FDA.reportPublic FDA data

NDC 0409-6533-49 - 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
0409-6533-49
Package NDCs from labels
0409-6533-11, 0409-6533-01, 0409-6533-21, 0409-6533-59, 0409-6533-31, 0409-6533-49
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
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2012-07-24Indexing - Billing Unit

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 3 of 6 · 105 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
application number: ANDA062911
rxcui: 1807516
unii: 71WO621TJD
Vancomycin HydrochlorideVANCOMYCIN HYDROCHLORIDESTERISCIENCE SPECIALTIES PRIVATE LIMITED2c355037-6a1e-4846-872a-471ccbdc8d542025-10-31Warnings, Adverse reactionsExact identifier
rxcui: 2049890
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: 2049890
rxcui: 1807518
rxcui: 1807516
unii: 71WO621TJD
Vancomycin HydrochlorideVANCOMYCIN HYDROCHLORIDESagent Pharmaceuticalsf623889c-a47a-4b3a-b3a9-e04051f5c2df2025-05-28Warnings, Adverse reactionsExact identifier
rxcui: 2049890
rxcui: 1807518
unii: 71WO621TJD
VANCOMYCIN HYDROCHLORIDEVANCOMYCIN HYDROCHLORIDEFresenius Kabi USA, LLCf604d399-fded-4f4f-8efe-af558ed07b9d2025-05-15Warnings, Adverse reactionsExact identifier
rxcui: 1807513
rxcui: 1807518
rxcui: 1807516
unii: 71WO621TJD
Vancomycin HydrochlorideVANCOMYCIN HYDROCHLORIDEGland Pharma Limited65e5f2ee-934c-40d7-967c-00d085f84ffd2025-04-24Warnings, Adverse reactionsExact identifier
rxcui: 2049890
rxcui: 1807518
unii: 71WO621TJD
vancomycin hydrochlorideVANCOMYCIN HYDROCHLORIDEAdvanced Rx of Tennessee, LLC33127951-1fad-15c1-e063-6294a90a69962025-04-18Warnings, Adverse reactionsExact identifier
unii: 71WO621TJD
Bestmade Natural Products BM182 PelletsGRAPHITES, HEPAR SULF, MERC SOL, MURIATIC ACIDBestmade Natural Products3242e013-2952-2b56-e063-6294a90a16932025-04-08WarningsExact identifier
unii: QTT17582CB
Vancomycin HydrochlorideVANCOMYCIN HYDROCHLORIDEHikma Pharmaceuticals USA Inc.b62b7190-48e8-4596-a6ad-9ad455e5c8c62025-03-21Warnings, Adverse reactionsExact identifier
rxcui: 2049890
unii: 71WO621TJD
Vancomycin HydrochlorideVANCOMYCIN HYDROCHLORIDEFresenius Kabi USA, LLC9bfe30f8-c662-4af3-bc82-f0102eef89522025-03-17Warnings, Adverse reactionsExact identifier
rxcui: 1807518
unii: 71WO621TJD
Bestmade Natural Products BM62AMMONIUM BENZOICUM, AURUM MUR, CALC ARS, CARDUUS MAR, CROTALUS HORRIDUS, MURIATIC ACID, NUX VOM, PHOSPHORUS, VIPERABestmade Natural Products2ce99cb7-fe9e-5da2-e063-6294a90afc4e2025-01-30WarningsExact identifier
unii: QTT17582CB
Vancomycin HydrochlorideVANCOMYCIN HYDROCHLORIDEHospira, Inc.91c050cf-3b2d-48bc-7297-e8dc68225e5a2025-01-16Warnings, Adverse reactionsExact identifier
unii: 71WO621TJD
D-114ALUMINUM METALLICUM, AILANTHUS, BAPTISIA TINCTORIA, FRAGARIA VESCA, YOSCYAMUS NIGER, MURIATICUM ACIDDNA Labsf6f7d369-64ef-0ed9-e053-6294a90a40fa2025-01-13WarningsExact identifier
unii: QTT17582CB
Stress Away Anxiety ReliefACONITUM NAP, ALFALFA, AVENA, CHAMOMILLA, GELSEMIUM, HUMULUS IUPULUS, IGNATIA, KALI ARS, KALI PHOS, MURIATICUM AC, NAT PHOS, PASSIFLORA, PHOSPHORUS, STAPHYSAGRIA, STRAMONIUMSilver Star Brands05e04129-e7c1-4e11-e063-6394a90a09ca2025-01-01WarningsExact identifier
unii: QTT17582CB
Stress Away Anxiety ReliefACONITUM NAP, ALFALFA, AVENA, CHAMOMILLA, GELSEMIUM, HUMULUS LUPULUS, IGNATIA, KALI ARS, KALI PHOS, MURIATICUM AC, NAT PHOS, PASSIFLORA, PHOS, STAPHYSAG, STRAMONIUMSilver Star Brands9d75666e-3214-2bab-e053-2a95a90af7192024-12-03WarningsExact identifier
unii: QTT17582CB
VANCOMYCIN HYDROCHLORIDEVANCOMYCIN HYDROCHLORIDEFresenius Kabi USA, LLC83ea3faf-fedd-4725-911f-d71a23ec5d5e2024-10-15Warnings, Adverse reactionsExact identifier
rxcui: 1807513
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

Reported adverse events (FAERS/openFDA)#

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