FDA.reportPublic FDA data

NDC 0409-6533-59 - 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
0409-6533
Requested NDC
0409-6533-59
Package NDCs from labels
0409-6533-11, 0409-6533-01, 0409-6533-21, 0409-6533-59, 0409-6533-31
Manufacturer
Hospira, Inc.
Effective date
2026-04-01
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Vancomycin Hydrochloride for Injection, USP Fliptop Vial For Intravenous UseHospira, Inc.2026-04-01HUMAN PRESCRIPTION DRUG LABEL
Vancomycin Hydrochloride for Injection, USPHospira, Inc.2026-04-01HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0409-6533-01Vancomycin Hydrochloride10 in 1 TRAYINJECTION, POWDER, LYOPHILIZED,1037
0409-6533-11Vancomycin Hydrochloride1 in 1 VIALINJECTION, POWDER, LYOPHILIZED,137
0409-6533-21Vancomycin Hydrochloride10 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,1037
0409-6533-31Vancomycin Hydrochloride10 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,1011
0409-6533-59Vancomycin Hydrochloride1 in 1 VIALINJECTION, POWDER, LYOPHILIZED,111

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0409-6533VANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HOSPIRA, INC.]36Current NDC, Legacy NDC, 3 package rows20250109_f2901045-904f-47bd-74a1-c561facd7f25.zip
0409-6533VANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HOSPIRA, INC.]10Current NDC, Legacy NDC, 2 package rows20250117_c9ea31ec-4c26-452f-b07b-c5f894212cd5.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0409-6533-01EA - Each0409-6533123aa330-1613-47e8-8b64-2d923e829d6112012-07-24
0409-6533-11EA - Each0409-6533607dacf0-0790-424e-80c1-aa54e509249912019-06-19
0409-6533-21EA - Each0409-653334bb68cb-e8e6-4727-9bd7-7c87067b957612021-04-08
0409-6533-31EA - Each0409-6533a4166e67-9554-46e2-b624-307514238adc12020-02-13
0409-6533-49EA - Each0409-65331a1fd307-426e-4620-8ae2-d47604e45a4412012-07-24
0409-6533-59EA - Each0409-6533388228ac-56aa-43f6-a775-15fa6e5d70a712020-02-13
0409-6533-61EA - Each0409-6533b11a7c83-f726-4b5d-a818-fab3acd8c0ce12013-02-11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
VANCOMYCIN HYDROCHLORIDEACTIVE INGREDIENT71WO621TJDVANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HOSPIRA, INC.]17
VANCOMYCINACTIVE MOIETY6Q205EH1VUVANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HOSPIRA, INC.]17
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBVANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HOSPIRA, INC.]17
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IVANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HOSPIRA, INC.]17
VANCOMYCIN HYDROCHLORIDEACTIVE INGREDIENT71WO621TJDVANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HOSPIRA, INC.]1
VANCOMYCINACTIVE MOIETY6Q205EH1VUVANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HOSPIRA, INC.]1
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBVANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HOSPIRA, INC.]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IVANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HOSPIRA, INC.]1

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 6 of 6 · 105 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Vancomycin HydrochlorideVANCOMYCIN HYDROCHLORIDEHikma Pharmaceuticals USA Inc.2f5d3131-8ddc-43a5-91f7-947c531796e72021-06-02Warnings, Adverse reactionsExact identifier
rxcui: 1807513
rxcui: 1807516
unii: 71WO621TJD
Vancomycin HydrochlorideVANCOMYCIN HYDROCHLORIDEMylan Institutional LLC2dc7b3d6-3874-40ac-b8aa-7bcfe2dc0cdf2021-06-01Warnings, Adverse reactionsExact identifier
rxcui: 1807513
rxcui: 1807516
unii: 71WO621TJD
vancomycin hydrochlorideVANCOMYCIN HYDROCHLORIDEMylan Institutional LLC3843d0d7-f70a-4b29-9478-dfb45b02425e2021-06-01Warnings, Adverse reactionsExact identifier
unii: 71WO621TJD
Vancomycin HydrochlorideVANCOMYCIN HYDROCHLORIDESAMSON MEDICAL TECHNOLOGIES LLC93589e71-3a11-4797-9176-8abdb7674a872020-11-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 71WO621TJD
Vancomycin HydrochlorideVANCOMYCIN HYDROCHLORIDEFresenius Kabi, LLCa7e7d990-1d74-459b-ac07-d1c3e13b32042019-01-09Warnings, Adverse reactionsExact identifier
unii: 71WO621TJD

Reported adverse events (FAERS/openFDA)#

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