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 9 of 19 · 367 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Meret Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATENantong Health & Beyond Hygienic Products Inc.385d8642-9eae-a750-e063-6394a90a79312025-06-24WarningsExact identifier
unii: 19371312D4
ProCure Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATETwin Med LLC37a3916f-cc1a-41a0-e063-6394a90a35ed2025-06-16WarningsExact identifier
unii: 19371312D4
Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, POLYMYXIN BJ&A Digital Inc.9b8f2046-5886-440d-a7fc-a71138d7f34b2025-06-02WarningsExact identifier
unii: 19371312D4
POLYMYXIN BPOLYMYXIN B SULFATEFOSUN PHARMA USA INCfd664927-db58-a1af-e053-6294a90a90482025-05-29Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 204509
unii: 19371312D4
Polymyxin BPOLYMYXIN B SULFATEHikma Pharmaceuticals USA Inc.d2bf65f6-2763-4859-a665-ad5e6cde71ee2025-05-23Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA202766
rxcui: 204509
unii: 19371312D4
SionBiotext Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATESion Biotext Medical Ltd35083d42-5823-eeb1-e063-6294a90acafa2025-05-13WarningsExact identifier
unii: 19371312D4
Multi ActionBACITRACINZINC,NEOMYCINSULFATE,POLYMYXINBSULFATE,PRAMOXINEHCLTrifecta Pharmaceutical USA LLCb98082f3-be95-49fb-e053-2a95a90a37b82025-05-13WarningsExact identifier
unii: 19371312D4
Leader Triple antibiotic and pain reliefBACITRACIN,NEOMYCIN,POLYMXIN, PRAMOXINECardinal Health 110 dba LEADERf4c521d9-dd05-1c23-e053-2995a90a6e2c2025-05-13WarningsExact identifier
unii: 19371312D4
TripleantibioticointmentandpainreliefBACITRACIN,NEOMYCIN,POLYMXIN, PRAMOXINETrifecta Pharmaceuticals USA34f1db74-6506-d53d-e063-6394a90ac4002025-05-12WarningsExact identifier
unii: 19371312D4
Polymyxin BPOLYMYXIN BEugia US LLCa974c557-e88f-451b-a1bd-d2c656be226e2025-05-09Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 204509
unii: 19371312D4
POLYMYXIN BPOLYMYXIN B SULFATEGland Pharma Limiteddc74dee2-1d0b-4fab-a29b-1755fdb5da752025-05-09Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 204509
unii: 19371312D4
Neomycin and Polymyxin B Sulfates and HydrocortisoneNEOMYCIN SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONEBausch & Lomb Incorporatedb0ee85dd-5fe1-46a3-9bff-606e489d20b12025-04-30Warnings, Adverse reactionsExact identifier
unii: 19371312D4
Triple Antibiotic plus LidocaineBACITRACIN ZINC, NEOMYCIN SULFATE , POLYMYXIN B SULFATE, LIDOCAINETRIFECTA PHARMACEUTICALS USA LLC14fda967-54ba-c964-e063-6294a90a21ee2025-04-24WarningsExact identifier
unii: 19371312D4
NEOMYCIN POLYMYXIN B SULFATES AND DEXAMETHASONENEOMYCIN SULFATE, POLYMYXIN B SULFATE AND DEXAMETHASONE SUSPENSION/ DROPSDirectRxd5e00bad-abb4-63ad-e053-2a95a90a5abb2025-04-15Warnings, Adverse reactionsExact identifier
unii: 19371312D4
Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE , POLYMYXIN B SULFATE.Front Pharmaceutical PLC3244d91e-6c6b-a351-e063-6294a90aa02d2025-04-08WarningsExact identifier
unii: 19371312D4
Redicare Triple Antibiotic First AidTRIPLE ANTIBIOTIC FIRST AID OINTMENTRedicare LLC9468979d-446e-e4be-e053-2995a90a3f212025-03-05WarningsExact identifier
unii: 19371312D4
Neomycin and Polymyxin B Sulfates and DexamethasoneNEOMYCIN SULFATE, POLYMYXIN B SULFATE AND DEXAMETHASONESandoz Inc.cf1a6da8-ba79-4bff-a13b-6effb67f6c1c2025-02-20Warnings, Adverse reactionsExact identifier
unii: 19371312D4
The Life Safety Pro Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATENantong Health & Beyond Hygienic Products Inc.64a7331f-98a6-4052-85b9-695c83b3bd162025-02-19WarningsExact identifier
unii: 19371312D4
Sheffield Triple AntibioticBACITRACIN ZINC, POLYMYXIN B SULFATE, NEOMYCIN SULFATESheffield Pharmaceuticals LLC1aa95046-c1f7-4fc7-acac-839065d998f62025-02-17WarningsExact identifier
unii: 19371312D4
Polymyxin B Sulfate and TrimethoprimPOLYMYXIN B SULFATE AND TRIMETHOPRIM SULFATENuCare Pharmaceuticals,Inc.55e1f68a-836b-5c23-e054-00144ff88e882025-02-06Warnings, Adverse reactionsExact identifier
unii: 19371312D4

Reported adverse events (FAERS/openFDA)#

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