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 4 of 19 · 366 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Polymyxin B Sulfate and TrimethoprimPOLYMYXIN B SULFATE AND TRIMETHOPRIM SULFATEPreferred Pharmaceuticals Inc.31a7ad1f-3f58-41a0-94f0-36674285bb612026-03-02Adverse reactionsExact identifier
unii: 19371312D4
Neomycin and Polymyxin B Sulfates and HydrocortisoneNEOMYCIN SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONEA-S Medication Solutions1185a82b-e731-456a-8fc1-d9f0fc1ab0bc2026-02-24Warnings, Adverse reactionsExact identifier
unii: 19371312D4
TRIPLE ANTIBIOTIC FIRST AID ANTIBIOTICBACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATENatureplex LLCfbb64891-2219-451d-96b0-e7c0430fadda2026-02-12WarningsExact identifier
unii: 19371312D4
NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDINNEOMYCIN SULFATE, POLYMYXIN B SULFATE AND GRAMICIDINA-S Medication Solutions9691178e-5323-40ce-a8b3-f79e88f027972026-02-04Warnings, Adverse reactionsExact identifier
unii: 19371312D4
Neomycin and Polymyxin B Sulfates and HydrocortisoneNEOMYCIN SULFATE, POLYMYXIN B SULFATE, HYDROCORTISONEA-S Medication Solutions498f34db-89e8-49cc-8543-87da3f4344ec2026-02-04Warnings, Adverse reactionsExact identifier
unii: 19371312D4
Double AntibioticBACITRACIN ZINC AND POLYMYXIN B SULFATESTRATUS PHARMACEUTICALS INCf64b3564-ea3c-4316-8f00-f92c08dcad352026-02-04WarningsExact identifier
unii: 19371312D4
Polymyxin B Sulfate and TrimethoprimPOLYMYXIN B SULFATE AND TRIMETHOPRIM SULFATESportpharm LLC476b8c6d-44e2-47e3-a75c-b4328dfe82a12026-02-03Warnings, Adverse reactionsExact identifier
unii: 19371312D4
Polymyxin B Sulfate and TrimethoprimPOLYMYXIN B SULFATE AND TRIMETHOPRIMA-S Medication Solutionsaaa468d2-470f-43cf-b4e2-68aeb94a1e712026-02-03Warnings, Adverse reactionsExact identifier
unii: 19371312D4
Drs. pharmacy triple antibiotic plus lidocaineBACITRACIN ZINC, POLYMYXIN B SULFATE, NEOMYCIN SULFATE, LIDOCAINE OINTMENTOL PHARMA TECH, LLC49a73b0f-90d9-3a4b-e063-6294a90acfb02026-01-30WarningsExact identifier
unii: 19371312D4
TheraCare Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B, AND PRAMIXINE HCLVeridian Healthcared2374664-4668-4da5-9df7-44e6e421ad542026-01-29WarningsExact identifier
unii: 19371312D4
Equate First Aid Antibiotic Plus Pain ReliefBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDEWalMart907d44c5-cbd1-4d13-8c5c-c164f7a536e52026-01-29WarningsExact identifier
unii: 19371312D4
Natureplex Antibiotic plus PainBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDENatureplex, LLC317acec2-8ab7-4b62-9d72-f98cab4f979c2026-01-29WarningsExact identifier
unii: 19371312D4
Polymyxin B Sulfate and TrimethoprimPOLYMYXIN B SULFATE AND TRIMETHOPRIMREMEDYREPACK INC.2a040ba4-54bd-41e4-b519-01ca6a59658f2026-01-27Warnings, Adverse reactionsExact identifier
unii: 19371312D4
Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE , POLYMYXIN B SULFATE.ProStat First Aid, LLC.4963f926-3d48-36de-e063-6294a90a9acc2026-01-27WarningsExact identifier
unii: 19371312D4
Drs. Pharmacy Triple Antibiotic AND BURN RELIEFBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEOL PHARMA TECH, LLC Drs PHARMACY4928d9dd-542b-fe8b-e063-6294a90a92522026-01-22WarningsExact identifier
unii: 19371312D4
Neomycin and Polymyxin B Sulfates and DexamethasoneNEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND DEXAMETHASONENuCare Pharmaceuticals,Inc.c3b6004a-8cfc-d5f8-e053-2a95a90a3efb2026-01-21Warnings, Adverse reactionsExact identifier
unii: 19371312D4
Neomycin and Polymyxin B Sulfates and DexamethasoneNEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND DEXAMETHASONEPreferred Pharmaceuticals Inc.e42d4837-77c2-40c3-8705-20966a51a8222026-01-19Warnings, Adverse reactionsExact identifier
unii: 19371312D4
Bacitracin Zinc and Polymyxin B SulfateBACITRACIN ZINC AND POLYMYXIN B SULFATEA-S Medication Solutions19b4cfab-5927-47c5-a032-58ab2998d9c72026-01-13Warnings, Adverse reactionsExact identifier
unii: 19371312D4
Neomycin and Polymyxin B Sulfates and HydrocortisoneNEOMYCIN SULFATE, POLYMYXIN B SULFATE, HYDROCORTISONEREMEDYREPACK INC.04fe1b32-adfb-4c36-a986-d81b49497e0f2026-01-12Warnings, Adverse reactionsExact identifier
unii: 19371312D4
Polymyxin B Sulfate and TrimethoprimPOLYMYXIN B SULFATE AND TRIMETHOPRIM SULFATEBausch & Lomb Incorporated87999254-1857-4d3c-817a-cb8f6a5b0cf72026-01-06Warnings, Adverse reactionsExact identifier
unii: 19371312D4

Reported adverse events (FAERS/openFDA)#

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