FDA.reportPublic FDA data

NDC 63323-367-41 - 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
63323-367
Requested NDC
63323-367-41
Package NDCs from labels
63323-367-41, 63323-367-44, 63323-367-01, 63323-367-11
Manufacturer
Fresenius Kabi USA, LLC | Gland Pharma Limited
Effective date
2022-12-01
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, LLC | Gland Pharma LimitedFresenius Kabi USA, LLC | Gland Pharma Limited2022-12-01HUMAN PRESCRIPTION DRUG LABEL
POLYMYXIN B - Fresenius Kabi USA, LLC | Xellia Pharmaceuticals ApS | Gland Pharma LimitedFresenius Kabi USA, LLC | Xellia Pharmaceuticals ApS | Gland Pharma Limited2020-10-28HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63323-367-41Polymyxin B1 in 1 VIAL, GLASSINJECTION, POWDER, LYOPHILIZED,12
63323-367-44Polymyxin B10 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63323-367POLYMYXIN B (POLYMYXIN B SULFATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC]2Current NDC, Legacy NDC, 2 package rows20221203_72dd6de6-31d6-4a8f-881b-91af91ed9314.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63323-367-01EA - Each63323-367d2629dfb-66d3-4025-9576-9851047e7c7512021-12-08
63323-367-11EA - Each63323-3670edc63fe-5024-4464-b4b5-8765acd8701612016-01-13
63323-367-41EA - Each63323-36785470c03-85be-4e3c-a026-027e0c8a3baa12019-09-05
63323-367-44EA - Each63323-367e6354b22-e52e-4962-8b65-b7bab0ec021712019-09-05

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]1
POLYMYXIN BACTIVE MOIETYJ2VZ07J96KPOLYMYXIN B (POLYMYXIN B SULFATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC]1

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 · 367 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Neomycin and Polymyxin B Sulfates and DexamethasoneNEOMYCIN, POLYMYXIN B SULFATES, DEXAMETHASONEProficient Rx LPbd9f3220-6d42-4863-aa2a-b17b138d095d2021-01-01Warnings, Adverse reactionsExact identifier
unii: 19371312D4
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.