhisk Products, Inc.124b403f-d12e-6e5c-e063-6394a90a63f82024-09-13WarningsExact identifier
unii: F5UM2KM3W7
Major Triple AntibioticBACITRACIN ZINC, NEOMYCIN, POLYMYXIN B SULFATMajor Pharmaceuticalsa6cc3fbc-6302-4033-e053-2a95a90a19f02024-09-11WarningsExact identifier
unii: 057Y626693
unii: 19371312D4
Thyroid HPBARYTA CARBONICA, CALCAREA CARBONICA, CALCAREA IODATA, FUCUS VESICULOSUS, IODIUM, NATRUM MURIATICUM, PULSATILLA (VULGARIS), SPONGIA TOSTA, THYROIDINUM (SUIS)Energique, Inc.3a4f9647-a4d9-4bca-96d1-ec717f938d4a2024-09-11WarningsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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