FDA.reportPublic FDA data

NDC 67457-705-00 - 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
67457-705
Requested NDC
67457-705-00
Package NDCs from labels
67457-705-00, 67457-705-75
Manufacturer
Mylan Institutional LLC
Effective date
2024-06-07
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Vancomycin Hydrochloride - Mylan Institutional LLCMylan Institutional LLC2024-06-07HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67457-705-00Vancomycin Hydrochloride15 mL in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, LYOPHILIZED,1512
67457-705-75Vancomycin Hydrochloride10 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,1012

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67457-705VANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MYLAN INSTITUTIONAL LLC]12Current NDC, Legacy NDC, 2 package rows20240731_caf22ccb-df75-45ea-a1d0-ccb2d37272fb.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67457-705-00EA - Each67457-70590510713-3e2b-40e1-96b2-c93a8f2119e112018-10-11
67457-705-75EA - Each67457-70538ee1481-3ce7-453e-9d94-03275836e63912018-09-05

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
rxcui: 2049890
rxcui: 1807518
rxcui: 2049888
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
rxcui: 2049890
rxcui: 2049888
unii: 71WO621TJD
Vancomycin HydrochlorideVANCOMYCIN HYDROCHLORIDEFresenius Kabi USA, LLC9bfe30f8-c662-4af3-bc82-f0102eef89522025-03-17Warnings, Adverse reactionsExact identifier
rxcui: 1807518
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
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
unii: 71WO621TJD
Vancomycin HydrochlorideVANCOMYCIN HYDROCHLORIDEMylan Institutional LLC40a88420-5fcb-4715-abc5-595a18fd08d02024-06-07Warnings, Adverse reactionsExact identifier
application number: NDA209481
unii: 71WO621TJD
Vancomycin HydrochlorideVANCOMYCIN HYDROCHLORIDEMylan Institutional LLCcaf22ccb-df75-45ea-a1d0-ccb2d37272fb2024-06-07Warnings, Adverse reactionsExact identifier
application number: NDA209481
ndc (package): 67457-823-99
ndc (package): 67457-705-75
ndc (package): 67457-823-12
ndc (package): 67457-824-15
ndc (package): 67457-822-99
ndc (package): 67457-824-99
ndc (package): 67457-822-25
ndc (package): 67457-705-00
ndc (product): 67457-822
ndc (product): 67457-705
ndc (product): 67457-824
ndc (product): 67457-823
ndc11 (package): 67457070500
rxcui: 2049890
rxcui: 1807518
rxcui: 2049888
rxcui: 2049891
spl id: a0a9dc82-4ffe-4798-8ec4-f4021bf6fc9f
spl set id: caf22ccb-df75-45ea-a1d0-ccb2d37272fb
unii: 71WO621TJD
Vancomycin HydrochlorideVANCOMYCIN HYDROCHLORIDEXellia Pharmaceuticals USA LLC8403695c-3614-490b-9797-6c5ebcdeef9b2023-12-12Warnings, Adverse reactionsExact identifier
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
unii: 71WO621TJD
Vancomycin hydrochlorideVANCOMYCIN HYDROCHLORIDEEugia US LLC9aa42538-c84e-4886-8d3d-a7dfded5120f2023-08-05Warnings, Adverse reactionsExact identifier
rxcui: 2049890
rxcui: 2049888
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
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
rxcui: 1807518
unii: 71WO621TJD

Reported adverse events (FAERS/openFDA)#

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