FDA.reportPublic FDA data

NDC 0143-9941-01 - 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
0143-9941
Requested NDC
0143-9941-01
Package NDCs from labels
0143-9941-01, 0143-9941-10
Manufacturer
Hikma Pharmaceuticals USA Inc.
Effective date
2022-04-28
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Polymyxin B for Injection, USPHikma Pharmaceuticals USA Inc.2022-04-28HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0143-9941-01Polymyxin B1 in 1 VIALINJECTION, POWDER, FOR SOLUTION13
0143-9941-10Polymyxin B10 in 1 CARTONINJECTION, POWDER, FOR SOLUTION103

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0143-9941POLYMYXIN B (POLYMYXIN B SULFATE) INJECTION, POWDER, FOR SOLUTION [HIKMA PHARMACEUTICALS USA INC.]3Current NDC, Legacy NDC, 2 package rows20220429_18daf0d1-b6f5-46f4-ab2f-01a594f3959c.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 19 of 19 · 366 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Trimethoprim sulfate and Polymyxin B sulfateTRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATEProficient Rx LP2c5579eb-ad81-415e-8dcb-9f1c94c897ae2021-01-01Warnings, Adverse reactionsExact identifier
unii: 19371312D4
Neomycin and Polymyxin B Sulfates and HydrocortisoneNEOMYCIN SULFATE, POLYMYXIN B SULFATE, HYDROCORTISONEProficient Rx LPd55f1783-9c49-4f90-9ff8-6f132e7b325e2021-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 19371312D4
Neomycin and Polymyxin B Sulfates and DexamethasoneNEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONEProficient Rx LPaa7b8a3f-06dd-4190-96a5-f86195bd21972021-01-01Warnings, Adverse reactionsExact identifier
unii: 19371312D4
Neomycin and Polymyxin B Sulfates and HydrocortisoneNEOMYCIN SULFATE, POLYMYXIN B SULFATE, HYDROCORTISONEAsclemed USA, Inc.7c78ec84-8b7c-42f1-a879-3bf27a1daa712020-10-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 19371312D4
Water-Jel 3-in-1 AntibioticBACITRACIN ZINC, POLYMYXIN B SULFATE, NEOMYCIN SULFATEWater-Jel Technologiesd5fcaffd-af38-4285-a79c-6df7424c76fa2017-11-16WarningsExact identifier
unii: 19371312D4
CVS Triple AntibioticBACITRACIN, NEOMYCIN, POLYMYXIN BCVS Pharmacy454bfeed-f58f-003a-e054-00144ff8d46c2017-01-04WarningsExact identifier
unii: 19371312D4

Reported adverse events (FAERS/openFDA)#

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