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
Label	Manufacturer	Effective date	Type
Polymyxin B - Fresenius Kabi USA, LLC \| Gland Pharma Limited	Fresenius Kabi USA, LLC \| Gland Pharma Limited	2022-12-01	HUMAN PRESCRIPTION DRUG LABEL
POLYMYXIN B - Fresenius Kabi USA, LLC \| Xellia Pharmaceuticals ApS \| Gland Pharma Limited	Fresenius Kabi USA, LLC \| Xellia Pharmaceuticals ApS \| Gland Pharma Limited	2020-10-28	HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
63323-367-41	Polymyxin B	1 in 1 VIAL, GLASS	INJECTION, POWDER, LYOPHILIZED,	1		2
63323-367-44	Polymyxin B	10 in 1 CARTON	INJECTION, POWDER, LYOPHILIZED,	10		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63323-367	POLYMYXIN B (POLYMYXIN B SULFATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC]	2	Current NDC, Legacy NDC, 2 package rows	20221203_72dd6de6-31d6-4a8f-881b-91af91ed9314.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63323-367-01	EA - Each	63323-367	d2629dfb-66d3-4025-9576-9851047e7c75	1	2021-12-08
63323-367-11	EA - Each	63323-367	0edc63fe-5024-4464-b4b5-8765acd87016	1	2016-01-13
63323-367-41	EA - Each	63323-367	85470c03-85be-4e3c-a026-027e0c8a3baa	1	2019-09-05
63323-367-44	EA - Each	63323-367	e6354b22-e52e-4962-8b65-b7bab0ec0217	1	2019-09-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version	Uploaded
POLYMYXIN B SULFATE	ACTIVE INGREDIENT	19371312D4	POLYMYXIN B (POLYMYXIN B SULFATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC]	1
POLYMYXIN B	ACTIVE MOIETY	J2VZ07J96K	POLYMYXIN 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 18 of 19 · 367 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
EVERLIT CARE Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	Nantong Health & Beyond Hygienic Products Inc.	f4921508-c32f-426f-a2f0-16c3acbd4713	2023-10-14	Warnings	Exact identifier unii: 19371312D4
MAXITROL	NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND DEXAMETHASONE	Novartis Pharmaceuticals Corporation	22c6d2db-85af-4a3b-a014-80d901a86717	2023-06-27	Warnings, Adverse reactions	Exact identifier unii: 19371312D4
Bactine Max Antibiotic and Lidocaine Max Pain Relief	LIDOCAINE	WellSpring Pharmaceutical Corporation	71300df9-6113-4f25-93ca-28ad7e7f79de	2023-06-08	Warnings	Exact identifier unii: 19371312D4
Neomycin and Polymyxin B Sulfates and Dexamethasone	NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND DEXAMETHASONE	Bausch & Lomb Incorporated	4456d10b-9995-4430-b692-a8859ea36deb	2023-06-01	Warnings, Adverse reactions	Exact identifier unii: 19371312D4
Neomycin and Polymyxin B Sulfates and Dexamethasone	NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND DEXAMETHASONE	Proficient Rx LP	21c9b34c-af88-4c9e-9b6c-32d78d34ba7e	2023-05-01	Warnings, Adverse reactions	Exact identifier unii: 19371312D4
79859129-5e1a-493c-b8f1-02ebd2fc065b			1d57c007-5019-4f88-a927-4a186c25d912	2023-04-11	Boxed warning, Warnings, Adverse reactions	Exact identifier spl set id: 1d57c007-5019-4f88-a927-4a186c25d912
Neomycin and Polymyxin B Sulfates and Hydrocortisone Otic Suspension	NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE OTIC	A-S Medication Solutions	c895676f-446a-4a93-a3d2-addcce96b108	2023-01-23	Warnings, Adverse reactions	Exact identifier unii: 19371312D4
Polymyxin B	POLYMYXIN B SULFATE	Fresenius Kabi USA, LLC	72dd6de6-31d6-4a8f-881b-91af91ed9314	2022-12-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application number: ANDA202766 ndc (package): 63323-367-44 ndc (package): 63323-367-41 ndc (product): 63323-367 ndc11 (package): 63323036741 rxcui: 204509 spl id: 5cf9b65b-6df4-42f8-b395-d0cf0a1003d3 spl set id: 72dd6de6-31d6-4a8f-881b-91af91ed9314 unii: 19371312D4
Neomycin Polymyxin B Sulfates and Dexamethasone	NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND DEXAMETHASONE	Proficient Rx LP	548089f3-29d8-4ba8-af21-9e04356ac29c	2022-10-01	Warnings, Adverse reactions	Exact identifier unii: 19371312D4
Neomycin and Polymyxin B Sulfates and Hydrocortisone	NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONE	Proficient Rx LP	f5ef71ae-fca9-4a57-ae88-f2b2d195a179	2022-08-01	Warnings, Adverse reactions	Exact identifier unii: 19371312D4
Neomycin and Polymyxin B Sulfates and Hydrocortisone	NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONE	Proficient Rx LP	98042cef-2839-49d6-a7bd-a1d29c74430b	2022-05-02	Warnings, Adverse reactions	Exact identifier unii: 19371312D4
Neomycin and Polymyxin B Sulfates and Hydrocortisone	NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONE	Proficient Rx LP	601cab21-c211-4c34-be7b-f4fdd97a921a	2022-05-02	Warnings, Adverse reactions	Exact identifier unii: 19371312D4
Polymyxin B	POLYMYXIN B SULFATE	Hikma Pharmaceuticals USA Inc.	18daf0d1-b6f5-46f4-ab2f-01a594f3959c	2022-04-28	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 204509 unii: 19371312D4
Polymyxin B Sulfate and Trimethoprim	POLYMYXIN B SULFATE AND TRIMETHOPRIM	Proficient Rx LP	1252b997-3a81-4f3c-90e4-92f29ba15713	2022-04-01	Warnings, Adverse reactions	Exact identifier unii: 19371312D4
Polymyxin B Sulfate and Trimethoprim	POLYMYXIN B SULFATE AND TRIMETHOPRIM SULFATE	Proficient Rx LP	d1f55327-156f-44cd-b0fc-b1a938e8aa73	2022-04-01	Warnings, Adverse reactions	Exact identifier unii: 19371312D4
Cuadriderma	BACITRACIN ZINC, POLYMYXIN B SULFATE, NEOMYCIN SULFATE, AND PRAMOXINE HYDROCHLORIDE	ProMex LLC	4fa99b96-ab4b-4523-82bc-343dbaf39fb6	2022-01-25	Warnings	Exact identifier unii: 19371312D4
Neomycin and Polymyxin B Sulfates and Hydrocortisone	NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONE	Sandoz Inc	96a7b0a5-030a-42dc-80cd-35c4e9aa1b6d	2021-08-31	Warnings, Adverse reactions	Exact identifier unii: 19371312D4
Neomycin and Polymyxin B Sulfates and Hydrocortisone	NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONE	Sandoz Inc.	99d9030f-9118-412c-a377-d1df1c8fa723	2021-08-31	Warnings, Adverse reactions	Exact identifier unii: 19371312D4
POLYMYXIN B	POLYMYXIN B SULFATE	Fresenius Kabi USA, LLC	704a41f5-b109-4c16-8d3e-1495c9917952	2021-05-31	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 204509 unii: 19371312D4
POLYMYXIN B	POLYMYXIN B SULFATE	Fresenius Kabi USA, LLC	fbc12c18-567b-41bc-89d0-efd29616615c	2021-02-28	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 204509 unii: 19371312D4

Reported adverse events (FAERS/openFDA)#

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