FDA.reportPublic FDA data

NDC 63323-203-01 - 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
63323-203
Requested NDC
63323-203-01
Package NDCs from labels
63323-203-01, 63323-203-20, 63323-203-41, 63323-203-26
Manufacturer
Fresenius Kabi USA, LLC | Xellia Pharmaceuticals ApS | GLAND PHARMA LIMITED
Effective date
2025-05-15
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
VANCOMYCIN HYDROCHLORIDE - Fresenius Kabi USA, LLC | Xellia Pharmaceuticals ApS | GLAND PHARMA LIMITEDFresenius Kabi USA, LLC | Xellia Pharmaceuticals ApS | GLAND PHARMA LIMITED2025-05-15HUMAN PRESCRIPTION DRUG LABEL
Vancomycin Hydrochloride - Fresenius Kabi USA, LLCFresenius Kabi USA, LLC2025-03-17HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63323-203-01VANCOMYCIN HYDROCHLORIDE15 mL in 1 VIALINJECTION, POWDER, LYOPHILIZED,1517
63323-203-20VANCOMYCIN HYDROCHLORIDE10 in 1 TRAYINJECTION, POWDER, LYOPHILIZED,1017
63323-203-26Vancomycin Hydrochloride10 in 1 TRAYINJECTION, POWDER, LYOPHILIZED,104
63323-203-41Vancomycin Hydrochloride15 mL in 1 VIALINJECTION, POWDER, LYOPHILIZED,154

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63323-203VANCOMYCIN HYDROCHLORIDE (VANCOMYCIN HYDROCHLORIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC ]16Current NDC, Legacy NDC, 2 package rows20240328_f604d399-fded-4f4f-8efe-af558ed07b9d.zip
63323-203VANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC]4Current NDC, Legacy NDC, 2 package rows20250501_9bfe30f8-c662-4af3-bc82-f0102eef8952.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63323-203-01EA - Each63323-203cdd00921-61cf-411b-a975-57d514a952ef12024-09-09
63323-203-20EA - Each63323-203a0c89ca3-edcf-4660-ac95-437390d0169e12016-11-08
63323-203-26EA - Each63323-203d4c2b3cb-c399-4a96-939b-b07a8625128912018-06-11
63323-203-41EA - Each63323-20321473ee7-3cab-48bc-92ce-44f12d707d0f12018-06-11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
VANCOMYCIN HYDROCHLORIDEACTIVE INGREDIENT71WO621TJDVANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [APP PHARMACEUTICALS, LLC]3
VANCOMYCINACTIVE MOIETY6Q205EH1VUVANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [APP PHARMACEUTICALS, LLC]3

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: 1807513
rxcui: 1807518
rxcui: 1807516
unii: 71WO621TJD
Vancomycin HydrochlorideVANCOMYCIN HYDROCHLORIDEHospira, Inc.c9ea31ec-4c26-452f-b07b-c5f894212cd52026-04-01Warnings, Adverse reactionsExact identifier
rxcui: 1807513
rxcui: 1807516
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
rxcui: 1807513
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
rxcui: 1807513
rxcui: 1807516
unii: 71WO621TJD
Vancomycin HydrochlorideVANCOMYCIN HYDROCHLORIDEXGen Pharmaceuticals DJB, Inc.4239165c-4c15-b78e-e063-6294a90ae6af2025-12-31Warnings, Adverse reactionsExact identifier
unii: 71WO621TJD
Vancomycin HydrochlorideVANCOMYCIN HYDROCHLORIDEGLENMARK PHARMACEUTICALS INC., USA0543b2b5-b1c7-4ad6-b38c-3be0086f0e062025-12-23Warnings, Adverse reactionsExact identifier
rxcui: 1807518
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
rxcui: 1807516
unii: 71WO621TJD
Vancomycin HydrochlorideVANCOMYCIN HYDROCHLORIDESTERISCIENCE SPECIALTIES PRIVATE LIMITED2c355037-6a1e-4846-872a-471ccbdc8d542025-10-31Warnings, Adverse reactionsExact identifier
rxcui: 1807518
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: 1807513
rxcui: 1807518
rxcui: 1807516
unii: 71WO621TJD
Vancomycin HydrochlorideVANCOMYCIN HYDROCHLORIDESagent Pharmaceuticalsf623889c-a47a-4b3a-b3a9-e04051f5c2df2025-05-28Warnings, Adverse reactionsExact identifier
rxcui: 1807518
unii: 71WO621TJD
VANCOMYCIN HYDROCHLORIDEVANCOMYCIN HYDROCHLORIDEFresenius Kabi USA, LLCf604d399-fded-4f4f-8efe-af558ed07b9d2025-05-15Warnings, Adverse reactionsExact identifier
application number: ANDA062663
ndc (package): 63323-221-10
ndc (package): 63323-203-20
ndc (package): 63323-221-01
ndc (package): 63323-203-01
ndc (package): 63323-284-01
ndc (package): 63323-284-20
ndc (product): 63323-221
ndc (product): 63323-284
ndc (product): 63323-203
ndc11 (package): 63323020301
rxcui: 1807513
rxcui: 1807518
rxcui: 1807516
spl id: 570be6c2-649c-46cc-8fcb-3a5a9bd1f7c5
spl set id: f604d399-fded-4f4f-8efe-af558ed07b9d
unii: 71WO621TJD

Reported adverse events (FAERS/openFDA)#

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