FDA.reportPublic FDA data

NDC 63323-321-01 - 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
63323-321
Requested NDC
63323-321-01
Package NDCs from labels
63323-321-02, 63323-321-12, 63323-321-01, 63323-321-10
Manufacturer
Fresenius Kabi USA, LLC
Effective date
2021-05-31
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
POLYMYXIN B - Fresenius Kabi USA, LLCFresenius Kabi USA, LLC2021-05-31HUMAN PRESCRIPTION DRUG LABEL
POLYMYXIN B - Fresenius Kabi USA, LLCFresenius Kabi USA, LLC2021-02-28HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63323-321-01POLYMYXIN B1 in 1 VIALINJECTION, POWDER, LYOPHILIZED,14
63323-321-10POLYMYXIN B10 in 1 TRAYINJECTION, POWDER, LYOPHILIZED,104
63323-321-02POLYMYXIN B1 in 1 VIALINJECTION, POWDER, LYOPHILIZED,11
63323-321-12POLYMYXIN B10 in 1 TRAYINJECTION, POWDER, LYOPHILIZED,101

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63323-321POLYMYXIN B (POLYMYXIN B SULFATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC ]4Current NDC, Legacy NDC, 2 package rows20210319_fbc12c18-567b-41bc-89d0-efd29616615c.zip
63323-321POLYMYXIN B (POLYMYXIN B SULFATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC ]1Current NDC, Legacy NDC, 2 package rows20210610_704a41f5-b109-4c16-8d3e-1495c9917952.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63323-321-01EA - Each63323-321be16a189-5df5-47a8-b45a-cdb1b65a94c312021-12-08
63323-321-02EA - Each63323-321bfda5fd4-1a9f-4670-9011-10eec3ecb30f12021-12-08
63323-321-10EA - Each63323-32139fc3b1f-87de-48e0-876a-de660dbc6b0b12012-07-24
63323-321-12EA - Each63323-321b3ba8ab7-008d-430e-a375-60326f0daeb812021-12-08

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
POLYMYXIN B SULFATEACTIVE INGREDIENT19371312D4POLYMYXIN B (POLYMYXIN B SULFATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC]2
POLYMYXIN BACTIVE MOIETYJ2VZ07J96KPOLYMYXIN B (POLYMYXIN B SULFATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC]2

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 16 of 19 · 366 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Triple Antibiotic with Pain ReliefBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, PRAMOXINE HYDROCHLORIDESafetec of America, Inc.ca1df4a0-844d-4b1d-b972-f2704a8ebbab2024-02-16WarningsExact identifier
unii: 19371312D4
Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATESafetec of America, Inc.96c41fc1-81f9-4757-abc6-867b5383ed5d2024-02-07WarningsExact identifier
unii: 19371312D4
Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATESafetec of America, Inc.2c2aa8af-2adb-4f59-ac20-15818d0e28e72024-02-07WarningsExact identifier
unii: 19371312D4
Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATESafetec of America, Inc.03c05028-5a5f-4690-a836-cc1b1044ab392024-02-05WarningsExact identifier
unii: 19371312D4
Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATESafetec of America, Inc.59494d5c-dd8a-431c-8e6a-4e1151ba74602024-02-05WarningsExact identifier
unii: 19371312D4
Triple AntibioticFIRST AID ANTIBIOTICBluePoint Laboratoriesc47e15bd-1062-4cca-e053-2995a90a90752024-01-31WarningsExact identifier
unii: 19371312D4
Antibiotic and Pain ReliefNEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDETarget Corporation050be94c-1fbb-4d84-82c6-841aac8f318e2024-01-18WarningsExact identifier
unii: 19371312D4
Leader Triple AntibioticFIRST AID TRIPLE ANTIBIOTICCardinal Health 110,Inc.844cd9a1-b68e-47d8-a5eb-c9e880ba019e2024-01-18WarningsExact identifier
unii: 19371312D4
Multi-Action Antibiotic and Pain ReliefBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE OINTMENTTarget Corporation8fecff32-bd67-4351-90f7-0c28cb335ea32024-01-18WarningsExact identifier
unii: 19371312D4
TRIBIOTICBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEHART Healthd8f175f9-f526-4c73-a171-49309ca16cb02024-01-18Warnings, Adverse reactionsExact identifier
unii: 19371312D4
Leader Poly BacitracinFIRST AID ANTIBIOTICCardinal Health 110, Inc.442e11aa-7d14-44f9-bf14-446018f1de0d2024-01-18WarningsExact identifier
unii: 19371312D4
Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEUnifirst First Aid Corporation7b16cb9b-5847-4360-9974-2118f4a2c70f2024-01-17WarningsExact identifier
unii: 19371312D4
Green Guard Triple AntibioticBACITRACIN ZIN, NEOMYCIN SULFATE, POLYMYXIN B SULFATEUnifirst First Aid Corporationbd456e2f-e6d7-d2ad-e053-2995a90a5c122024-01-17WarningsExact identifier
unii: 19371312D4
Medi-First Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEUnifirst First Aid Corporationbd432abc-fefb-1b4b-e053-2995a90acb182024-01-17WarningsExact identifier
unii: 19371312D4
Crane Safety Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATECrane Safety LLC96dbc282-4b3f-aaf3-e053-2995a90a56942024-01-17WarningsExact identifier
unii: 19371312D4
Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATETarget Corporation10c4a1b5-bb91-48da-b0ae-303e4adf793a2024-01-17WarningsExact identifier
unii: 19371312D4
Triple Antibiotic and Pain ReliefTRIPLE ANTIBIOTICTarget Corporation8fda7b8a-72f3-4b92-a229-ac5be0e3b3eb2024-01-17WarningsExact identifier
unii: 19371312D4
MyMedic Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATENantong Health & Beyond Hygienic Products Inc.0f0d1ba7-fe9c-8e0b-e063-6394a90a30812024-01-16WarningsExact identifier
unii: 19371312D4
Travel Savvy First Aid Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEBellegrove Medical Supply, Inc.69fa1c9d-5e6d-4593-e053-2a91aa0a76902024-01-16WarningsExact identifier
unii: 19371312D4
Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATESled Distribution, LLCe7398df8-8e23-5439-e053-2a95a90ac3aa2024-01-15WarningsExact identifier
unii: 19371312D4

Reported adverse events (FAERS/openFDA)#

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