FDA.reportPublic FDA data

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
LabelManufacturerEffective dateType
Vancomycin Hydrochloride for Injection, USPXellia Pharmaceuticals USA LLC | Xellia Pharmaceuticals ApS | Xellia Pharmaceuticals Ltd2022-02-25HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70594-045-032025-07-29C16284748780-13b156c62-2ab9-fb37-e063-e6dba90a4e07Vancomycin Hydrochloride for Injection, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70594-045-01Vancomycin Hydrochloride1 in 1 VIAL, GLASSINJECTION, POWDER, FOR SOLUTION18
70594-045-02Vancomycin Hydrochloride10 in 1 CARTONINJECTION, POWDER, FOR SOLUTION108
70594-045-03Vancomycin Hydrochloride25 in 1 CARTONINJECTION, POWDER, FOR SOLUTION258

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70594-045VANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, FOR SOLUTION [XELLIA PHARMACEUTICALS USA LLC]8Legacy NDC, 3 package rows20221011_7e416822-15cf-4749-9599-2c9710e1674c.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70594-045-01EA - Each70594-045eb897f55-11d8-452b-93b5-2908f8491aa612022-03-09
70594-045-02EA - Each70594-04554b7ab77-ef4c-4236-bcb3-7c117169715c12022-02-07

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 3 of 4 · 74 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Vancomycin HydrochlorideVANCOMYCIN HYDROCHLORIDEGland Pharma Limited65e5f2ee-934c-40d7-967c-00d085f84ffd2025-04-24Warnings, Adverse reactionsExact identifier
unii: 71WO621TJD
vancomycin hydrochlorideVANCOMYCIN HYDROCHLORIDEAdvanced Rx of Tennessee, LLC33127951-1fad-15c1-e063-6294a90a69962025-04-18Warnings, Adverse reactionsExact identifier
unii: 71WO621TJD
Vancomycin HydrochlorideVANCOMYCIN HYDROCHLORIDEHikma Pharmaceuticals USA Inc.b62b7190-48e8-4596-a6ad-9ad455e5c8c62025-03-21Warnings, Adverse reactionsExact identifier
unii: 71WO621TJD
Vancomycin HydrochlorideVANCOMYCIN HYDROCHLORIDEFresenius Kabi USA, LLC9bfe30f8-c662-4af3-bc82-f0102eef89522025-03-17Warnings, Adverse reactionsExact identifier
unii: 71WO621TJD
Vancomycin HydrochlorideVANCOMYCIN HYDROCHLORIDEHospira, Inc.91c050cf-3b2d-48bc-7297-e8dc68225e5a2025-01-16Warnings, Adverse reactionsExact identifier
unii: 71WO621TJD
VANCOMYCIN HYDROCHLORIDEVANCOMYCIN HYDROCHLORIDEFresenius Kabi USA, LLC83ea3faf-fedd-4725-911f-d71a23ec5d5e2024-10-15Warnings, Adverse reactionsExact identifier
rxcui: 1807513
unii: 71WO621TJD
VANCOMYCIN HYDROCHLORIDEVANCOMYCIN HYDROCHLORIDEHIKMA PHARMACEUTICALS USA INC.e4ce7b87-fab4-4b7a-b121-eba136c464ce2024-08-07Warnings, Adverse reactionsExact identifier
unii: 71WO621TJD
VancomycinVANCOMYCIN HYDROCHLORIDESagent Pharmaceuticals06dcfd36-942f-4752-86ad-4c5a6fc3e48f2024-07-19Warnings, Adverse reactionsExact identifier
unii: 71WO621TJD
Vancomycin HydrochlorideVANCOMYCIN HYDROCHLORIDEEugia US LLC4a80cb3f-7410-47aa-af1f-ff83d1b35c552024-07-08Warnings, Adverse reactionsExact identifier
unii: 71WO621TJD
Vancomycin HydrochlorideVANCOMYCIN HYDROCHLORIDEEugia US LLC78984781-3c0b-4b73-ba85-10d60ecb2a282024-07-08Warnings, Adverse reactionsExact identifier
rxcui: 1807513
rxcui: 1807516
unii: 71WO621TJD
Vancomycin HydrochlorideVANCOMYCIN HYDROCHLORIDEMylan Institutional LLC40a88420-5fcb-4715-abc5-595a18fd08d02024-06-07Warnings, Adverse reactionsExact identifier
unii: 71WO621TJD
Vancomycin HydrochlorideVANCOMYCIN HYDROCHLORIDEMylan Institutional LLCcaf22ccb-df75-45ea-a1d0-ccb2d37272fb2024-06-07Warnings, Adverse reactionsExact identifier
unii: 71WO621TJD
Vancomycin HydrochlorideVANCOMYCIN HYDROCHLORIDEXellia Pharmaceuticals USA LLC8403695c-3614-490b-9797-6c5ebcdeef9b2023-12-12Warnings, Adverse reactionsExact identifier
rxcui: 1807513
rxcui: 1807516
unii: 71WO621TJD
Vancomycin HydrochlorideVANCOMYCIN HYDROCHLORIDEMeitheal Pharmaceuticals Inc.45642a47-4712-4a12-8cf7-ee6c2ab8e6c62023-09-29Warnings, Adverse reactionsExact identifier
unii: 71WO621TJD
VANCOMYCIN HYDROCHLORIDEVANCOMYCIN HYDROCHLORIDEFresenius Kabi USA, LLC0576803d-95de-4a48-806a-69ae3fcaf6b02023-08-17Warnings, Adverse reactionsExact identifier
rxcui: 1807513
rxcui: 1807516
unii: 71WO621TJD
Vancomycin hydrochlorideVANCOMYCIN HYDROCHLORIDEEugia US LLC9aa42538-c84e-4886-8d3d-a7dfded5120f2023-08-05Warnings, Adverse reactionsExact identifier
unii: 71WO621TJD
Vancomycin HydrochlorideVANCOMYCIN HYDROCHLORIDEGland Pharma Limited35ecffbc-77d8-4c0d-9b14-6a3cc442dec62023-07-13Warnings, Adverse reactionsExact identifier
unii: 71WO621TJD
Vancomycin HydrochlorideVANCOMYCIN HYDROCHLORIDESagent Pharmaceuticals4843726f-6e79-6e20-2620-4a54616e64792023-06-29Warnings, Adverse reactionsExact identifier
rxcui: 1807513
rxcui: 1807516
unii: 71WO621TJD
Vancomycin HydrochlorideVANCOMYCIN HYDROCHLORIDEAmneal Pharmaceuticals NY LLC3c47d5c4-8cdb-4701-8d7a-8a6e79025b532023-06-23Warnings, Adverse reactionsExact identifier
unii: 71WO621TJD
Vancomycin hydrochlorideVANCOMYCIN HYDROCHLORIDEMeitheal Pharmaceuticals Inc.e5e26614-4119-40cc-b092-48ab97a412872023-03-27Warnings, Adverse reactionsExact identifier
unii: 71WO621TJD

Reported adverse events (FAERS/openFDA)#

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