FDA.reportPublic FDA data

NDC 68462-477-20 - 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
68462-477
Requested NDC
68462-477-20
Package NDCs from labels
68462-477-20, 68462-477-74
Manufacturer
GLENMARK PHARMACEUTICALS INC., USA | GLAND PHARMA LIMITED
Effective date
2025-12-23
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
VANCOMYCIN - GLENMARK PHARMACEUTICALS INC., USA | GLAND PHARMA LIMITEDGLENMARK PHARMACEUTICALS INC., USA | GLAND PHARMA LIMITED2025-12-23HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68462-477-20Vancomycin Hydrochloride1 in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, LYOPHILIZED,13
68462-477-74Vancomycin Hydrochloride10 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,103

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68462-477VANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [GLENMARK PHARMACEUTICALS INC., USA]2Current NDC, 2 package rows20250427_0543b2b5-b1c7-4ad6-b38c-3be0086f0e06.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68462-477-20EA - Each68462-477b9e1db5b-b8c6-4eb8-8da5-addcd2827a9212025-05-14
68462-477-74EA - Each68462-477a62f10f2-644c-4246-af5d-87e31404f25212025-05-14

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 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
application number: ANDA218140
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
unii: 71WO621TJD
Vancomycin HydrochlorideVANCOMYCIN HYDROCHLORIDEMylan Institutional LLCcaf22ccb-df75-45ea-a1d0-ccb2d37272fb2024-06-07Warnings, Adverse reactionsExact identifier
rxcui: 2049890
rxcui: 1807518
rxcui: 2049888
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.