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 18 of 19 · 366 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EVERLIT CARE Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATENantong Health & Beyond Hygienic Products Inc.f4921508-c32f-426f-a2f0-16c3acbd47132023-10-14WarningsExact identifier
unii: 19371312D4
MAXITROLNEOMYCIN SULFATE, POLYMYXIN B SULFATE AND DEXAMETHASONENovartis Pharmaceuticals Corporation22c6d2db-85af-4a3b-a014-80d901a867172023-06-27Warnings, Adverse reactionsExact identifier
unii: 19371312D4
Bactine Max Antibiotic and Lidocaine Max Pain ReliefLIDOCAINEWellSpring Pharmaceutical Corporation71300df9-6113-4f25-93ca-28ad7e7f79de2023-06-08WarningsExact identifier
unii: 19371312D4
Neomycin and Polymyxin B Sulfates and DexamethasoneNEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND DEXAMETHASONEBausch & Lomb Incorporated4456d10b-9995-4430-b692-a8859ea36deb2023-06-01Warnings, Adverse reactionsExact identifier
unii: 19371312D4
Neomycin and Polymyxin B Sulfates and DexamethasoneNEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND DEXAMETHASONEProficient Rx LP21c9b34c-af88-4c9e-9b6c-32d78d34ba7e2023-05-01Warnings, Adverse reactionsExact identifier
unii: 19371312D4
Neomycin and Polymyxin B Sulfates and Hydrocortisone Otic SuspensionNEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE OTICA-S Medication Solutionsc895676f-446a-4a93-a3d2-addcce96b1082023-01-23Warnings, Adverse reactionsExact identifier
unii: 19371312D4
Polymyxin BPOLYMYXIN B SULFATEFresenius Kabi USA, LLC72dd6de6-31d6-4a8f-881b-91af91ed93142022-12-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 204509
unii: 19371312D4
Neomycin Polymyxin B Sulfates and DexamethasoneNEOMYCIN SULFATE, POLYMYXIN B SULFATE AND DEXAMETHASONEProficient Rx LP548089f3-29d8-4ba8-af21-9e04356ac29c2022-10-01Warnings, Adverse reactionsExact identifier
unii: 19371312D4
Neomycin and Polymyxin B Sulfates and HydrocortisoneNEOMYCIN SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONEProficient Rx LPf5ef71ae-fca9-4a57-ae88-f2b2d195a1792022-08-01Warnings, Adverse reactionsExact identifier
unii: 19371312D4
Neomycin and Polymyxin B Sulfates and HydrocortisoneNEOMYCIN SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONEProficient Rx LP98042cef-2839-49d6-a7bd-a1d29c74430b2022-05-02Warnings, Adverse reactionsExact identifier
unii: 19371312D4
Neomycin and Polymyxin B Sulfates and HydrocortisoneNEOMYCIN SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONEProficient Rx LP601cab21-c211-4c34-be7b-f4fdd97a921a2022-05-02Warnings, Adverse reactionsExact identifier
unii: 19371312D4
Polymyxin BPOLYMYXIN B SULFATEHikma Pharmaceuticals USA Inc.18daf0d1-b6f5-46f4-ab2f-01a594f3959c2022-04-28Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 204509
unii: 19371312D4
Polymyxin B Sulfate and TrimethoprimPOLYMYXIN B SULFATE AND TRIMETHOPRIMProficient Rx LP1252b997-3a81-4f3c-90e4-92f29ba157132022-04-01Warnings, Adverse reactionsExact identifier
unii: 19371312D4
Polymyxin B Sulfate and TrimethoprimPOLYMYXIN B SULFATE AND TRIMETHOPRIM SULFATEProficient Rx LPd1f55327-156f-44cd-b0fc-b1a938e8aa732022-04-01Warnings, Adverse reactionsExact identifier
unii: 19371312D4
CuadridermaBACITRACIN ZINC, POLYMYXIN B SULFATE, NEOMYCIN SULFATE, AND PRAMOXINE HYDROCHLORIDEProMex LLC4fa99b96-ab4b-4523-82bc-343dbaf39fb62022-01-25WarningsExact identifier
unii: 19371312D4
Neomycin and Polymyxin B Sulfates and HydrocortisoneNEOMYCIN SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONESandoz Inc96a7b0a5-030a-42dc-80cd-35c4e9aa1b6d2021-08-31Warnings, Adverse reactionsExact identifier
unii: 19371312D4
Neomycin and Polymyxin B Sulfates and HydrocortisoneNEOMYCIN SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONESandoz Inc.99d9030f-9118-412c-a377-d1df1c8fa7232021-08-31Warnings, Adverse reactionsExact identifier
unii: 19371312D4
POLYMYXIN BPOLYMYXIN B SULFATEFresenius Kabi USA, LLC704a41f5-b109-4c16-8d3e-1495c99179522021-05-31Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA065372
ndc (package): 63323-321-02
ndc (package): 63323-321-12
ndc (product): 63323-321
rxcui: 204509
spl id: b473292e-e7ce-4ce2-aec7-91604b82bb11
spl set id: 704a41f5-b109-4c16-8d3e-1495c9917952
unii: 19371312D4
POLYMYXIN BPOLYMYXIN B SULFATEFresenius Kabi USA, LLCfbc12c18-567b-41bc-89d0-efd29616615c2021-02-28Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA065372
ndc (package): 63323-321-01
ndc (package): 63323-321-10
ndc (product): 63323-321
ndc11 (package): 63323032101
rxcui: 204509
spl id: 545b3d1d-6c8f-44aa-b81e-b24fc99f9c82
spl set id: fbc12c18-567b-41bc-89d0-efd29616615c
unii: 19371312D4
Neomycin and Polymyxin B Sulfates and DexamethasoneNEOMYCIN, POLYMYXIN B SULFATES, DEXAMETHASONEProficient Rx LPbd9f3220-6d42-4863-aa2a-b17b138d095d2021-01-01Warnings, Adverse reactionsExact identifier
unii: 19371312D4

Reported adverse events (FAERS/openFDA)#

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