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 17 of 19 · 366 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Neomycin and Polymyxin B Sulfates and HydrocortisoneNEOMYCIN SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONEBryant Ranch Prepack7a8e4f05-60f3-4492-a204-f26a251d8f652024-01-15Warnings, Adverse reactionsExact identifier
unii: 19371312D4
Neo/Poly-B/Dex Ophth OintNEO/POLY-B/DEX OPHTH OINTDirect_Rx0ec1dfdf-b63f-fb0c-e063-6294a90a843d2024-01-12Warnings, Adverse reactionsExact identifier
unii: 19371312D4
ER Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEEVER READY FIRST AID20f97e1c-584f-4844-afd8-8641ffe2f4662024-01-11WarningsExact identifier
unii: 19371312D4
Lightning X Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATENantong Health & Beyond Hygienic Products Inc.0e66af91-e0b4-827f-e063-6294a90a98472024-01-07WarningsExact identifier
unii: 19371312D4
triple antibiotic 01BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATECosmuses Cosmetics (Ningbo) Co., Ltd.0e1b23f3-fa1e-f42b-e063-6394a90a3bec2024-01-04WarningsExact identifier
unii: 19371312D4
Triple Antibiotic Ointment, Circle KTRIPLE ANTIBIOTICLil' Drug Store products, Inc.0d98477b-aa33-ebb7-e063-6294a90a597f2024-01-03WarningsExact identifier
unii: 19371312D4
Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE , POLYMYXIN B SULFATE.Geri-Care Pharmaceuticals, Corpef309620-1cf9-d007-e053-2995a90ad46f2024-01-02WarningsExact identifier
unii: 19371312D4
Triple AntibioticPOLYMYXIN B SULFATE, BACITRACIN ZINC AND NEOMYCIN SULFATENuCare Pharmaceuticals,Inc.0dfe5f6a-6968-68e6-e063-6294a90ae25b2024-01-02WarningsExact identifier
unii: 19371312D4
TRIPLE ANTIBIOTICBACITRACIN ZINC NEOMYCIN SULFATE POLYMYXIN B SULFATEProficient Rx LP949c5b44-ee52-4913-8872-39181d3199982024-01-01WarningsExact identifier
unii: 19371312D4
MAXITROLNEOMYCIN SULFATE, POLYMYXIN B SULFATE AND DEXAMETHASONESandoz Inc5776c435-ac60-49b6-8db1-23a3012b91552023-12-29Warnings, Adverse reactionsExact identifier
unii: 19371312D4
Triple Antibiotic PlusPOLYMYXIN B SULFATE, BACITRACIN ZINC, NEOMYCIN SULFATE, PRAMOXINE HCLCosette Pharmaceuticals, Inc.69d911c2-cb89-2241-35f8-c83acfe182492023-12-21WarningsExact identifier
unii: 19371312D4
Triple AntibioticPOLYMYXIN B SULFATE, BACITRACIN ZINC AND NEOMYCIN SULFATECosette Pharmaceuticals, Inc.39893365-c94f-bc83-67f6-0005d5f2aa242023-12-20WarningsExact identifier
unii: 19371312D4
Triple AntibioticPOLYMYXIN B SULFATE, BACITRACIN ZINC AND NEOMYCIN SULFATEProficient Rx LP524d65e7-9dc6-47b0-a924-46a765fa18692023-12-01WarningsExact identifier
unii: 19371312D4
Genuine First Aid AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEGFA Production(Xiamen) Co.,Ltd0aaee474-cf35-8b39-e063-6294a90a815c2023-11-21WarningsExact identifier
unii: 19371312D4
Sheffield Triple Antibiotic Plus Pain ReliefBACITRACIN ZINC, POLYMYXIN B SULFATE, NEOMYCIN SULFATE, PRAMOXINE HYDROCHLORIDESheffield Pharmaceuticals LLC485a779c-017b-4064-a446-e5073c1bdb072023-11-20WarningsExact identifier
unii: 19371312D4
EVERLIT CARE Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEEVERLIT GLOBAL INC.e9157891-fc05-41a1-8a86-761a9ae56f8a2023-11-14WarningsExact identifier
unii: 19371312D4
Neomycin and Polymyxin B Sulfates and DexamethasoneNEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND DEXAMETHASONEA-S Medication Solutions0d273133-0ce9-4fe6-b873-7f85aac254862023-11-01Warnings, Adverse reactionsExact identifier
unii: 19371312D4
Family wellnessBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEFRONT PHARMACEUTICAL PLCbd3b8146-6271-488d-bf79-0bb659123b312023-10-27WarningsExact identifier
unii: 19371312D4
Family Wellness Antiseptic and Pain ReliefBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, PRAMOXINE HYDROCHLORIDEFRONT PHARMACEUTICAL PLCcb7fdcde-2bd8-4834-ba4e-4d6fd15125992023-10-26WarningsExact identifier
unii: 19371312D4
GENUINE FIRST AID AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATENantong Health & Beyond Hygienic Products Inc.23abfe12-5b50-4b49-878e-4fcdb6c341fd2023-10-19WarningsExact identifier
unii: 19371312D4

Reported adverse events (FAERS/openFDA)#

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