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 3 of 19 · 366 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
First Aid AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEHubei Fanjian Medical Product Co.,Ltdf44ab989-c618-1831-e053-2995a90adc8e2026-05-28WarningsExact identifier
unii: 19371312D4
TRIBIOTICBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEHART Health3d17aba0-220f-42c4-9e26-5c44857847cd2026-05-20Warnings, Adverse reactionsExact identifier
unii: 19371312D4
triple antibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEWalgreens Co.32df5cca-77bc-45d2-b1f6-2cfdfc371ea92026-05-12WarningsExact identifier
unii: 19371312D4
ANTIBIOTIC Maximum StrengthBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEWalgreens Co.653c88bf-5b7d-45be-a131-d59990573e9c2026-05-12WarningsExact identifier
unii: 19371312D4
Harris Teeter Triple Antibiotic and Pain ReliefNEOMYCIN SULFATE, POLYMYXIN B SULFATE, BACITRACIN ZINC, PRAMOXINE HCLHARRIS TEETER LLC4b0c0a3c-7145-97ca-e063-6394a90a1a962026-05-07WarningsExact identifier
unii: 19371312D4
Harris Teeter Triple AntibioticNEOMYCIN SULFATE, POLYMYXIN B SULFATE, BACITRACIN ZINCHARRIS TEETER LLC4e81590c-32d3-f8aa-e063-6294a90ab3412026-05-06WarningsExact identifier
unii: 19371312D4
FIRSTAR TRIPLE ANTIBIOTICBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATENantong Health & Beyond Hygienic Products Inc.5b9434ad-83d7-4df3-bfef-3db152e6c6cc2026-05-04WarningsExact identifier
unii: 19371312D4
oopsie First AidBACITRACIN ZINC NEOMYCIN SULFATE POLYMYXIN B SULFATE4 Visions LLC50b21f0a-1e87-51ae-e063-6294a90a8a3c2026-04-30WarningsExact identifier
unii: 19371312D4
Family Care Antibiotic Pain Relief 0.33ozANTIBIOTIC PAIN RELIEFUnited Exchange Corp4f8405fc-3e38-05d9-e063-6394a90a4cda2026-04-15WarningsExact identifier
unii: 19371312D4
Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE , POLYMYXIN B SULFATE.TRIFECTA PHARMACEUTICALS USA LLC23a35ba8-ebc6-4252-bb88-ec237425056c2026-04-15WarningsExact identifier
unii: 19371312D4
Family Care Triple Antibiotic Original Formula 0.33ozTRIPLE ANTIBIOTIC ORIGINAL FORMULAUnited Exchange Corp4f1ef127-a67e-ca60-e063-6394a90a3a3d2026-04-10WarningsExact identifier
unii: 19371312D4
Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B, PRAMOXINE HYDROCHLORIDEH E B2a143950-13b4-457e-91a4-c61a88aad84b2026-04-02WarningsExact identifier
unii: 19371312D4
Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE , POLYMYXIN B SULFATE.ProStat First Aid, LLC.4e54f479-ad87-e86b-e063-6394a90aa6d22026-03-31WarningsExact identifier
unii: 19371312D4
Antibiotic and Pain ReliefNEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDESTRATEGIC SOURCING SERVICES LLCf7aa9330-c47c-4d2f-b784-11b831d919d62026-03-18WarningsExact identifier
unii: 19371312D4
Neomycin and Polymyxin B SulfatesNEOMYCIN AND POLYMYXIN B SULFATESXGen Pharmaceuticals DJB, Inc.a2f47d77-efd3-4c84-a364-08fb6d9978eb2026-03-18Warnings, Adverse reactionsExact identifier
unii: 19371312D4
Bacitracin Zinc and Polymyxin B SulfateBACITRACIN ZINC AND POLYMYXIN B SULFATEA-S Medication Solutions51f6eac3-205e-4beb-8522-6ba2c593f3502026-03-17Warnings, Adverse reactionsExact identifier
unii: 19371312D4
Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE , POLYMYXIN B SULFATE.ProStat First Aid, LLC.4cd49c65-e347-7589-e063-6394a90a53bd2026-03-12WarningsExact identifier
unii: 19371312D4
Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE , POLYMYXIN B SULFATE.ProStat First Aid, LLC.4cc6d822-f383-2ceb-e063-6294a90aecc72026-03-11WarningsExact identifier
unii: 19371312D4
Ora Zen Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEOrazen Incabbf8c34-87cb-4366-9840-7264a5114b542026-03-11WarningsExact identifier
unii: 19371312D4
doubleantibioticointmentBACITRACIN ZINC, POLYMYXIN B SULFATETrifecta Pharmaceuticals USA LLC4eb5202e-8e5b-6d31-e054-00144ff88e882026-03-04WarningsExact identifier
unii: 19371312D4

Reported adverse events (FAERS/openFDA)#

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