FDA.reportPublic FDA data

NDC 68083-174-01 - POLYMYXIN B

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
68083-174
Requested NDC
68083-174-01
Package NDCs from labels
68083-174-01, 68083-174-10
Manufacturer
Gland Pharma Limited
Effective date
2025-05-09
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
POLYMYXIN B - Gland Pharma LimitedGland Pharma Limited2025-05-09Human Prescription Drug Label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68083-174-01POLYMYXIN B1 in 1 VIALINJECTION, POWDER, LYOPHILIZED,19
68083-174-10POLYMYXIN B10 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,109

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68083-174POLYMYXIN B (POLYMYXIN B SULFATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [GLAND PHARMA LIMITED]9Current NDC, Legacy NDC, 2 package rows20250514_dc74dee2-1d0b-4fab-a29b-1755fdb5da75.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 18 of 19 · 366 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EVERLIT CARE Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATENantong Health & Beyond Hygienic Products Inc.f4921508-c32f-426f-a2f0-16c3acbd47132023-10-14WarningsExact identifier
unii: 19371312D4
MAXITROLNEOMYCIN SULFATE, POLYMYXIN B SULFATE AND DEXAMETHASONENovartis Pharmaceuticals Corporation22c6d2db-85af-4a3b-a014-80d901a867172023-06-27Warnings, Adverse reactionsExact identifier
unii: 19371312D4
Bactine Max Antibiotic and Lidocaine Max Pain ReliefLIDOCAINEWellSpring Pharmaceutical Corporation71300df9-6113-4f25-93ca-28ad7e7f79de2023-06-08WarningsExact identifier
unii: 19371312D4
Neomycin and Polymyxin B Sulfates and DexamethasoneNEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND DEXAMETHASONEBausch & Lomb Incorporated4456d10b-9995-4430-b692-a8859ea36deb2023-06-01Warnings, Adverse reactionsExact identifier
unii: 19371312D4
Neomycin and Polymyxin B Sulfates and DexamethasoneNEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND DEXAMETHASONEProficient Rx LP21c9b34c-af88-4c9e-9b6c-32d78d34ba7e2023-05-01Warnings, Adverse reactionsExact identifier
unii: 19371312D4
Neomycin and Polymyxin B Sulfates and Hydrocortisone Otic SuspensionNEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE OTICA-S Medication Solutionsc895676f-446a-4a93-a3d2-addcce96b1082023-01-23Warnings, Adverse reactionsExact identifier
unii: 19371312D4
Polymyxin BPOLYMYXIN B SULFATEFresenius Kabi USA, LLC72dd6de6-31d6-4a8f-881b-91af91ed93142022-12-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 204509
unii: 19371312D4
Neomycin Polymyxin B Sulfates and DexamethasoneNEOMYCIN SULFATE, POLYMYXIN B SULFATE AND DEXAMETHASONEProficient Rx LP548089f3-29d8-4ba8-af21-9e04356ac29c2022-10-01Warnings, Adverse reactionsExact identifier
unii: 19371312D4
Neomycin and Polymyxin B Sulfates and HydrocortisoneNEOMYCIN SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONEProficient Rx LPf5ef71ae-fca9-4a57-ae88-f2b2d195a1792022-08-01Warnings, Adverse reactionsExact identifier
unii: 19371312D4
Neomycin and Polymyxin B Sulfates and HydrocortisoneNEOMYCIN SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONEProficient Rx LP98042cef-2839-49d6-a7bd-a1d29c74430b2022-05-02Warnings, Adverse reactionsExact identifier
unii: 19371312D4
Neomycin and Polymyxin B Sulfates and HydrocortisoneNEOMYCIN SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONEProficient Rx LP601cab21-c211-4c34-be7b-f4fdd97a921a2022-05-02Warnings, Adverse reactionsExact identifier
unii: 19371312D4
Polymyxin BPOLYMYXIN B SULFATEHikma Pharmaceuticals USA Inc.18daf0d1-b6f5-46f4-ab2f-01a594f3959c2022-04-28Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 204509
unii: 19371312D4
Polymyxin B Sulfate and TrimethoprimPOLYMYXIN B SULFATE AND TRIMETHOPRIMProficient Rx LP1252b997-3a81-4f3c-90e4-92f29ba157132022-04-01Warnings, Adverse reactionsExact identifier
unii: 19371312D4
Polymyxin B Sulfate and TrimethoprimPOLYMYXIN B SULFATE AND TRIMETHOPRIM SULFATEProficient Rx LPd1f55327-156f-44cd-b0fc-b1a938e8aa732022-04-01Warnings, Adverse reactionsExact identifier
unii: 19371312D4
CuadridermaBACITRACIN ZINC, POLYMYXIN B SULFATE, NEOMYCIN SULFATE, AND PRAMOXINE HYDROCHLORIDEProMex LLC4fa99b96-ab4b-4523-82bc-343dbaf39fb62022-01-25WarningsExact identifier
unii: 19371312D4
Neomycin and Polymyxin B Sulfates and HydrocortisoneNEOMYCIN SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONESandoz Inc96a7b0a5-030a-42dc-80cd-35c4e9aa1b6d2021-08-31Warnings, Adverse reactionsExact identifier
unii: 19371312D4
Neomycin and Polymyxin B Sulfates and HydrocortisoneNEOMYCIN SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONESandoz Inc.99d9030f-9118-412c-a377-d1df1c8fa7232021-08-31Warnings, Adverse reactionsExact identifier
unii: 19371312D4
POLYMYXIN BPOLYMYXIN B SULFATEFresenius Kabi USA, LLC704a41f5-b109-4c16-8d3e-1495c99179522021-05-31Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 204509
unii: 19371312D4
POLYMYXIN BPOLYMYXIN B SULFATEFresenius Kabi USA, LLCfbc12c18-567b-41bc-89d0-efd29616615c2021-02-28Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 204509
unii: 19371312D4
Neomycin and Polymyxin B Sulfates and DexamethasoneNEOMYCIN, POLYMYXIN B SULFATES, DEXAMETHASONEProficient Rx LPbd9f3220-6d42-4863-aa2a-b17b138d095d2021-01-01Warnings, Adverse reactionsExact identifier
unii: 19371312D4

Reported adverse events (FAERS/openFDA)#

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