NDC 66288-7100-01 - Vancomycin Hydrochloride

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: 66288-7100
Requested NDC: 66288-7100-01
Package NDCs from labels: 66288-7100-1, 66288-7100-01
Manufacturer: SAMSON MEDICAL TECHNOLOGIES LLC | Xellia Pharmaceuticals ApS
Effective date: 2020-11-29
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
VANCOMYCIN - SAMSON MEDICAL TECHNOLOGIES LLC \| Xellia Pharmaceuticals ApS	SAMSON MEDICAL TECHNOLOGIES LLC \| Xellia Pharmaceuticals ApS	2020-11-29	HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
66288-7100-1	Vancomycin Hydrochloride	1 in 1 BAG	INJECTION, POWDER, LYOPHILIZED,	1		5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
66288-7100	VANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SAMSON MEDICAL TECHNOLOGIES LLC]	5	Current NDC, Legacy NDC, 1 package rows	20201130_93589e71-3a11-4797-9176-8abdb7674a87.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
66288-7100-1	EA - Each	66288-7100	14c24c0c-05ca-4058-af26-2a5df03267e4	1	2017-05-04

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 4 of 4 · 73 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Vancomycin Hydrochloride	VANCOMYCIN HYDROCHLORIDE	Fresenius Kabi USA, LLC	0713a847-a334-4b73-af22-343aa06621b9	2023-02-07	Warnings, Adverse reactions	Exact identifier rxcui: 239209 unii: 71WO621TJD
Vancomycin Hydrochloride	VANCOMYCIN HYDROCHLORIDE	Fresenius Kabi, LLC	8a35ebee-8650-4ef5-84f5-ab9b55d9bc19	2022-12-02	Warnings, Adverse reactions	Exact identifier unii: 71WO621TJD
Vancomycin Hydrochloride	VANCOMYCIN HYDROCHLORIDE	Fresenius Kabi, LLC	418c3c6a-d08d-448c-89c9-54e558c1ce16	2022-12-02	Warnings, Adverse reactions	Exact identifier unii: 71WO621TJD
Vancomycin Hydrochloride	VANCOMYCIN HYDROCHLORIDE	BluePoint Laboratories	f28e3c2b-ae31-4c2a-8178-53962b7b213c	2022-09-22	Warnings, Adverse reactions	Exact identifier rxcui: 239209 unii: 71WO621TJD
VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	Camber Pharmaceuticals, Inc.	3f5dacea-af40-4103-b128-c5e0c0c52fa1	2022-07-20	Warnings, Adverse reactions	Exact identifier unii: 71WO621TJD
Vancomycin Hydrochloride	VANCOMYCIN HYDROCHLORIDE	Hikma Pharmaceuticals USA Inc.	cae9e5f3-b89a-4a7f-93f7-9471c74a3559	2021-12-07	Warnings, Adverse reactions	Exact identifier rxcui: 239209 unii: 71WO621TJD
Vancomycin Hydrochloride	VANCOMYCIN HYDROCHLORIDE	Fresenius Kabi USA, LLC	d3147f2d-1a72-4923-874b-8fdee2be625e	2021-09-30	Warnings, Adverse reactions	Exact identifier rxcui: 239209 unii: 71WO621TJD
Vancomycin Hydrochloride	VANCOMYCIN HYDROCHLORIDE	Mylan Institutional LLC	ce139a51-0471-4c31-b456-2f889f18dd2b	2021-09-15	Warnings, Adverse reactions	Exact identifier rxcui: 239209 unii: 71WO621TJD
Vancomycin Hydrochloride	VANCOMYCIN HYDROCHLORIDE	Hikma Pharmaceuticals USA Inc.	2f5d3131-8ddc-43a5-91f7-947c531796e7	2021-06-02	Warnings, Adverse reactions	Exact identifier unii: 71WO621TJD
Vancomycin Hydrochloride	VANCOMYCIN HYDROCHLORIDE	Mylan Institutional LLC	2dc7b3d6-3874-40ac-b8aa-7bcfe2dc0cdf	2021-06-01	Warnings, Adverse reactions	Exact identifier unii: 71WO621TJD
vancomycin hydrochloride	VANCOMYCIN HYDROCHLORIDE	Mylan Institutional LLC	3843d0d7-f70a-4b29-9478-dfb45b02425e	2021-06-01	Warnings, Adverse reactions	Exact identifier unii: 71WO621TJD
Vancomycin Hydrochloride	VANCOMYCIN HYDROCHLORIDE	SAMSON MEDICAL TECHNOLOGIES LLC	93589e71-3a11-4797-9176-8abdb7674a87	2020-11-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application number: ANDA091532 ndc (package): 66288-7100-1 ndc (product): 66288-7100 ndc11 (package): 66288710001 rxcui: 239209 spl id: d607785f-563a-4816-83c4-dfc38bbc29bd spl set id: 93589e71-3a11-4797-9176-8abdb7674a87 unii: 71WO621TJD
Vancomycin Hydrochloride	VANCOMYCIN HYDROCHLORIDE	Fresenius Kabi, LLC	a7e7d990-1d74-459b-ac07-d1c3e13b3204	2019-01-09	Warnings, Adverse reactions	Exact identifier rxcui: 239209 unii: 71WO621TJD

Reported adverse events (FAERS/openFDA)#

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