FDA.reportPublic FDA data

NDC 70594-041-01 - 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
70594-041
Requested NDC
70594-041-01
Package NDCs from labels
70594-041-01, 70594-041-02, 70594-041-03
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
LabelManufacturerEffective dateType
Vancomycin - Xellia Pharmaceuticals USA LLC | Xellia Pharmaceuticals ApSXellia Pharmaceuticals USA LLC | Xellia Pharmaceuticals ApS2023-03-23HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70594-041-01Vancomycin100 mL in 1 BAGINJECTION, SOLUTION10017
70594-041-02Vancomycin6 in 1 CARTONINJECTION, SOLUTION617
70594-041-03Vancomycin12 in 1 CARTONINJECTION, SOLUTION1217

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70594-041VANCOMYCIN INJECTION, SOLUTION [XELLIA PHARMACEUTICALS USA LLC]17Current NDC, Legacy NDC, 3 package rows20230331_60bee69b-be70-412c-9e83-a24a0a8a5e7b.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70594-041-01ML - Milliliter70594-0410812ea9d-7d74-442f-9256-189420ed25b912019-11-12
70594-041-03ML - Milliliter70594-041d9b8cd2b-ba9a-42af-9f22-0395811e122f12019-11-12

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 ยท 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TYZAVANVANCOMYCINHikma Pharmaceuticals USA Inc.72e9c5e2-07cc-4a8b-ba64-b2e7619ea5602026-08-19Warnings, Adverse reactionsExact identifier
application number: NDA211962
rxcui: 1807511
rxcui: 2118448
rxcui: 1807508
rxcui: 2118449
rxcui: 1807510
rxcui: 2387078
rxcui: 2387079
unii: 6Q205EH1VU
VANCOMYCIN HYDROCHLORIDEVANCOMYCIN HYDROCHLORIDEBaxter Healthcare Corporation99e523d8-9bde-43cb-8434-497015e5dcbd2026-06-09Warnings, Adverse reactionsExact identifier
rxcui: 1807511
rxcui: 2118448
rxcui: 1807508
rxcui: 1807510
rxcui: 2387078
VancomycinVANCOMYCINXellia Pharmaceuticals USA LLC60bee69b-be70-412c-9e83-a24a0a8a5e7b2023-03-23Boxed warning, Warnings, Adverse reactionsExact 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): 70594004101
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 HydrochlorideVANCOMYCIN HYDROCHLORIDEHikma Pharmaceuticals USA Inc.86950e7c-0114-47e9-8891-e09e595c48c32022-02-25Warnings, Adverse reactionsExact identifier
unii: 6Q205EH1VU

Reported adverse events (FAERS/openFDA)#

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