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 2 of 4 · 74 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Vancomycin HydrochlorideVANCOMYCIN HYDROCHLORIDEHospira, Inc.f2901045-904f-47bd-74a1-c561facd7f252026-04-01Warnings, Adverse reactionsExact identifier
rxcui: 2049890
rxcui: 1807518
unii: 71WO621TJD
Vancomycin HydrochlorideVANCOMYCIN HYDROCHLORIDEHospira, Inc.c9ea31ec-4c26-452f-b07b-c5f894212cd52026-04-01Warnings, Adverse reactionsExact identifier
unii: 71WO621TJD
VANCOMYCIN HYDROCHLORIDEVANCOMYCIN HYDROCHLORIDEPAI Holdings, LLC dba PAI Pharmaae6efaaf-37eb-4510-ba71-5f3dc3abdbd32026-03-31Warnings, Adverse reactionsExact identifier
unii: 71WO621TJD
Vancomycin HydrochlorideVANCOMYCIN HYDROCHLORIDEPlano Pharmaceuticals Inc.4983e3c8-e0f2-b366-e063-6394a90a95572026-03-25Warnings, Adverse reactionsExact identifier
unii: 71WO621TJD
Vancomycin HydrochlorideVANCOMYCIN HYDROCHLORIDEANI Pharmaceuticals, Inc.27d06545-1af0-4dcd-926d-58d4a9492ec32026-03-02Warnings, Adverse reactionsExact identifier
unii: 71WO621TJD
vancomycin hydrochlorideVANCOMYCIN HYDROCHLORIDEANI Pharmaceuticals, Inc.3707ad2e-5c82-4111-a370-e518e5e7e4c52026-03-02Warnings, Adverse reactionsExact identifier
unii: 71WO621TJD
Vancomycin HydrochlorideVANCOMYCIN HYDROCHLORIDEPlano Pharmaceuticals Inc.4983f60c-0f7b-d427-e063-6394a90a838c2026-02-24Warnings, Adverse reactionsExact identifier
unii: 71WO621TJD
vancomycin hydrochlorideVANCOMYCIN HYDROCHLORIDEHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.ab658fbd-68ea-4275-84b1-c3361c860bd32026-02-11Warnings, Adverse reactionsExact identifier
unii: 71WO621TJD
Vancomycin HydrochlorideVANCOMYCIN HYDROCHLORIDEGland Pharma Limited00946db3-d6c5-4534-a870-1ec6e63eda432026-01-30Warnings, Adverse reactionsExact identifier
unii: 71WO621TJD
Vancomycin HydrochlorideVANCOMYCIN HYDROCHLORIDEXGen Pharmaceuticals DJB, Inc.4239165c-4c15-b78e-e063-6294a90ae6af2025-12-31Warnings, Adverse reactionsExact identifier
rxcui: 2049890
rxcui: 2049888
unii: 71WO621TJD
Vancomycin HydrochlorideVANCOMYCIN HYDROCHLORIDEGLENMARK PHARMACEUTICALS INC., USA0543b2b5-b1c7-4ad6-b38c-3be0086f0e062025-12-23Warnings, Adverse reactionsExact identifier
application number: ANDA218140
ndc (package): 68462-478-84
ndc (package): 68462-479-84
ndc (package): 68462-478-30
ndc (package): 68462-477-74
ndc (package): 68462-479-30
ndc (package): 68462-477-20
ndc (product): 68462-477
ndc (product): 68462-478
ndc (product): 68462-479
ndc11 (package): 68462047720
rxcui: 2049890
rxcui: 1807518
rxcui: 2049888
spl id: 210eb04c-a542-44da-b4a3-7e243186b483
spl set id: 0543b2b5-b1c7-4ad6-b38c-3be0086f0e06
unii: 71WO621TJD
VancocinVANCOMYCIN HYDROCHLORIDEANI Pharmaceuticals, Inc.a078d9c2-f89c-4f9f-8ded-60ffb2983c3f2025-12-22Warnings, Adverse reactionsExact identifier
unii: 71WO621TJD
vancomycin hydrochlorideVANCOMYCIN HYDROCHLORIDERedpharm Drug3745b502-c222-e307-e063-6394a90a697e2025-12-18Warnings, Adverse reactionsExact identifier
unii: 71WO621TJD
vancomycin hydrochlorideVANCOMYCIN HYDROCHLORIDEStrides Pharma Science Limitedfac438bd-e08f-438d-ab64-426fc5c5450e2025-11-28Warnings, Adverse reactionsExact identifier
unii: 71WO621TJD
Vancomycin HydrochlorideVANCOMYCIN HYDROCHLORIDEHenry Schein, Inc.1bda7fa4-fdee-410a-a216-02cfbf91632f2025-11-07Warnings, Adverse reactionsExact identifier
unii: 71WO621TJD
Vancomycin HydrochlorideVANCOMYCIN HYDROCHLORIDESTERISCIENCE SPECIALTIES PRIVATE LIMITED2c355037-6a1e-4846-872a-471ccbdc8d542025-10-31Warnings, Adverse reactionsExact identifier
rxcui: 2049890
rxcui: 1807518
rxcui: 2049888
unii: 71WO621TJD
Vancomycin HydrochlorideVANCOMYCIN HYDROCHLORIDECivica, Inc50e4fb19-f603-439c-b193-25a4551153832025-10-13Warnings, Adverse reactionsExact identifier
unii: 71WO621TJD
VANCOMYCIN HYDROCHLORIDEVANCOMYCIN HYDROCHLORIDEHIKMA PHARMACEUTICALS USA INC.8eccafe8-40c9-495a-872d-7f45a98ee7592025-08-13Warnings, Adverse reactionsExact identifier
rxcui: 2049890
rxcui: 1807518
rxcui: 2049888
unii: 71WO621TJD
Vancomycin HydrochlorideVANCOMYCIN HYDROCHLORIDESagent Pharmaceuticalsf623889c-a47a-4b3a-b3a9-e04051f5c2df2025-05-28Warnings, Adverse reactionsExact identifier
application number: ANDA218140
rxcui: 2049890
rxcui: 1807518
rxcui: 2049888
unii: 71WO621TJD
VANCOMYCIN HYDROCHLORIDEVANCOMYCIN HYDROCHLORIDEFresenius Kabi USA, LLCf604d399-fded-4f4f-8efe-af558ed07b9d2025-05-15Warnings, Adverse reactionsExact identifier
rxcui: 1807518
unii: 71WO621TJD

Reported adverse events (FAERS/openFDA)#

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