NDC 70594-045-01 - 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: 70594-045
Requested NDC: 70594-045-01
Package NDCs from labels: 70594-045-01, 70594-045-02, 70594-045-03
Manufacturer: Xellia Pharmaceuticals USA LLC | Xellia Pharmaceuticals ApS | Xellia Pharmaceuticals Ltd
Effective date: 2022-02-25
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
Vancomycin Hydrochloride for Injection, USP	Xellia Pharmaceuticals USA LLC \| Xellia Pharmaceuticals ApS \| Xellia Pharmaceuticals Ltd	2022-02-25	HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
70594-045-03	2025-07-29	C162847	48780-1	3b156c62-2ab9-fb37-e063-e6dba90a4e07	Vancomycin Hydrochloride for Injection, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
70594-045-01	Vancomycin Hydrochloride	1 in 1 VIAL, GLASS	INJECTION, POWDER, FOR SOLUTION	1	8
70594-045-02	Vancomycin Hydrochloride	10 in 1 CARTON	INJECTION, POWDER, FOR SOLUTION	10	8
70594-045-03	Vancomycin Hydrochloride	25 in 1 CARTON	INJECTION, POWDER, FOR SOLUTION	25	8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70594-045	VANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, FOR SOLUTION [XELLIA PHARMACEUTICALS USA LLC]	8	Legacy NDC, 3 package rows	20221011_7e416822-15cf-4749-9599-2c9710e1674c.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
70594-045-01	EA - Each	70594-045	eb897f55-11d8-452b-93b5-2908f8491aa6	1	2022-03-09
70594-045-02	EA - Each	70594-045	54b7ab77-ef4c-4236-bcb3-7c117169715c	1	2022-02-07

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 · 74 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 unii: 71WO621TJD
Vancomycin Hydrochloride	VANCOMYCIN HYDROCHLORIDE	Fresenius Kabi, LLC	8a35ebee-8650-4ef5-84f5-ab9b55d9bc19	2022-12-02	Warnings, Adverse reactions	Exact identifier application number: ANDA204107 rxcui: 1807516 unii: 71WO621TJD
Vancomycin Hydrochloride	VANCOMYCIN HYDROCHLORIDE	Fresenius Kabi, LLC	418c3c6a-d08d-448c-89c9-54e558c1ce16	2022-12-02	Warnings, Adverse reactions	Exact identifier application number: ANDA204107 rxcui: 1807513 rxcui: 1807516 unii: 71WO621TJD
Vancomycin Hydrochloride	VANCOMYCIN HYDROCHLORIDE	BluePoint Laboratories	f28e3c2b-ae31-4c2a-8178-53962b7b213c	2022-09-22	Warnings, Adverse reactions	Exact identifier unii: 71WO621TJD
VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	Camber Pharmaceuticals, Inc.	3f5dacea-af40-4103-b128-c5e0c0c52fa1	2022-07-20	Warnings, Adverse reactions	Exact identifier rxcui: 1807513 rxcui: 1807516 unii: 71WO621TJD
d0999ed3-4357-4df9-998a-6b6a0e9bba52			7e416822-15cf-4749-9599-2c9710e1674c	2022-02-25	Warnings, Adverse reactions	Exact identifier spl id: d0999ed3-4357-4df9-998a-6b6a0e9bba52 spl set id: 7e416822-15cf-4749-9599-2c9710e1674c
Vancomycin Hydrochloride	VANCOMYCIN HYDROCHLORIDE	Hikma Pharmaceuticals USA Inc.	cae9e5f3-b89a-4a7f-93f7-9471c74a3559	2021-12-07	Warnings, Adverse reactions	Exact identifier unii: 71WO621TJD
Vancomycin Hydrochloride	VANCOMYCIN HYDROCHLORIDE	Fresenius Kabi USA, LLC	d3147f2d-1a72-4923-874b-8fdee2be625e	2021-09-30	Warnings, Adverse reactions	Exact identifier unii: 71WO621TJD
Vancomycin Hydrochloride	VANCOMYCIN HYDROCHLORIDE	Mylan Institutional LLC	ce139a51-0471-4c31-b456-2f889f18dd2b	2021-09-15	Warnings, Adverse reactions	Exact identifier unii: 71WO621TJD
Vancomycin Hydrochloride	VANCOMYCIN HYDROCHLORIDE	Hikma Pharmaceuticals USA Inc.	2f5d3131-8ddc-43a5-91f7-947c531796e7	2021-06-02	Warnings, Adverse reactions	Exact identifier rxcui: 1807513 rxcui: 1807516 unii: 71WO621TJD
Vancomycin Hydrochloride	VANCOMYCIN HYDROCHLORIDE	Mylan Institutional LLC	2dc7b3d6-3874-40ac-b8aa-7bcfe2dc0cdf	2021-06-01	Warnings, Adverse reactions	Exact identifier rxcui: 1807513 rxcui: 1807516 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 unii: 71WO621TJD
Vancomycin Hydrochloride	VANCOMYCIN HYDROCHLORIDE	Fresenius Kabi, LLC	a7e7d990-1d74-459b-ac07-d1c3e13b3204	2019-01-09	Warnings, Adverse reactions	Exact identifier unii: 71WO621TJD

Reported adverse events (FAERS/openFDA)#

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