NDC 70594-057-01 - Vancomycin

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: 70594-057
Requested NDC: 70594-057-01
Package NDCs from labels: 70594-057-01, 70594-057-02
Manufacturer: Xellia Pharmaceuticals USA LLC | Xellia Pharmaceuticals ApS
Effective date: 2023-03-23
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
Vancomycin - Xellia Pharmaceuticals USA LLC \| Xellia Pharmaceuticals ApS	Xellia Pharmaceuticals USA LLC \| Xellia Pharmaceuticals ApS	2023-03-23	HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
70594-057-01	Vancomycin	250 mL in 1 BAG	INJECTION, SOLUTION	250		17
70594-057-02	Vancomycin	6 in 1 CARTON	INJECTION, SOLUTION	6		17

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70594-057	VANCOMYCIN INJECTION, SOLUTION [XELLIA PHARMACEUTICALS USA LLC]	17	Current NDC, Legacy NDC, 2 package rows	20230331_60bee69b-be70-412c-9e83-a24a0a8a5e7b.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
70594-057-01	ML - Milliliter	70594-057	c0f0416c-1e95-4dd2-b2dd-fb800fd9b986	1	2020-09-14
70594-057-02	ML - Milliliter	70594-057	9e19022a-15f6-4e9e-80df-35da106162a0	1	2020-09-14

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 1 of 1 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
TYZAVAN	VANCOMYCIN	Hikma Pharmaceuticals USA Inc.	72e9c5e2-07cc-4a8b-ba64-b2e7619ea560	2026-08-19	Warnings, Adverse reactions	Exact identifier application number: NDA211962 rxcui: 1807511 rxcui: 2118448 rxcui: 1807508 rxcui: 2118449 rxcui: 1807510 rxcui: 2387078 rxcui: 2387079 unii: 6Q205EH1VU
VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	Baxter Healthcare Corporation	99e523d8-9bde-43cb-8434-497015e5dcbd	2026-06-09	Warnings, Adverse reactions	Exact identifier rxcui: 1807511 rxcui: 2118448 rxcui: 1807508 rxcui: 1807510 rxcui: 2387078
Vancomycin	VANCOMYCIN	Xellia Pharmaceuticals USA LLC	60bee69b-be70-412c-9e83-a24a0a8a5e7b	2023-03-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application number: NDA211962 ndc (package): 70594-043-02 ndc (package): 70594-041-02 ndc (package): 70594-042-02 ndc (package): 70594-041-03 ndc (package): 70594-058-02 ndc (package): 70594-056-03 ndc (package): 70594-056-02 ndc (package): 70594-056-01 ndc (package): 70594-042-01 ndc (package): 70594-044-02 ndc (package): 70594-041-01 ndc (package): 70594-058-01 ndc (package): 70594-057-02 ndc (package): 70594-042-03 ndc (package): 70594-057-01 ndc (package): 70594-044-01 ndc (package): 70594-043-01 ndc (product): 70594-056 ndc (product): 70594-042 ndc (product): 70594-058 ndc (product): 70594-057 ndc (product): 70594-041 ndc (product): 70594-043 ndc (product): 70594-044 ndc11 (package): 70594005701 rxcui: 1807511 rxcui: 2118448 rxcui: 1807508 rxcui: 2118449 rxcui: 1807510 rxcui: 2387078 rxcui: 2387079 spl id: e49b6589-caca-4c8f-8c57-55a1ee7774cc spl set id: 60bee69b-be70-412c-9e83-a24a0a8a5e7b unii: 6Q205EH1VU
Vancomycin Hydrochloride	VANCOMYCIN HYDROCHLORIDE	Hikma Pharmaceuticals USA Inc.	86950e7c-0114-47e9-8891-e09e595c48c3	2022-02-25	Warnings, Adverse reactions	Exact identifier unii: 6Q205EH1VU

Reported adverse events (FAERS/openFDA)#

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