FDA.reportPublic FDA data

NDC 0143-9161-01 - 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
0143-9161
Requested NDC
0143-9161-01
Package NDCs from labels
0143-9161-01, 0143-9161-25, 0143-9161-10
Manufacturer
HIKMA PHARMACEUTICALS USA INC. | Zhejiang Novus Pharmaceuticals Co., Ltd.
Effective date
2025-08-13
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
VANCOMYCIN HYDROCHLORIDEHIKMA PHARMACEUTICALS USA INC. | Zhejiang Novus Pharmaceuticals Co., Ltd.2025-08-13HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0143-9161-01VANCOMYCIN HYDROCHLORIDE513 mg in 1 VIALINJECTION, POWDER, FOR SOLUTION5135
0143-9161-10VANCOMYCIN HYDROCHLORIDE10 in 1 PACKAGEINJECTION, POWDER, FOR SOLUTION105
0143-9161-25VANCOMYCIN HYDROCHLORIDE25 in 1 PACKAGEINJECTION, POWDER, FOR SOLUTION255

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0143-9161VANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, FOR SOLUTION [HIKMA PHARMACEUTICALS USA INC.]4Current NDC, 3 package rows20241206_8eccafe8-40c9-495a-872d-7f45a98ee759.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0143-9161-01EA - Each0143-916189f7647c-cb84-47b2-8001-07aed674fce312023-09-05
0143-9161-10EA - Each0143-91610792087e-17b5-4ced-8120-f709815cb58112025-07-08
0143-9161-25EA - Each0143-9161d3274a26-512d-476e-8600-0e2397a938c312023-09-05

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 1 of 6 · 115 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Rohto Max StrengthNAPHAZOLINE HYDROCHLORIDE, POLYSORBATE 80The Mentholatum Companye4b49550-1ca3-4bd7-854d-409b53fa5e262026-08-20WarningsExact identifier
unii: 6OZP39ZG8H
Vancomycin HydrochlorideVANCOMYCIN HYDROCHLORIDECameron Pharmaceuticalsbc737938-ae36-460b-a2a8-609f3fe591562026-08-17Warnings, Adverse reactionsExact identifier
unii: 71WO621TJD
vancomycin hydrochlorideVANCOMYCIN HYDROCHLORIDEHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.127d95d1-8070-41ac-8343-3168b0cf13122026-08-05Warnings, Adverse reactionsExact identifier
unii: 71WO621TJD
Vancomycin HydrochlorideVANCOMYCIN HYDROCHLORIDEAvenacy, LLCc757e65b-ca6f-4c00-afe2-025962b43d312026-07-31Warnings, Adverse reactionsExact identifier
application number: NDA210274
rxcui: 2049890
rxcui: 1807518
rxcui: 2049888
unii: 71WO621TJD
vancomycin hydrochlorideVANCOMYCIN HYDROCHLORIDERedpharm Drug57d23aed-a3f7-f92e-e063-6394a90add7d2026-07-30Warnings, Adverse reactionsExact identifier
unii: 71WO621TJD
Droptics Dry Eye ReliefCARBOXYMETHYLCELLULOSE SODIUM,GLYCERIN,POLYSORBATE 80Droptics LLC29d7614b-f4b7-48e2-97c5-d1bff27731d22026-07-22WarningsExact identifier
unii: 6OZP39ZG8H
Vancomycin HydrochlorideVANCOMYCIN HYDROCHLORIDEHospira, Inc.b01aaa02-8f1d-4b57-96a5-337503428af12026-07-20Warnings, Adverse reactionsExact identifier
unii: 71WO621TJD
Vancomycin HydrochlorideVANCOMYCIN HYDROCHLORIDEMeitheal Pharmaceuticals Inc.033efc76-11d5-4a93-91de-56ed41bab9c32026-07-08Warnings, Adverse reactionsExact identifier
rxcui: 1807513
rxcui: 1807516
unii: 71WO621TJD
Vancomycin HydrochlorideVANCOMYCIN HYDROCHLORIDEBryant Ranch Prepack7bbd2c81-33d9-4397-8795-8b9fa28cb5cf2026-06-26Warnings, Adverse reactionsExact identifier
unii: 71WO621TJD
Vancomycin HydrochlorideVANCOMYCIN HYDROCHLORIDEBryant Ranch Prepackd6b8147b-5f93-49ee-8b27-78fe58987c902026-06-26Warnings, Adverse reactionsExact identifier
unii: 71WO621TJD
Rohto Cool ReliefNAPHAZOLINE HYDROCHLORIDE, POLYSORBATE 80The Mentholatum Companydc8f1ff3-87ae-47ca-815f-5a0e34f8cf302026-06-19WarningsExact identifier
unii: 6OZP39ZG8H
Vancomycin HydrochlorideVANCOMYCIN HYDROCHLORIDEBryant Ranch Prepack28fe3c01-cf87-41c0-87fd-f93a405243352026-06-16Warnings, Adverse reactionsExact identifier
unii: 71WO621TJD
BM BM182 DROPSHEPAR SULF, GRAPHITES, MERC SOL, MURIATIC ACIDTotal Operations Management LLC DBA:Bestmade Natural Products Micro5423bde6-3e31-38b0-e063-6294a90afb2d2026-06-13WarningsExact identifier
unii: QTT17582CB
Vancomycin HydrochlorideVANCOMYCIN HYDROCHLORIDEEurofarma, Inc.826510bd-b611-42d9-a574-ec7ee4151ef52026-06-12Warnings, Adverse reactionsExact identifier
rxcui: 1807513
rxcui: 1807516
unii: 71WO621TJD
BM BM182 DROPSHEPAR SULF, GRAPHITES, MERC SOL, MURIATIC ACIDBM Private Limited540d11e3-e4a1-0ca2-e063-6394a90a3c262026-06-12WarningsExact identifier
unii: QTT17582CB
Vancomycin HydrochlorideVANCOMYCIN HYDROCHLORIDEBryant Ranch Prepack6c74b360-022a-4c4d-9e4b-0988219a78fb2026-06-12Warnings, Adverse reactionsExact identifier
unii: 71WO621TJD
Vancomycin HydrochlorideVANCOMYCIN HYDROCHLORIDEBryant Ranch Prepack8193f588-a032-451e-a0a1-819a5ea834c82026-06-12Warnings, Adverse reactionsExact identifier
unii: 71WO621TJD
VANCOMYCIN HYDROCHLORIDEVANCOMYCIN HYDROCHLORIDEBaxter Healthcare Corporation99e523d8-9bde-43cb-8434-497015e5dcbd2026-06-09Warnings, Adverse reactionsExact identifier
unii: 71WO621TJD
Vancomycin HydrochlorideVANCOMYCIN HYDROCHLORIDEBryant Ranch Prepacka09c589b-e7f4-457c-827f-e1bfa1b267002026-05-26Warnings, Adverse reactionsExact identifier
unii: 71WO621TJD
Vancomycin HydrochlorideVANCOMYCIN HYDROCHLORIDEBryant Ranch Prepack786bde33-9aec-4b4d-ba46-90bfd61956d02026-05-26Warnings, Adverse reactionsExact identifier
unii: 71WO621TJD

Reported adverse events (FAERS/openFDA)#

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