NDC 80674-210-01 - Sesquient

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: 80674-210
Requested NDC: 80674-210-01
Package NDCs from labels: 80674-210-01, 80674-210-10
Manufacturer: Sedor Pharmaceuticals, LLC | Cangene BioPharma, LLC
Effective date: 2023-12-14
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
Sesquient - Sedor Pharmaceuticals, LLC \| Cangene BioPharma, LLC	Sedor Pharmaceuticals, LLC \| Cangene BioPharma, LLC	2023-12-14	HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
80674-210-10	2023-12-14	C162847	48780-1	d6a99b39-64ed-a426-e053-dadaa90af4c2	These highlights do not include all the information needed to use SESQUIENT safely and effectively. See full prescribing information for SESQUIENT SESQUIENT (fosphenytoin sodium) injection, for intravenous use Initial U.S. Approval: 1996
80674-210-10	2022-01-28	C162847	48780-1	d6a99b39-64ed-a426-e053-dadaa90af4c2	These highlights do not include all the information needed to use SESQUIENT safely and effectively. See full prescribing information for SESQUIENT SESQUIENT (fosphenytoin sodium) injection, for intravenous use Initial U.S. Approval: 1996

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 11 of 11 · 206 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dynamic Eyewash with Eyecup	WATER	Dynamic Safety International	7d3af0f4-0e1f-9ea5-e053-2991aa0af7a2	2018-12-17	Warnings	Exact identifier unii: 059QF0KO0R
Bio Rock Water	ROCK WATER	BioActive Nutritional, Inc.	178bd16d-0d4f-49d8-866b-8ab3a3c6889d	2018-07-30	Warnings	Exact identifier unii: 059QF0KO0R
Fosphenytoin Sodium	FOSPHENYTOIN SODIUM	West-Ward Pharmaceuticals Corp	c92df63b-5140-4213-8d43-8327ff6230b7	2018-01-04	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: 7VLR55452Z
Sterile Water	WATER	Baxter Healthcare Corporation	ef3e79c5-3f58-4b36-a296-64b7d9a651c1	2017-10-17	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
Eye Wash	WATER	CVS Pharmacy	049cee29-7ec2-4d5b-8308-f522acde43a7	2017-03-29	Warnings	Exact identifier unii: 059QF0KO0R
Sterile Water	WATER	Baxter Healthcare Company	210dc9ab-d6ca-4552-ac19-1be17792d290	2016-05-31	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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