FDA.reportPublic FDA data

NDC 0409-6533-11 - 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
0409-6533-11
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 2 of 6 · 105 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
VANCOMYCIN HYDROCHLORIDEVANCOMYCIN HYDROCHLORIDESlate Run Pharmaceuticals, LLC57f58371-3ce6-4983-89df-acba33d1139a2026-05-15Warnings, Adverse reactionsExact identifier
rxcui: 1807513
rxcui: 1807516
unii: 71WO621TJD
Vancomycin HydrochlorideVANCOMYCIN HYDROCHLORIDEGLENMARK PHARMACEUTICALS INC., USA74056e26-57fd-448e-af76-edbccfc3efb72026-04-07Warnings, Adverse reactionsExact identifier
rxcui: 1807513
rxcui: 1807516
unii: 71WO621TJD
Vancomycin HydrochlorideVANCOMYCIN HYDROCHLORIDECivica, Inc3e041ec6-811b-4f26-9303-959cb09d5f572026-04-02Warnings, Adverse reactionsExact identifier
application number: ANDA062912
rxcui: 1807513
unii: 71WO621TJD
Vancomycin HydrochlorideVANCOMYCIN HYDROCHLORIDEHospira, Inc.f2901045-904f-47bd-74a1-c561facd7f252026-04-01Warnings, Adverse reactionsExact identifier
application number: ANDA062911
application number: ANDA062912
ndc (package): 0409-3515-01
ndc (package): 0409-6533-01
ndc (package): 0409-4332-01
ndc (package): 0409-6533-21
ndc (package): 0409-4332-11
ndc (package): 0409-6533-11
ndc (package): 0409-6531-12
ndc (package): 0409-3515-11
ndc (package): 0409-6531-02
ndc (product): 0409-4332
ndc (product): 0409-6533
ndc (product): 0409-3515
ndc (product): 0409-6531
ndc11 (package): 00409653311
rxcui: 1807513
rxcui: 2049890
rxcui: 1807518
rxcui: 1807516
spl id: 10032a19-0373-4c42-b785-f3d915614e30
spl set id: f2901045-904f-47bd-74a1-c561facd7f25
unii: 71WO621TJD
Vancomycin HydrochlorideVANCOMYCIN HYDROCHLORIDEHospira, Inc.c9ea31ec-4c26-452f-b07b-c5f894212cd52026-04-01Warnings, Adverse reactionsExact identifier
application number: ANDA062912
ndc (package): 0409-6533-31
ndc (package): 0409-6533-59
ndc (package): 0409-4332-49
ndc (package): 0409-4332-59
ndc (product): 0409-4332
ndc (product): 0409-6533
rxcui: 1807513
rxcui: 1807516
spl id: d21d38e8-fab1-42bb-87fd-c09e50dc940e
spl set id: c9ea31ec-4c26-452f-b07b-c5f894212cd5
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
Skin Irritations and Itch ReliefAGARICUS MUSCARIUS, ALUMINA, ANAGALLIS ARVENSIS, ANTIMONIUM TARTARICUM, APIS MELLIFICA, ARSENICUM ALBUM, ARSENICUM IODATUM, BOVISTA, CAUSTICUM, DOLICHOS PRURIENS, FAGOPYRUM ESCULENTUM, GRAPHITES, KALI MURIATICUM, MURIATICUM ACIDUM, OLEANDER, PETROLEUM, PIX LIQUIDA, RADIUM BROMATUM (12X, 30X, 1LM), RHUS TOX, SELENIUM METALLICUM, SULPHUR AND URTICA URENS.King Bio Inc.d139d2f1-0369-4963-9f3d-c4cc0f1ea2dd2026-03-10WarningsExact identifier
unii: QTT17582CB
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
Endotoxin Terrain Drops 2143ENDOTOXIN TERRAIN DROPSProfessional Complementary Health Formulas58842566-005a-48b5-973d-20cde2fbd7012026-01-08WarningsExact identifier
unii: QTT17582CB
Abdominal Pain Drops 2051ABDOMINAL PAIN DROPSProfessional Complementary Health Formulasf1b1dde6-bb37-4774-a58c-b4f648f9c2b52026-01-08WarningsExact identifier
unii: QTT17582CB
Vancomycin HydrochlorideVANCOMYCIN HYDROCHLORIDEXGen Pharmaceuticals DJB, Inc.4239165c-4c15-b78e-e063-6294a90ae6af2025-12-31Warnings, Adverse reactionsExact identifier
rxcui: 2049890
unii: 71WO621TJD
Vancomycin HydrochlorideVANCOMYCIN HYDROCHLORIDEGLENMARK PHARMACEUTICALS INC., USA0543b2b5-b1c7-4ad6-b38c-3be0086f0e062025-12-23Warnings, Adverse reactionsExact identifier
rxcui: 2049890
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
HemorrhoidAESCULUS HIPP, HAMAMELIS, ALOE, CALC PHOS, CARBO AN, CARBO VEG, LACHESIS, LYCOPODIUM, MURIATICUM AC, NITRICUM AC, NUX VOM, PAEONIA, RATANHIA, SEPIA, SULPHURNatural Creations, Incdb1b3aef-ba92-417c-b6f6-58e950ed42142025-12-16WarningsExact identifier
unii: QTT17582CB

Reported adverse events (FAERS/openFDA)#

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