NDC 68083-174-01 - 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: 68083-174
Requested NDC: 68083-174-01
Package NDCs from labels: 68083-174-01, 68083-174-10
Manufacturer: Gland Pharma Limited
Effective date: 2025-05-09
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 - Gland Pharma Limited	Gland Pharma Limited	2025-05-09	Human Prescription Drug Label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68083-174-01	POLYMYXIN B	1 in 1 VIAL	INJECTION, POWDER, LYOPHILIZED,	1		9
68083-174-10	POLYMYXIN B	10 in 1 CARTON	INJECTION, POWDER, LYOPHILIZED,	10		9

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68083-174	POLYMYXIN B (POLYMYXIN B SULFATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [GLAND PHARMA LIMITED]	9	Current NDC, Legacy NDC, 2 package rows	20250514_dc74dee2-1d0b-4fab-a29b-1755fdb5da75.zip

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 · 366 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Trimethoprim sulfate and Polymyxin B sulfate	TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE	Proficient Rx LP	2c5579eb-ad81-415e-8dcb-9f1c94c897ae	2021-01-01	Warnings, Adverse reactions	Exact identifier unii: 19371312D4
Neomycin and Polymyxin B Sulfates and Hydrocortisone	NEOMYCIN SULFATE, POLYMYXIN B SULFATE, HYDROCORTISONE	Proficient Rx LP	d55f1783-9c49-4f90-9ff8-6f132e7b325e	2021-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: 19371312D4
Neomycin and Polymyxin B Sulfates and Dexamethasone	NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE	Proficient Rx LP	aa7b8a3f-06dd-4190-96a5-f86195bd2197	2021-01-01	Warnings, Adverse reactions	Exact identifier unii: 19371312D4
Neomycin and Polymyxin B Sulfates and Hydrocortisone	NEOMYCIN SULFATE, POLYMYXIN B SULFATE, HYDROCORTISONE	Asclemed USA, Inc.	7c78ec84-8b7c-42f1-a879-3bf27a1daa71	2020-10-30	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: 19371312D4
Water-Jel 3-in-1 Antibiotic	BACITRACIN ZINC, POLYMYXIN B SULFATE, NEOMYCIN SULFATE	Water-Jel Technologies	d5fcaffd-af38-4285-a79c-6df7424c76fa	2017-11-16	Warnings	Exact identifier unii: 19371312D4
CVS Triple Antibiotic	BACITRACIN, NEOMYCIN, POLYMYXIN B	CVS Pharmacy	454bfeed-f58f-003a-e054-00144ff8d46c	2017-01-04	Warnings	Exact identifier unii: 19371312D4

Reported adverse events (FAERS/openFDA)#

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